EXPERIENCE THE CARTIVA® SYNTHETIC CARTILAGE IMPLANT (SCI) DIFFERENCE

F O O T | First MTP Joint

L O W E R E X T R E M I T I E SCARTIVA®

Synthetic Cartilage Implant

UNLIKE FUSION, CARTIVA® SCI HELPS REDUCE PAIN WHILE PRESERVING MOTION OF THE FIRST MTP JOINT FOR PATIENTS WITH OSTEOARTHRITIS1,2

• An innovative, motion-preserving alternative to first MTP joint fusion1

• Proven through rigorous clinical study and evaluation

– Best-in-class, Level 1 clinical research evidence demonstrates effectiveness and safety in the largest and longest prospective, randomized, multi-center study of its kind1,2

– Met FDA’s rigorous standards for premarket approval of an orthopedic device or implant3

– 1st and only FDA-approved synthetic cartilage-like implant to treat the pain of hallux rigidus3

• 93% of patients* said they would undergo surgery with CARTIVA® SCI again2

*Surveyed at 5.8 years post-surgery

T H E D I F F E R E N C E I S D ATA .™ From the leaders in foot and ankle

SHORT-TERM RESULTS WITH CARTIVA® SYNTHETIC CARTILAGE IMPLANT (SCI)1

Patients may experience:

• Significantly less pain as soon as 2 weeks post-surgery

• Significantly improved foot and ankle function as soon as 3 months post-surgery

LONG-TERM RESULTS: 5.8 YEARS OUTCOMES WITH CARTIVA® SCI

-97% +176% 93%

REDUCTION IN PAIN4,5

Based on patient reported outcomes using the Visual Analog Scale for Pain

PATIENT SATISFACTION2

93% of patients said they would undergo the CARTIVA® implant

surgery again

IMPROVEMENT IN FUNCTION4,5

Based on patient reported outcomes using the validated Foot and Ankle

Ability Measure (FAAM) Sports score

LONG-LASTING PAIN REDUCTION AND MOBILITY*

Substantial Pain Reduction2,4 N = 106

Med

ian

VAS

Pain

[mm

]

70

60

50

40

30

20

10

0Pre-op 1 Year6 Mths 2 Years

67

28

42

6

21

13

23

5.8 Years

Post-Approval Study Cohort

Substantial Functional Improvement2,4

63

Med

ian

FAA

M S

ports

Sco

re

100

90

80

70

60

50

40

30

20

10

0Pre-op 1 Year6 Mths 5.8 Years2 Years

34 35

919488

75

16

91

Post-Approval Study Cohort

N = 105

CARTIVA® SCI—the first and only FDA-approved implant of its kind—is uniquely engineered to preserve current first MTP joint motion and reduce hallux rigidus pain so patients can enjoy improved mobility.*1-3

WHO ARE GOOD CANDIDATES FOR CARTIVA® SCI?CARTIVA® SCI is an excellent option for patients with big toe arthritis with good alignment of the toe, who wish to retain first MTP joint motion and obtain substantial pain reduction and improved function.7 • Patients with Grades 2 to 4 hallux rigidus are most viable8

• Early surgical correction may help prevent further limitation of joint motion9

*Mobility measured using patient reported outcomes from the Foot and Ankle Measure (FAAM) Sports score

For a list of indications and contraindications for CARTIVA® SCI, see the back panel.

The CARTIVA® SCI Patient Identification Tool is a convenient, pocket-sized resource to help recognize appropriate patients during consultations

WHAT IS CARTIVA® SYNTHETIC CARTILAGE IMPLANT (SCI)?

For your patients with first MTP joint osteoarthritis, CARTIVA® SCI can help reduce pain and improve foot function.1 This reusable, pocket-size tool can help you quickly and easily identify appropriate candidates for the innovative, cartilage-like polymer.2

CARTIVA® SCI is designed for patients with all of the following:

3 Painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus3

3 Grade 2, 3 or 4 hallux rigidus, according to the Clinical-Radiographic System for Grading3,4

3 Current motion of the great toe1 (since CARTIVA® SCI preserves existing motion)

3 Good alignment of the great toe5

Rely on the CARTIVA® SCI Difference

3 Short- and long-term pain reduction2,6

3 Mimics natural cartilage to preserve first MTP joint motion1,2

3 Improves sports- and daily-activity-related foot function1

3 High patient satisfaction: 93% would get CARTIVA® SCI again6*

PATIENT IDENTIFICATION TOOLC A R T I VA ® S Y N T H E T I C C A R T I L A G E I M P L A N T

*At 5.8 years.

Please see contraindications on reverse.

Made of rigorously tested proprietary biomaterial with properties that mimic human cartilage5,6

• Compressible

• Durable

• Biocompatible

• Low co-efficient of friction

Now optimized for increased efficiencies

• New drill bit with two options that enable you to place the implant proud at ~0.5-1.5 mm or ~1.5-2.5 mm

• Next-generation instrumentation available in convenient, single-use kits

CARTIVA®

Synthetic Cartilage Implant

EARLY MOTION-PRESERVING BENEFITS THAT FUSION CAN’T PROVIDE1,2,4,10

HELPING YOUR PATIENTS UNDERSTAND WHAT TO EXPECT WITH CARTIVA® SCI

CARTIVA® SCI VS. FUSION

Pain reduction

• Patients may experience significant pain reduction as soon as 2 weeks post-surgery. As with any motion-preserving orthopedic procedure, there will be some residual pain that improves over time1,7

• More complete pain reduction takes 3-6 months1,7

Toe motion

• The ability to bend the toe generally returns to baseline within 2 weeks and continues to improve over the next 2 years post-surgery1,7

Foot mobility (sports-related)

• Patients generally return to baseline foot function* by week 6 (mean) and continue to improve through year 21

• Patients are advised not to return to fast walking, running, hopping, or toe-impact exercises (eg, soccer) for 3 months post-surgery. After this, return to activity should be gradual and always with a shoe, not a bare foot7

Healing & recovery7

• Even though patients resume wearing their normal shoes, this does not mean that healing is complete

• Patients should be given range-of-motion exercises for home or might have formal physical therapy if requested

• Overall, it can take 6 to 12 months for optimal recovery

Advantages for patients with CARTIVA® SCI vs fusion10

• Faster return to activities

• Ability to bear weight immediately

• No cast or boot

• Less restrictive rehab protocol

The CARTIVA® SCI Recovery Guide is a comprehensive resource to help patients better understand and follow rehabilitation protocol after surgery

CONSIDER CARTIVA® SCI to help preserve patients’ MTP joint motion and substantially reduce their hallux rigidus pain1,2

CARTIVA® SCI DOES NOT BURN BRIDGESSURGERY WITH CARTIVA® SCI DOES NOT PRECLUDE THE OPTION OF FUTURE FUSION, SHOULD IT BE NEEDED11

40% FASTERPROCEDURE TIME THAN FUSION10

CARTIVA

Fusion

What to expect after receiving CARTIVA® Synthetic Cartilage Implant (SCI) for big toe arthritis

TIME TO RECOVER

CARTIVA® SCI—the first and only FDA-approved implant of its kind—is uniquely engineered to preserve current first MTP joint motion and reduce hallux rigidus pain so patients can enjoy improved mobility.*1-3

WHO ARE GOOD CANDIDATES FOR CARTIVA® SCI?CARTIVA® SCI is an excellent option for patients with big toe arthritis with good alignment of the toe, who wish to retain first MTP joint motion and obtain substantial pain reduction and improved function.7

• Patients with Grades 2 to 4 hallux rigidus are most viable8

• Early surgical correction may help prevent further limitation of joint motion9

*Mobility measured using patient reported outcomes from the Foot and Ankle Measure (FAAM) Sports score* Mobility measured using patient reported outcomes from the Foot and Ankle Measure (FAAM) Sports score

For a list of indications and contraindications for CARTIVA® SCI, see the back panel.

WHAT IS CARTIVA® SYNTHETIC CARTILAGE IMPLANT (SCI)?

Made of rigorously tested proprietary biomaterial with properties that mimic human cartilage5,6

• Compressible

• Durable

• Biocompatible

• Low co-efficient of friction

Now optimized for increased efficiencies

• New drill bit with two options that enable you to place the implant proud at ~0.5-1.5 mm or ~1.5-2.5 mm

• Next-generation instrumentation available in convenient, single-use kits

MOTION-PRESERVING, PAIN-REDUCING, MOBILITY-ENHANCING* INNOVATION FROM WRIGHT MEDICAL1,2

CARTIVA®

Synthetic Cartilage Implant

The CARTIVA® SCI Patient Identification Tool is a convenient, pocket-sized resource to help recognize appropriate patients during consultations

For your patients with first MTP joint osteoarthritis, CARTIVA® SCI can help reduce pain and improve foot function.1 This reusable, pocket-size tool can help you quickly and easily identify appropriate candidates for the innovative, cartilage-like polymer.2

CARTIVA® SCI is designed for patients with all of the following:

3 Painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus3

3 Grade 2, 3 or 4 hallux rigidus, according to the Clinical-Radiographic System for Grading3,4

3 Current motion of the great toe1 (since CARTIVA® SCI preserves existing motion)

3 Good alignment of the great toe5

Rely on the CARTIVA® SCI Difference

3 Short- and long-term pain reduction2,6

3 Mimics natural cartilage to preserve first MTP joint motion1,2

3 Improves sports- and daily-activity-related foot function1

3 High patient satisfaction: 93% would get CARTIVA® SCI again6*

PATIENT IDENTIFICATION TOOLC A R T I VA ® S Y N T H E T I C C A R T I L A G E I M P L A N T

*At 5.8 years.

Please see contraindications on reverse.

Procedural advantages with CARTIVA® SCI vs fusion

THE CARTIVA® SCI DIFFERENCE: INTRA-OPERATIVE BENEFITS10

CARTIVA® SCIFirst MTP

joint fusion (arthrodesis)

nominal p-value*

40% less procedure time (avg)

Operative time (mean ± SD, in minutes)

[N=112]35 ± 12.3

[N=39]58 ± 21.5 p<0.001

30% minutes less anesthesia time (avg)

Duration of anesthesia (mean ± SD, in minutes)

[N=137]67 ± 27.8

[N=44]95 ± 41.1 p<0.001

*p-value is not adjusted for multiple comparisons

THE CARTIVA® SCI DIFFERENCE: RECOVERY PERIOD BENEFITS10

FASTER RETURN TO BASELINE LEVEL OF ACTIVITY10

Percent of Normal Sports Function12 (mean + SD)

CARTIVA® SCI First MTP joint fusion (arthrodesis)

nominal p-value*

Baseline [N=129]60.9% ± 20.7

[N=49]59.4% ± 22.2

Week 6 [N=127]67.3% ± 20.6

[N=48]53.4% ± 26.4 p<0.002

*p-value is not adjusted for multiple comparisons

1. Baumhauer JF, Singh D, Glazebrook M, et al. Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus. Foot Ankle Int. 2016;37(5):457-469. 2. Glazebrook M, Blundell CM, O’Dowd D, et al. Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int. 2019;40(4):374-383. 3. Premarket Approval (PMA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150017. Accessed on May 4, 2019. 4. Wright Medical. Data on file. Wright Medical Group N.V. Memphis, TN. In N=106 in post-approval study cohort. 5. Baker MI, Walsh SP, Schwartz Z, Boyan BD. A review of polyvinyl alcohol and its uses in cartilage and orthopedic applications. J Biomed Mater Res B Appl Biomaterials. 2012;100(5):1451-1457. 6. Baumhauer JF, Marcolongo M. The Science Behind Wear Testing for Great Toe Implants for Hallux Rigidus. Foot Ankle Clin. 2016; 21(4):891-902. 7. Baumhauer JF, Daniels T, Glazebrook M. New Technology in the Treatment of Hallux Rigidus with a Synthetic Cartilage Implant Hemiarthroplasty. Ortho Clin N Am. 2019;50:109-118. 8. Cartiva Synthetic Cartilage Implant [instructions for use]. 9. Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003;85-A(11):2072-2088. 10. Glazebrook MA, Younger ASE, Daniels TR, et al. Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time. Foot Ankle Surg. 2018 Oct;24(5):440-447. 11. Glazebrook M, Baumhauer J, Davies MB. Revision of Implant to Great Toe Fusion: Did We “Burn a Bridge” With a Synthetic Implant Hemiarthroplasty? Foot & Ankle Orthopaedics. 2017;2(3):2473011417S000044. 12. Patients were queried, “How would you rate your current level of function during your sports related activities from 0 to 100 with 100 being your level of function prior to your foot or ankle problem and 0 being the inability to perform any of your usual daily activities?”

Wright Medical 6120 Windward Parkway, Suite 220Alpharetta, GA 30005 USATel: +1 (770) 754-3800 CARTIVA.netinfo@cartiva.net

™ and ® denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates. © 2019 Wright Medical Group N.V. or its affiliates. All rights reserved. AP-012489A_22-Aug-2019

INDICATIONS

The CARTIVA® Synthetic Cartilage Implant is intended for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus, defined as a hallux valgus angle less than or equal to 20º (greater than 20º was an exclusion criteria in the clinical study).

CONTRAINDICATIONS

The CARTIVA® SCI should not be implanted in subjects with the following conditions:

• Active infection of the foot

• Known allergy to polyvinyl alcohol

• Inadequate bone stock due to significant bone loss, avascular necrosis, and/or largeosteochondral cyst (> 1 cm) of the metatarsophalangeal joint

• Lesions of the first metatarsal head greater than 10 mm in size

• Diagnosis of gout with tophi

• Physical conditions that would tend to eliminate adequate implant support (e.g.,insufficient quality or quantity of bone resulting from cancer, congenital dislocation,or osteoporosis), systemic and metabolic disorders leading to progressive deteriorationof bone (e.g., cortisone therapies or immunosuppressive therapies), and/or tumorsof the supporting bone structures

PRECAUTIONS

The safety and effectiveness of this device has not been established in subjects with the following conditions:

• Pediatric patients (< 22 years of age)

• Subjects with osteonecrosis of the first metatarsophalangeal joint

• Osteoarthritis involving the first metatarsophalangeal joint with grade 0 or 1hallux rigidus per the Coughlin Scale9 [Coughlin 2003/ p 2073/ Table 1]

The safety and effectiveness of the CARTIVA® SCI device for treatment in the presence of hallux varus to any degree or hallux valgus >20° is unknown.

The safety and effectiveness of using more than one CARTIVA® SCI device per joint is unknown.

The safety and effectiveness of the CARTIVA® SCI device at anatomic locations other than the first metatarsophalangeal joint is unknown.

The CARTIVA® SCI device should only be used by experienced surgeons who have undergone training in the use of this device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events.

Examine all instruments prior to surgery for wear or damage. Replace any worn or damaged instruments.

Use aseptic technique when removing the CARTIVA® SCI device from the innermost packaging.

Carefully inspect the device and its packaging for any signs of damage, including damage to the sterile barrier. Do not use CARTIVA® SCI devices if the packaging is damaged or the implant shows signs of damage.

Use care when handling the CARTIVA® SCI device to ensure that it does not come in contact with objects that could damage the implant. Damaged implants are no longer functionally reliable.

The CARTIVA® SCI device should not be used with components or instruments from other manufacturers.

CARTIVA® SCI device should not be re-used or re-implanted. Ensure proper alignment and placement of device components as misalignment may cause excessive wear and/or early failure of the device.

BRIEF SUMMARY OF IMPORTANT PRODUCT INFORMATION

Cartiva® is not right for everyone and only your doctor can determine whether Cartiva® is right for you. Speak to your doctor to see if Cartiva® is right for you. Individual results and activity levels after surgery vary and depend on many factors including age, weight and prior activity level and your results and activity levels may not be the same as those referenced in this brochure. There are risks and recovery times associated with any surgery and there are certain individuals who should not undergo surgery. Only your doctor can tell you if Cartiva® and the associated procedure are right for you and your unique circumstances. Please consult with your doctor for complete information regarding benefits, risks, anticipated implant duration and possible outcomes.