forerunner plating system - zimmer biometbiomet trauma, including screws, biomet® vision footring...

At Biomet, engineering excellence is our heritage and

our passion. For over 25 years, through various

divisions worldwide, we have applied the most

advanced engineering and manufacturing technology

to the development of highly durable systems for a

wide variety of surgical applications.

To learn more about this product,

contact your local Biomet Sales Representative today.

Forerunner™ Plating System

©2013 Biomet Orthopedics • Form No. BMET0354.0 • REV011513

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.

This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website.

Responsible ManufacturerBiomet, Inc. P.O. Box 58756 E. Bell DriveWarsaw, Indiana 46581-0587 USA

www.biomet.com

Rx only.

Forerunner™ Plating System

Surgical Technique

Contents

Introduction .................................................... Page 1

Indications And Contraindications ................. Page 2

System Design Features ................................

Instrumentation .............................................. Page 4

Tray Layout ..................................................... Page 8

Relevant Anatomy – Midfoot .......................... Page 9

Surgical Technique ........................................ Page 10

Surgical Technique For Lisfranc Fractures .... Page 14

Ordering Information ...................................... Page 16

Package Insert Information ............................ Page 18

Further Information ........................................ Page 21

1

Introduction

Implant Rationale

The Biomet Forerunner Plating System is a comprehensive

plating system designed for fixation of boney pathology

for the foot and ankle. The wide range of plates with varying

lengths between screw holes, as well as the multiple screw

diameters made available to the foot and ankle surgeon provide

for unlimited combinations for the unique and complicated

boney structure of the foot. In addition, providing non-locking,

fixed angle locking and poly-axial locking options provides the

surgeon even more choices for fixation of the most complex

deformities. The Forerunner Plating System can be used in

combination with many other foot and ankle products offered by

Biomet Trauma, including screws, Biomet® Vision™ FootRing™

System and XS Rail external fixation systems as well as a wide

range of osteobiologics and bone grafts to achieve optimized

foot and ankle reconstruction.

Source: Charles Zelen, D.P.M.

2

Indications And Contraindications

INDICATIONS

The Biomet® Forerunner Plating System is intended for adult

or pediatric patients as indicated for pelvic, small and long

bone fracture fixation and fixation of bones that have been

surgically prepared (osteotomy) for correction of deformity or

arthrodesis. Indications for use include internal fixation of the

tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna,

radius, middle hand and middle foot and forefoot bones.

Specific indications for midfoot/forefoot procedures:

1. Treatment of fractures and fracture dislocations of the

midfoot/forefoot

2. Malunions

3. Non-unions

4. Joint fusions/arthrodesis

5. Corrective osteotomies for deformities

These procedures in the midfoot/forefoot may be indicated as

a result of trauma, deformity, osteoarthritis and rheumatoid

arthritis.

Patient selection factors to be considered include:

1. Need for alignment and stabilization of bone fractures.

2. Ability and willingness of the patient to follow postoperative

care instructions until healing is complete.

3. A good nutritional state of the patient.

4. Vascular status of patient.

CONTRAINDICATIONS

1. Active infection.

2. Patient conditions including blood supply limitations, and

insufficient quantity or quality of bone.

3. Patients with mental or neurologic conditions who are

unwilling or incapable of following postoperative care

instructions or materials.

4. Foreign body sensitivity. Where material sensitivity is

suspected, testing is to be completed prior to implantation

of the device.

3

System Design Features

Plates And Screws

The Forerunner Plating System is a versatile system that

allows for constrained and semi-constrained fixation. This low

profile system features a one step locking mechanism and

a unique open design for intra-operative visualization of the

graft. This exclusive locking mechanism features SphereLock ™

technology that allows for simplified and secure locking.

SphereLock Technology

As the screw head advances into the recess of the plate,

the threads on the bone screw interlock with the threads

of the plate. The threads of the plate and the bone screw

resemble a sphere. In general, a spherical thread design has

the ability to self-center itself. In addition, a unique feature

of the Biomet Forerunner Plating System is the Variable Bone

Screw. The Variable Bone Screw features a poly-axial head.

The head is independent of the screw shaft and creates a 20°

cone of angulation.

• Titanium alloy provides strength and biocompatibility

• Locking and Non Locking options for the surgeon

• Fixed and Variable Angle options for screw placement

• Multiple screw diameters (4.0mm and 4.75mm)

• Screw lengths from 12mm through 50mm

• Plating options with 4, 6, 8 hole plates with variable distances between holes to optimize plating selection for the surgeon

Plates Available From 12mm To 66mm In Length

• 4-Hole Plate (12mm to 22mm)



• All Plates have a 1.9mm profile

Variable Bone Screw20°

Instrumentation

4

PN 14-401420Plate Bending Handles

PN 14-401416Reducer Sleeve

PN 14-4014172.5mm Temporary Fixator (Whirlybird)

PN 14-401413AO Screw Inserter Shaft (150mm)

PN 14-401424AO Screw Inserter Shaft (80mm)

PN 14-401414AO Awl Shaft

Temporary fixation device attachment

for precise placement of plate

in the foot and ankle

5

PN 14-401418Extreme Angle Plate Bender

PN 14-401419Mid-Plate Bender

PN 14-401422Baby Bennett Retractor

PN 14-401415Screw Depth Gauge

PN 14-401421Baby Hohman Retractor

PN 14-401423Screw Remover Lag Plate

Instrumentation (Continued)

6

PN 14-401425Fixed Drill Guide

PN 14-401426Variable Drill Guide

PN 14-401427Fixed Drill Guide Tube

PN 14-401428Variable Drill Guide Tube

7

PN 14-4014302.0mm x 150mm Drill

PN 14-4014312.8mm x 150mm Drill

PN 14-4014342.0mm x 230mm Drill

PN 14-4014352.8mm x 230mm Drill

Tray Layout

Instrumentation tray optimized for the foot and ankle surgeon

complete with AO compatible handles and specialized

instrumentation dedicated to the lower extremity surgeon.

Instrument Loaner Kit PN 14-401400

Instrument Sterilization Tray PN 14-401410

8

See page 16 for Complete Instrument and Implant Set List

Implant Loaner Kit PN 14-401401

Implant Sterilization Tray PN 14-401411

4-Hole Forerunner Plate Caddy



Forerunner Screw Caddy

BioDrive Implant Caddy1.6mm x 6” Threaded K-Wires

Relevant Anatomy – Midfoot

9

First Metatarsal

Second Metatarsal

Third Metatarsal

Fourth Metatarsal

Fifth Metatarsal

Lateral Cuneiform

Cuboid

Calcaneous

Medial Cuneiform

Intermediate Cuneiform

Navicular

Talus

Surgical Technique

10

Surgical Exposure of the Lateral Column

Reduction of Deformity, Placement of Bone Wedge, and

Propeller Head™ Screw for Compression


Step 1 - Surgical Exposure

The dissection and surgical exposure are determined by

the boney segments to be stabilized and the severity of the

deformity. Sufficient exposure for insertion of the plates and

screws is recommended unless a percutaneous technique is

being utilized.

NOTE: Unnecessary tension on the skin and soft tissue

structures is not recommended since this may lead

to wound dehiscence and breakdown.

Step 2 - Deformity Correction

Once exposure of the boney segments is obtained, appropriate

boney resections are then performed and deformity is then

corrected. In some cases, bone grafting may be utilized to

assist in achieving optimal correction of deformity. In fusion

procedures the surgeon may consider the use of cannulated

screws for compression of the boney fragments prior to

placing the Forerunner plates into position.

11

Step 3 - Preparation Of Forerunner Plate

The Forerunner Plating System offers unique Plate Benders

(PN 14-401420) that allow for an exact contour of the plate

specific for the foot and ankle deformity to be addressed.

Step 4 - Application Of The Forerunner Plate

A specialized instrument is included in the system for

placement of the Forerunner plate known as the Temporary

Fixation Device (PN 14-401416 and PN 14-401417).

This instrument will assist the surgeon in exact placement of

the plate as well as assist in close adherence of the plate to

the bone interphase and prevent prominence of the plate on

the surrounding soft tissues. One or two of these devices can

be used based on surgeon preference.

Bending of the plate to contour to the boney surface

PN 14-401420

Use of the temporary fixation device for plate adherence

to bone


PN 14-401416PN 14-401417

Surgical Technique (Continued)

12

Step 5 - Placement Of Screws

The surgeon may choose non-locking, fixed angle locking

or poly-axial locking screws. In addition, the surgeon has

the option of the 4.0mm standard or 4.75mm relief screw.

The lengths of the screws range in total from 10mm to 50mm.

All the screws within the Forerunner Plating System are self

drilling and self tapping, however in hard bone the surgeon

may choose to drill. A drill guide is available to pre-drill with

a specialized Variable Angle Drill Guide (PN 14-401426 or PN

14-401428) for use with the poly-axial locking screws. The

variable angle guide should sit firmly into the drill hole to

ensure that the screw is not inserted beyond the 20 degree

cone of angulation required for achieving locking.

NOTE: In addition, the drill bit is calibrated so that the surgeon

can measure directly from the drill bit to prevent the need for

use of another measuring device.

Use of the Variable Angle Drill Guide

A close up view of the variable angle locking screw

prior to insertion


13

Placement Of Screws (Continued)

Insertion of the variable angle locking screw into the

Forerunner plate

Final insertion of six variable angle locking screws into the

lateral column with a six-hole Forerunner plate

Final insertion of four variable angle locking screws into the

medial column with a four-hole Forerunner plate


Surgical Technique For Lisfranc Fractures

14

Introduction

A plate applied to the plantar (tension) side of the medial

midfoot provides a strong, sturdy construct for arthrodesis

and ambulation after Lisfranc’s dislocation. The tension

side is able to maintain correction over high and repetitive

loading, which is ideal for arthrodesis and early ambulation of

neuropathic joints. Research has shown that a plate applied

to the plantar (tension) aspect of the medial midfoot provides

a stronger, sturdier construct than does midfoot fusion with

screw fixation.* Studies have also revealed that a plantar plate

allows significantly less initial displacement and maintains

stabilization at a much higher load. By maintaining correction

over high and repetitive loading, the patient should be able to

ambulate earlier while maintaining arthrodesis.

Technique

Step 1 - Patient Positioning

Patients are taken to the operating room and placed in a

supine position. Following admission of general anesthesia,

cotton padding is placed over the upper thigh of the foot being

operated on and a pneumatic thigh tourniquet is applied. The

foot is then prepped and draped in the usual sterile manner.

Step 2 - Incision 1

The tourniquet is applied and elevated. Attention is directed to

the Achilles tendon where a linear incision is made over the

distal 1/3 of the leg.

The tendoachilles lengthening is performed. Approximately

2cm of lengthening is achieved. The paratenon was

re-approximated using 3.0 vicryl. The subcutaneous tissue

is closed using 3.0 vicryl, skin was closed in a horizontal

mattress type stitch using 4.0 nylon.

Step 3 - Incision 2

Attention is then directed to the planter medial aspect of the foot.

A straight incision is made beginning at the talonavicular joint

and extending to the distal one-third of the 1st metatarsal shaft.

The incision is deepened via sharp and blunt dissection

down to the 1st metatarsal, medial cuneiform, and

navicular. A full thickness tissue flap is reflected off of the

tarsometatarsal joints.

15

Step 4 - Necrotic Bone Removal

Attention is directed to the base of Lisfranc’s articulation.

An osteotome is used to remove approximately 1.0cm block

of necrotic bone across Lisfranc’s joint, down to good healthy

bleeding bone. If necessary, a second incision can be made

on the lateral aspect of the foot between the 4th and 5th

metatarsals. This incision is deepened down to the base of

the metatarsals and cuboid. All necrotic bone from lateral to

medial is removed, completing the resection of neuropathic

bone across Lisfranc’s joint.

The same procedure is performed through the innominate i.e.

naviculo-cuneiform joints, depending on the extension

of neuroarthropathy destruction, in order to restore the medial

arch of the foot.

Step 5 - Plate Insertion

The Lisfranc’s joint is adducted and held into a plantar flexed

position using two 1.6mm Wires (PN 245020) for temporary

fixation. Next, the Forerunner plate is eccentrically loaded and

applied to the plantar aspect of the first metatarsal, medial

cuneiform and navicular.

One cortical screw is placed outside of the Forerunner plate

in an oblique fashion, seating on the medial wall of the first

metatarsal and aiming at the lateral edge of the navicular.

Its length depends on the extension of the debrided region.

A second cortical screw is inserted outside of the Forerunner

plate from the medial cuneiform or navicular into the 2nd or

3rd metatarsal base. No fixation is used on the 4th and 5th

rays. Autogenous cancellous bone might be used to fill any

void or space at the arthrodesis site.

Step 6 - Wound Closure And Dressing

The incisions are then dressed using betadine soaked adaptic,

4 x 4’s, and kling. A dry sterile dressing is applied, followed by

a posterior splint or Jones compression dressing.

16

Ordering Information

Instruments

Catalog # Description Qty.

14-401410 Instrument Tray 1

14-401411 Implant Tray 1

14-401415 Screw Depth Gauge 1

14-401413 AO Screw Inserter Shaft (150mm) 1

14-401414 AO Awl Shaft 1

14-401418 Extreme Angle Plate Bender 1

14-401420 Plate Bending Handles 2

14-401425 Drill Guide (Fixed) 1

14-401426 Drill Guide (Variable) 1

14-401427 Drill Guide Tube (Fixed) 2

14-401428 Drill Guide Tube (Variable) 2

14-401421 Baby Hohman 2

14-401422 Baby Bennett 2

14-401424 AO Screw Inserter Shaft (80mm) 2

22894 Small Bone Reducing Forceps 1

22896 Large Bone Reducing Forceps 1

14-401416 Reducer Sleeve 2

22880 AO Ratcheting Handle 2

14-401423 Screw Remover Lag Plate 1

14-401419 Mid-Plate Bender 1

14-401417 Temporary Fixator (Whilybird - 2.5mm) 2

14-401430 2.0mm x 150mm Drill 2

14-401434 2.0mm x 230mm Drill 1

14-401431 2.8mm x 150mm Drill 1

14-401435 2.8mm x 230mm Drill 1

Plates


14-401112 4-Hole Plate - 12mm Length 2






Plates (Continued)
























4.0mm Locking Variable Self-Drilling Screws


14-401512 4.0mm x 12mm 4

14-401514 4.0mm x 14mm 4

14-401516 4.0mm x 16mm 8

14-401518 4.0mm x 18mm 8

14-401520 4.0mm x 20mm 8

14-401522 4.0mm x 22mm 8

14-401524 4.0mm x 24mm 8

14-401526 4.0mm x 26mm 8

14-401528 4.0mm x 28mm 8

14-401530 4.0mm x 30mm 8

14-401535 4.0mm x 35mm 4

17

4.0mm Locking Variable Self-Drilling Screws (Continued)


14-401540 4.0mm x 40mm 4

14-401545 4.0mm x 45mm 0*

14-401550 4.0mm x 50mm 0*

* The part is not included in set, but can be ordered separately.

4.75mm Locking Variable Salvage Screws


14-401712 4.75mm x 12mm 0*

14-401714 4.75mm x 14mm 0*

14-401716 4.75mm x 16mm 0*

14-401718 4.75mm x 18mm 0*

14-401720 4.75mm x 20mm 0*

14-401722 4.75mm x 22mm 0*

14-401724 4.75mm x 24mm 0*

14-401726 4.75mm x 26mm 0*

14-401728 4.75mm x 28mm 0*

14-401730 4.75mm x 30mm 0*

14-401735 4.75mm x 35mm 0*

14-401740 4.75mm x 40mm 0*

14-401745 4.75mm x 45mm 0*

14-401750 4.75mm x 50mm 0*


4.0mm Locking Fixed Self-Drilling Screws


14-401612 4.0mm x 12mm 4

14-401614 4.0mm x 14mm 4

14-401616 4.0mm x 16mm 8

14-401618 4.0mm x 18mm 8

14-401620 4.0mm x 20mm 8

14-401622 4.0mm x 22mm 8

14-401624 4.0mm x 24mm 8

14-401626 4.0mm x 26mm 8

14-401628 4.0mm x 28mm 8

14-401630 4.0mm x 30mm 8

14-401635 4.0mm x 35mm 4

14-401640 4.0mm x 40mm 4

14-401645 4.0mm x 45mm 0*

14-401650 4.0mm x 50mm 0*


4.0mm Non-Locking Fixed Self-Drilling Screws


14-402012 4.0mm x 12mm 2

14-402014 4.0mm x 14mm 2

14-402016 4.0mm x 16mm 2

14-402018 4.0mm x 18mm 2

14-402020 4.0mm x 20mm 2

14-402022 4.0mm x 22mm 2

14-402024 4.0mm x 24mm 2

14-402026 4.0mm x 26mm 2

14-402028 4.0mm x 28mm 2

14-402030 4.0mm x 30mm 2

14-402035 4.0mm x 35mm 2

14-402040 4.0mm x 40mm 2

14-402045 4.0mm x 45mm 0*

14-402050 4.0mm x 50mm 0*


4.75mm Non-Locking Fixed Self-Drilling - Salvage Screws


14-402212 4.75mm x 12mm 0*

14-402214 4.75mm x 14mm 4

14-402216 4.75mm x 16mm 0*

14-402218 4.75mm x 18mm 4

14-402220 4.75mm x 20mm 0*

14-402222 4.75mm x 22mm 4

14-402224 4.75mm x 24mm 0*

14-402226 4.75mm x 26mm 4

14-402228 4.75mm x 28mm 0*

14-402230 4.75mm x 30mm 4

14-402235 4.75mm x 35mm 4

14-402240 4.75mm x 40mm 4

14-402245 4.75mm x 45mm 0*

14-402250 4.75mm x 50mm 0*


Package Insert Information

18

DESCRIPTION

Biomet® manufactures a variety of internal fixation devices

intended to aid in the alignment and stabilization of fractures

to the skeletal system. These implantable devices include bone

screws and bone plates. Instrumentation has been designed

specifically for use with each system of implants.

MATERIALS

Titanium Alloy

INDICATIONS

The Biomet® Forerunner Plating System is intended for adult

or pediatric patients as indicated for pelvic, small and long

bone fracture fixation and fixation of bones that have been

surgically prepared (osteotomy) for correction of deformity or

arthrodesis. Indications for use include internal fixation of the

tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna,

radius, middle hand and middle foot and forefoot bones.

Specific indications for midfoot/forefoot procedures:

1. Treatment of fractures and fracture dislocations of the

midfoot/forefoot

2. Malunions

3. Non-unions

4. Joint fusions/arthrodesis

5. Corrective osteotomies for deformities

These procedures in the midfoot/forefoot may be indicated as

a result of trauma, deformity, osteoarthritis and rheumatoid

arthritis.

Patient selection factors to be considered include:

1. Need for alignment and stabilization of bone fractures.

2. Ability and willingness of the patient to follow postoperative

care instructions until healing is complete.

3. A good nutritional state of the patient.

4. Vascular status of patient.

CONTRAINDICATIONS

1. Active infection.

2. Patient conditions including blood supply limitations, and

insufficient quantity or quality of bone.

3. Patients with mental or neurologic conditions who are

unwilling or incapable of following postoperative care

instructions or materials.

4. Foreign body sensitivity. Where material sensitivity is

suspected, testing is to be completed prior to implantation

of the device.

WARNINGS

Internal fixation devices aid the surgeon in the alignment

and stabilization of skeletal fractures and provide a means of

fracture management in reconstructive surgical applications.

While these devices are generally successful in attaining these

goals, they cannot be expected to replace normal healthy bone

or withstand the stress placed upon the device by full or partial

weight bearing or load bearing, particularly in the presence of

nonunion, delayed union, or incomplete healing. Metallic bone

fixation devices are internal splints that align the fracture until

normal healing occurs. The size and shape of bones and soft

tissue place limitations on the size and strength of implants. If

there is delayed union or nonunion of bone in the presence of

weight bearing, or load bearing, the implant could eventually

break. Therefore, it is important that immobilization (use of

external support, walking aids, braces, etc.) of the fracture site

be maintained until firm bony union (confirmed by clinical and

radiographic examination) is established. Surgical implants are

subject to repeated stresses in use, which can result in fatigue

fracture. Factors such as the patient’s weight, activity level,

and adherence to weight bearing or load bearing instructions

have an effect on the service life of the implant. The surgeon

must be thoroughly knowledgeable not only in the medical and

surgical aspects of the implant, but also must be aware of the

mechanical and metallurgical aspects of the surgical implants.

19

1. Correct selection of the implant is extremely important.

The potential for success in fracture fixation is

increased by the selection of the proper type of implant.

While proper selection can help minimize risks, the size

and shape of human bones present limitations on the size

and strength of implants. Internal fixation devices cannot

withstand the activity levels and/or loads equal to those

placed on normal healthy bone. These devices are not

designed to withstand the unsupported stress of full weight

bearing, or load bearing.

2. The devices can break when subjected to increased loading

associated with nonunion or delayed union. Internal fixation

devices are load-sharing devices that hold a fracture in

alignment until healing occurs. If healing is delayed, or

does not occur, the implant can be expected to break,

bend or fail. Loads produced by weight bearing, and activity

levels may dictate the longevity of the implant.

3. Implant materials are subject to corrosion. Implanting

metals and alloys subjects them to constant changing

environments of salts, acids, and alkalis that can cause

corrosion. Putting dissimilar metals and alloys in contact

with each other can accelerate the corrosion process that

may enhance fracture of implants. Every effort should be

made to use compatible metals and alloys when marrying

them to a common goal, i.e., screws and plates.

4. Correct handling of implants is extremely important. Do not

modify implants. Do not notch or bend implants. Notches or

scratches put in the implant during the course of surgery

may contribute to breakage. Intraoperative fracture of

screws can occur if excessive force (torque) is applied

while seating bone screws.

5. Remove after fracture has healed. Implants can loosen,

fracture, corrode, migrate, or cause pain. If an implant remains

implanted after complete healing, the implant may cause

stress shielding, which may increase the risk of refracture in

an active patient. The surgeon should weigh the risks versus

benefits when deciding whether to remove the implant.

Adequate postoperative management to avoid refracture

should follow implant removal.

6. Adequately instruct the patient. Postoperative care is

important. The patient’s ability and willingness to follow

instruction is one of the most important aspects of

successful fracture management. Patients with senility,

mental illness, alcoholism, and drug abuse may be at

higher risk. These patients may ignore instructions and

activity restrictions. The patient is to be instructed in the

use of external supports, walking aids, and braces that

are intended to immobilize the fracture site and limit

weight bearing or load bearing. The patient is to be made

fully aware and warned that the device does not replace

normal healthy bone, and that the device can break, bend

or be damaged as a result of stress, activity, load bearing,

or weight bearing. The patient is to be made aware and

warned of general surgical risks, possible adverse effects,

and to follow the instructions of the treating physician.

The patient is to be advised of the need for regular

postoperative follow-up examination as long as the device

remains implanted.

7. In pediatric patients, care should be taken to avoid the

growth plate during plate/screw insertion.

8. Patient smoking may result in delayed healing, non-healing

and/or compromised stability in or around the placement site.

PRECAUTIONS

Device is single use only.

Do not reuse implants. While an implant may appear

undamaged, previous stress may have created imperfections

that would reduce the service life of the implant.

Do not treat patients with implants that have been even

momentarily placed in a different patient.

Instruments are available to aid in the accurate implantation of

internal fixation devices. Intraoperative fracture or breaking of

instruments has been reported.

Package Insert Information (Continued)

20

Surgical instruments are subject to wear with normal usage.

Instruments which have experienced extensive use or excessive

force are susceptible to fracture. Surgical instruments

should only be used for their intended purpose. Biomet

recommends that all instruments be regularly inspected for

wear and disfigurement.

All trial, packaging, and instrument components must be

removed prior to closing the surgical site. Do not implant.

POSSIBLE ADVERSE EFFECTS

1. Nonunion or delayed union, which may lead to breakage

of the implant.

2. Bending or fracture of the implant.

3. Loosening or migration of the implant.

4. Metal sensitivity, or allergic reaction to a foreign body.

5. Decrease in bone density due to stress shielding.

6. Pain, discomfort, or abnormal sensation due to the

presence of the device.

7. Nerve damage due to surgical trauma.

8. Necrosis of bone.

9. Postoperative bone fracture and pain.

10. Inadequate healing.

11. Early or late postoperative infection and/or

allergic reaction.

MAGNETIC RESONANCE (MR) STATEMENT

The effects of the MR environment have not been determined

for this device. This device has not been tested for heating or

migration in the MR environment.

STERILITY

The Forerunner Plating System is provided in both sterile and

non-sterile configurations.

1. The sterile system is provided sterile using a minimum

dosage of 2.5 megaRad (25 kGy) of gamma radiation. Where

specified, do not use implants after expiration date.

2. The non-sterile system must be sterilized prior to use. All

packaging materials must be removed prior to sterilization. All

components should be sterilized in a loosened state such that

components may move freely.

3. Re-sterilization of sterile products which have been opened is

permissible as long as the components have not been previously

implanted, not been exposed to biological contamination, nor

appear to have compromised mechanical integrity.

The following steam sterilization parameters are recommended:

Pre-Vacuum Steam Sterilization:

Temperature: 270°F (132°C)

Time: Eight (8) Minutes

Drying Time: Twenty (20) Minutes

NOTE: Allow for Cooling

Individuals or hospitals not using the recommended method,

temperature, and time are advised to validate any alternative

methods or cycles using an approved method or standard.

CAUTION: Federal law (USA) restricts this device to sale by or on

the order of a physician.

Comments regarding this device can be directed to Attn:

Regulatory Dept., Biomet Inc., P.O. Box 587, Warsaw, IN 46581

USA, FAX: 574-372-3968.

All trademarks herein are the property of Biomet, Inc. or its

subsidiaries unless otherwise indicated.

Further Information

21

This brochure describes a surgical technique used by Charles

Zelen, D.P.M. and Larry Didominico, D.P.M. Biomet Trauma

as the manufacturer of this device, does not recommend this

product or any specific surgical technique for use on any

individual patient. The surgeon who performs any implant

procedure is responsible for determining the appropriate

product(s) and utilizing the appropriate technique(s) for said

implantation in each individual patient. The contents of this

manual are intended to be only a guide and are not intended

to set a standard of care.

CAUTION: Federal Law (USA) restricts this device to sale

by or on the order of a physician.

For further information, please contact the Customer

Service Department at:

Biomet Trauma

56 East Bell Drive

P.O. Box 587

Warsaw, Indiana 46581-0587

800.348.9500 x 1501

www.biomet.com

22

Notes:

23

Notes:

24

Notes:

forerunner plating system - zimmer biometbiomet trauma, including screws, biomet® vision footring...

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