190232 TM

J CO

MB

O IN

SE

RT

S K

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

CAUTION

United States Federal Law restricts this device to sale by or on the order of a physician.

DESCRIPTION

TMJ Fixation Screws are fabricated from surgical implant grade titanium 6Al-4V ELI alloy (ASTM F136) and are specificallydesigned for use in the fixation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

TMJ Fixation Screws are provided CLEAN AND NON-STERILE and require no additional cleaning prior to sterilization.

Do not use product from damaged or open packaging.

PRECAUTIONS

Always place screws into proper locations in the sterilization case for sterilization.

Screws should only be handled with blunt, smooth-surfaced instruments to avoid damage. Instruments with teeth,serrations, or sharp edges should not be used.

STERILIZATION INSTRUCTIONS

These screws are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

PLACE LABEL HERE

NON-STERILE IMPLANT

PRODUCT INSERTTMJ FIXATION SCREWS

50-0010 rev. F (10/16)

SYMBOL GLOSSARY

2

J 50-0010F 161240.indd 1 10/5/16 2:35 P

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

CAUTION

United States Federal Law restricts this device to sale by or on the order of a physician.

DESCRIPTION

TMJ Fixation Screws are fabricated from surgical implant grade titanium 6Al-4V ELI alloy (ASTM F136) and are specificallydesigned for use in the fixation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

TMJ Fixation Screws are provided CLEAN AND NON-STERILE and require no additional cleaning prior to sterilization.

Do not use product from damaged or open packaging.

PRECAUTIONS

Always place screws into proper locations in the sterilization case for sterilization.

Screws should only be handled with blunt, smooth-surfaced instruments to avoid damage. Instruments with teeth,serrations, or sharp edges should not be used.

STERILIZATION INSTRUCTIONS

These screws are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

PLACE LABEL HERE

NON-STERILE IMPLANT

PRODUCT INSERTTMJ FIXATION SCREWS

50-0010 rev. F (10/16)

SYMBOL GLOSSARY

2

J 50-0010F 161240.indd 1 10/5/16 2:35 P

50-0020 rev. F (10/16)

SYMBOL GLOSSARY

2

DESCRIPTION

TMJ Fixation Instruments are specifically designed for use in the implantation of Patient-Fitted TMJ ReconstructionProstheses and TMJ Fixation Screws provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

Reusable TMJ Fixation Instruments are provided CLEAN AND NON-STERILE and should be cleaned and sterilized prior toeach use.

Do not use product from damaged or open packaging.

PRECAUTIONS

A surgical technique describing the use of these instruments is available. The surgeon should be familiar with theapplication of these instruments prior to use.

Specialty instruments should never be used for tasks that they are not specifically designed to perform. Misuse of aninstrument may result not only in damage to the instrument but also trauma to the patient or operating room personnel.

Avoid storing or transporting instruments in contact with one another as damage may occur.

Use care in handling instruments with cutting edges, points, sharp corners, and hinges as they may cause injury and/ordamage surgical gloves compromising sterility.

Do not use instruments that have been damaged. Damaged instruments should be replaced before further use. Do notattempt to straighten bent instruments as this may compromise the strength of the instrument and lead to subsequentfailure or injury.

CLEANING INSTRUCTIONS

For your safety, be familiar with the procedures for handling contaminated materials at your facility prior to utilizing theseinstructions.

Clean instruments as soon as possible after use. Avoid allowing soiled instruments to dry. Immerse into or use towelsdampened with deionized or distilled water to keep soiled instruments moist prior to cleaning.

Manually or mechanically wash with mild detergent following the detergent manufacturer's instructions for use. Avoidusing extreme detergent concentration levels. Enzyme cleaners and warm/hot water may be used to aid in cleaning. pHneutral cleaners are recommended. If acidic or alkaline solutions are used, follow the manufacturer's recommendationsfor neutralizing the pH by rinsing with water or other neutralizing solution. Highly alkaline cleaners (pH ≥ 12) used in somemechanical washers are not recommended. Avoid prolonged exposure to acidic or alkaline solutions and solutionscontaining chlorides, bromides, or iodine.

After washing, thoroughly rinse instruments with clean deionized or distilled water.

Use of water-soluble medical instrument lubricant is recommended for instruments with moving parts and/or intended tointerfit with other instruments.

Dry completely before sterilization.

Inspect for cleanliness, especially in recesses. The effectiveness of the cleaning process may be evaluated by applying a2% hydrogen peroxide solution. If the solution produces bubbles, repeat the washing process.

Check instruments thoroughly for damage, especially instruments with moving parts or interfits such as a quick-connectmechanism. Do not use instruments that have been damaged. Damaged instruments should be replaced before furtheruse.

STERILIZATION INSTRUCTIONS

These instruments are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE INSTRUMENT

PRODUCT INSERTTMJ FIXATION INSTRUMENTS, REUSABLE

J 50-0020F 161240.indd 1 10/5/16 2:38 P

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE INSTRUMENT

PRODUCT INSERTTMJ FIXATION INSTRUMENTS, SINGLE USE

50-0030 rev. F (10/16)

SYMBOL GLOSSARY

2

DESCRIPTION

TMJ Fixation Instruments are specifically designed for use in the implantation of Patient-Fitted TMJ ReconstructionProstheses and TMJ Fixation Screws provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

Single Use TMJ Fixation Instruments are provided CLEAN AND NON-STERILE and require no additional cleaning prior tosterilization.

This product is intended for single use only.

Do not use product from damaged or open packaging.

PRECAUTIONS

A surgical technique describing the use of these instruments is available. The surgeon should be familiar with theapplication of these instruments prior to use.

Specialty instruments should never be used for tasks that they are not specifically designed to perform. Misuse of aninstrument may result not only in damage to the instrument but also trauma to the patient or operating room personnel.

Avoid storing or transporting instruments in contact with one another as damage may occur.

Use care in handling instruments with cutting edges, points, sharp corners, and hinges as they may cause injury and/ordamage surgical gloves compromising sterility.

Do not use instruments that have been damaged. Damaged instruments should be replaced before further use. Do notattempt to straighten bent instruments as this may compromise the strength of the instrument and lead to subsequentfailure or injury.

STERILIZATION INSTRUCTIONS

These instruments are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

J 50-0030F 161240.indd 1 10/5/16 2:41 P

161240 TMJ 50-0010F 50-0020F 50-0030F BLACK

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

CAUTION

United States Federal Law restricts this device to sale by or on the order of a physician.

DESCRIPTION

TMJ Fixation Screws are fabricated from surgical implant grade titanium 6Al-4V ELI alloy (ASTM F136) and are specificallydesigned for use in the fixation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

TMJ Fixation Screws are provided CLEAN AND NON-STERILE and require no additional cleaning prior to sterilization.

Do not use product from damaged or open packaging.

PRECAUTIONS

Always place screws into proper locations in the sterilization case for sterilization.

Screws should only be handled with blunt, smooth-surfaced instruments to avoid damage. Instruments with teeth,serrations, or sharp edges should not be used.

STERILIZATION INSTRUCTIONS

These screws are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

PLACE LABEL HERE

NON-STERILE IMPLANT

PRODUCT INSERTTMJ FIXATION SCREWS

50-0010 rev. F (10/16)

SYMBOL GLOSSARY

2

J 50-0010F 161240.indd 1 10/5/16 2:35 P

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

CAUTION

United States Federal Law restricts this device to sale by or on the order of a physician.

DESCRIPTION

TMJ Fixation Screws are fabricated from surgical implant grade titanium 6Al-4V ELI alloy (ASTM F136) and are specificallydesigned for use in the fixation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

TMJ Fixation Screws are provided CLEAN AND NON-STERILE and require no additional cleaning prior to sterilization.

Do not use product from damaged or open packaging.

PRECAUTIONS

Always place screws into proper locations in the sterilization case for sterilization.

Screws should only be handled with blunt, smooth-surfaced instruments to avoid damage. Instruments with teeth,serrations, or sharp edges should not be used.

STERILIZATION INSTRUCTIONS

These screws are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

PLACE LABEL HERE

NON-STERILE IMPLANT

PRODUCT INSERTTMJ FIXATION SCREWS

50-0010 rev. F (10/16)

SYMBOL GLOSSARY

2

J 50-0010F 161240.indd 1 10/5/16 2:35 P

50-0020 rev. F (10/16)

SYMBOL GLOSSARY

2

DESCRIPTION

TMJ Fixation Instruments are specifically designed for use in the implantation of Patient-Fitted TMJ ReconstructionProstheses and TMJ Fixation Screws provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

Reusable TMJ Fixation Instruments are provided CLEAN AND NON-STERILE and should be cleaned and sterilized prior toeach use.

Do not use product from damaged or open packaging.

PRECAUTIONS

A surgical technique describing the use of these instruments is available. The surgeon should be familiar with theapplication of these instruments prior to use.

Specialty instruments should never be used for tasks that they are not specifically designed to perform. Misuse of aninstrument may result not only in damage to the instrument but also trauma to the patient or operating room personnel.

Avoid storing or transporting instruments in contact with one another as damage may occur.

Use care in handling instruments with cutting edges, points, sharp corners, and hinges as they may cause injury and/ordamage surgical gloves compromising sterility.

Do not use instruments that have been damaged. Damaged instruments should be replaced before further use. Do notattempt to straighten bent instruments as this may compromise the strength of the instrument and lead to subsequentfailure or injury.

CLEANING INSTRUCTIONS

For your safety, be familiar with the procedures for handling contaminated materials at your facility prior to utilizing theseinstructions.

Clean instruments as soon as possible after use. Avoid allowing soiled instruments to dry. Immerse into or use towelsdampened with deionized or distilled water to keep soiled instruments moist prior to cleaning.

Manually or mechanically wash with mild detergent following the detergent manufacturer's instructions for use. Avoidusing extreme detergent concentration levels. Enzyme cleaners and warm/hot water may be used to aid in cleaning. pHneutral cleaners are recommended. If acidic or alkaline solutions are used, follow the manufacturer's recommendationsfor neutralizing the pH by rinsing with water or other neutralizing solution. Highly alkaline cleaners (pH ≥ 12) used in somemechanical washers are not recommended. Avoid prolonged exposure to acidic or alkaline solutions and solutionscontaining chlorides, bromides, or iodine.

After washing, thoroughly rinse instruments with clean deionized or distilled water.

Use of water-soluble medical instrument lubricant is recommended for instruments with moving parts and/or intended tointerfit with other instruments.

Dry completely before sterilization.

Inspect for cleanliness, especially in recesses. The effectiveness of the cleaning process may be evaluated by applying a2% hydrogen peroxide solution. If the solution produces bubbles, repeat the washing process.

Check instruments thoroughly for damage, especially instruments with moving parts or interfits such as a quick-connectmechanism. Do not use instruments that have been damaged. Damaged instruments should be replaced before furtheruse.

STERILIZATION INSTRUCTIONS

These instruments are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE INSTRUMENT

PRODUCT INSERTTMJ FIXATION INSTRUMENTS, REUSABLE

J 50-0020F 161240.indd 1 10/5/16 2:38 P

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE INSTRUMENT

PRODUCT INSERTTMJ FIXATION INSTRUMENTS, SINGLE USE

50-0030 rev. F (10/16)

SYMBOL GLOSSARY

2

DESCRIPTION

TMJ Fixation Instruments are specifically designed for use in the implantation of Patient-Fitted TMJ ReconstructionProstheses and TMJ Fixation Screws provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

Single Use TMJ Fixation Instruments are provided CLEAN AND NON-STERILE and require no additional cleaning prior tosterilization.

This product is intended for single use only.

Do not use product from damaged or open packaging.

PRECAUTIONS

A surgical technique describing the use of these instruments is available. The surgeon should be familiar with theapplication of these instruments prior to use.

Specialty instruments should never be used for tasks that they are not specifically designed to perform. Misuse of aninstrument may result not only in damage to the instrument but also trauma to the patient or operating room personnel.

Avoid storing or transporting instruments in contact with one another as damage may occur.

Use care in handling instruments with cutting edges, points, sharp corners, and hinges as they may cause injury and/ordamage surgical gloves compromising sterility.

Do not use instruments that have been damaged. Damaged instruments should be replaced before further use. Do notattempt to straighten bent instruments as this may compromise the strength of the instrument and lead to subsequentfailure or injury.

STERILIZATION INSTRUCTIONS

These instruments are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

J 50-0030F 161240.indd 1 10/5/16 2:41 P

161240 TMJ 50-0010F 50-0020F 50-0030F BLACK

50-0020 rev. F (10/16)

SYMBOL GLOSSARY

2

DESCRIPTION

TMJ Fixation Instruments are specifically designed for use in the implantation of Patient-Fitted TMJ ReconstructionProstheses and TMJ Fixation Screws provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

Reusable TMJ Fixation Instruments are provided CLEAN AND NON-STERILE and should be cleaned and sterilized prior toeach use.

Do not use product from damaged or open packaging.

PRECAUTIONS

A surgical technique describing the use of these instruments is available. The surgeon should be familiar with theapplication of these instruments prior to use.

Specialty instruments should never be used for tasks that they are not specifically designed to perform. Misuse of aninstrument may result not only in damage to the instrument but also trauma to the patient or operating room personnel.

Avoid storing or transporting instruments in contact with one another as damage may occur.

Use care in handling instruments with cutting edges, points, sharp corners, and hinges as they may cause injury and/ordamage surgical gloves compromising sterility.

Do not use instruments that have been damaged. Damaged instruments should be replaced before further use. Do notattempt to straighten bent instruments as this may compromise the strength of the instrument and lead to subsequentfailure or injury.

CLEANING INSTRUCTIONS

For your safety, be familiar with the procedures for handling contaminated materials at your facility prior to utilizing theseinstructions.

Clean instruments as soon as possible after use. Avoid allowing soiled instruments to dry. Immerse into or use towelsdampened with deionized or distilled water to keep soiled instruments moist prior to cleaning.

Manually or mechanically wash with mild detergent following the detergent manufacturer's instructions for use. Avoidusing extreme detergent concentration levels. Enzyme cleaners and warm/hot water may be used to aid in cleaning. pHneutral cleaners are recommended. If acidic or alkaline solutions are used, follow the manufacturer's recommendationsfor neutralizing the pH by rinsing with water or other neutralizing solution. Highly alkaline cleaners (pH ≥ 12) used in somemechanical washers are not recommended. Avoid prolonged exposure to acidic or alkaline solutions and solutionscontaining chlorides, bromides, or iodine.

After washing, thoroughly rinse instruments with clean deionized or distilled water.

Use of water-soluble medical instrument lubricant is recommended for instruments with moving parts and/or intended tointerfit with other instruments.

Dry completely before sterilization.

Inspect for cleanliness, especially in recesses. The effectiveness of the cleaning process may be evaluated by applying a2% hydrogen peroxide solution. If the solution produces bubbles, repeat the washing process.

Check instruments thoroughly for damage, especially instruments with moving parts or interfits such as a quick-connectmechanism. Do not use instruments that have been damaged. Damaged instruments should be replaced before furtheruse.

STERILIZATION INSTRUCTIONS

These instruments are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE INSTRUMENT

PRODUCT INSERTTMJ FIXATION INSTRUMENTS, REUSABLE

J 50-0020F 161240.indd 1 10/5/16 2:38 P

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE INSTRUMENT

PRODUCT INSERTTMJ FIXATION INSTRUMENTS, SINGLE USE

50-0030 rev. F (10/16)

SYMBOL GLOSSARY

2

DESCRIPTION

TMJ Fixation Instruments are specifically designed for use in the implantation of Patient-Fitted TMJ ReconstructionProstheses and TMJ Fixation Screws provided by TMJ Concepts.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no latex materials.

WARNINGS

Single Use TMJ Fixation Instruments are provided CLEAN AND NON-STERILE and require no additional cleaning prior tosterilization.

This product is intended for single use only.

Do not use product from damaged or open packaging.

PRECAUTIONS

A surgical technique describing the use of these instruments is available. The surgeon should be familiar with theapplication of these instruments prior to use.

Specialty instruments should never be used for tasks that they are not specifically designed to perform. Misuse of aninstrument may result not only in damage to the instrument but also trauma to the patient or operating room personnel.

Avoid storing or transporting instruments in contact with one another as damage may occur.

Use care in handling instruments with cutting edges, points, sharp corners, and hinges as they may cause injury and/ordamage surgical gloves compromising sterility.

Do not use instruments that have been damaged. Damaged instruments should be replaced before further use. Do notattempt to straighten bent instruments as this may compromise the strength of the instrument and lead to subsequentfailure or injury.

STERILIZATION INSTRUCTIONS

These instruments are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJConcepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurancelevel of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization, 15 minutes @ 270-275°F (133-135°C)

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

J 50-0030F 161240.indd 1 10/5/16 2:41 P

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILE and IS NOT INTENDED TO BE STERILIZED. No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REPEC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILE and IS NOT INTENDED TO BE STERILIZED. No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REPEC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILE and IS NOT INTENDED TO BE STERILIZED. No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REPEC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILE and IS NOT INTENDED TO BE STERILIZED. No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive (805) 650-3391 PhoneVentura, CA 93003 (805) 650-3392 FaxUSA www.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REPEC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILEand IS NOT INTENDED TO BE STERILIZED.No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive(805) 650-3391 PhoneVentura, CA93003(805) 650-3392 FaxUSAwww.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REP EC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILEand IS NOT INTENDED TO BE STERILIZED.No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive(805) 650-3391 PhoneVentura, CA93003(805) 650-3392 FaxUSAwww.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REP EC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILEand IS NOT INTENDED TO BE STERILIZED.No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive(805) 650-3391 PhoneVentura, CA93003(805) 650-3392 FaxUSAwww.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REP EC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

PRODUCT INSERTANATOMICAL BONE MODEL

DESCRIPTION

This Anatomical Bone Model is intended to be used by the surgeon as an anatomical reference in planning and performingthe implantation of Patient-Fitted TMJ Reconstruction Prostheses provided by TMJ Concepts specifically for the patientidentified on the front of this product insert. The model is produced from a CT scan of the patient's mandible and maxilla.

Refer to the product insert included with TMJ implant components for further information.

This product and its packaging contain no natural rubber latex.

WARNINGS

The bone model is provided CLEAN AND NON-STERILEand IS NOT INTENDED TO BE STERILIZED.No sterilizationprocesses have been demonstrated to produce adequate bone model sterility assurance levels. Sterilization processes mayhave detrimental effects on the accuracy and integrity of the model.

Implants should not be placed in contact with bone model surfaces nor should the model be introduced into the sterilefield at the time of surgery due to the possibility of contamination from residual substances on the model.

PRECAUTION

This bone model contains fragile features. Handle with care.

LIMITED WARRANTY

TMJ Concepts warrants that this product meets the manufacturer's specifications and is free from manufacturing defectsat the time of delivery. This warranty specifically excludes defects resulting from misuse, abuse, or improper handling ofthe product subsequent to receipt by the purchaser.

TMJ Concepts warrants that this model accurately represents the anatomical data provided by the CT scan site in all areasnot containing metallic artifact. TMJ Concepts does not warrant the accuracy of the provided scan data or that the datamatches the patient's anatomy at the time of surgery.

SYMBOL GLOSSARY

50-0050 rev. E (10/15)

TMJ CONCEPTS 2233 Knoll Drive(805) 650-3391 PhoneVentura, CA93003(805) 650-3392 FaxUSAwww.TMJConcepts.com

PLACE LABEL HERE

NON-STERILE BONE MODEL

Do Not Re-use

Use-by Date (Expiration Date)

Part Number

Lot or Batch Code

Non-sterile

Sterilized Using Ethylene Oxide

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

2

NONSTERILE

LOT

REF

REP EC

STERILE EO

TMJ 50-0050 rev. E (10-15) FINAL 151550_340613 12/7/15 10:58 AM Page 1

100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25% 100% 75% 50% 25%

50-0010 rev. G (12/19) 50-0010 rev. G (12/19)

50-0020 rev. G (12/19)

50-0030 rev. G (12/19)

50-0050 rev. F (12/19)

6059 King DriveVentura, CA 93003USA

6059 King DriveVentura, CA 93003USA

6059 King DriveVentura, CA 93003USA

6059 King DriveVentura, CA 93003USA

6059 King DriveVentura, CA 93003USA