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What is CARTIVA® Synthetic Cartilage Implant (SCI)?

The first and only PMA Approved product for

The Treatment of First MTP joint Osteoarthritis

Premarket approval is the most stringent FDA approval process and is granted based on clinical evidence proving safety and effectiveness. CARTIVA® SCI PMA is the result of a 7 year research process.1

The only product of its kind backed by level 1 clinical evidence

CARTIVA® SCI is backed by Level 1 clinical evidence of safety and effectiveness, established in the largest prospective, randomized, multi-center study ever conducted for this painful condition.6 Level 1 clinical studies are the most rigorous and are based on large randomized controlled multi-center trials.7

BEST IN CLASS RESEARCH HIGHLIGHTS

  • First new articular surface material approved by FDA in 18 years1
  • Two-time recipient of the Roger A. Mann Award from the AOFAS, for the best clinical research in foot and ankle surgery6.8.9
  • The only device for treating hallux rigidus backed by Level 1 clinical research evidence proving safety and effectiveness6
  • Study data evaluated as low risk of bias in comprehensive published review10
  1. Premarket Approval (PMA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150017. Accessed on May 4, 2019.
  2. Baumhauer JF, Marcolongo M. The Science Behind Wear Testing for Great Toe Implants for Hallux Rigidus. Foot Ankle Clin. 2016 Dec; 21(4):891-902.
  3. 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 Biomater. 2012 Jul;100(5):1451-7.
  4. CARTIVA® Synthetic Cartilage Implant Instructions for Use (IFU).
  5. Data on file at Wright Medical.
  6. 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.
  7. Wright J, Swiontkowski M, Heckman J. Introducing Levels of Evidence to the Journal. J Bone Joint Surg Am. 2011 Jul;9(04):27-8.
  8. Baumhauer JF, Singh D, Glazebrook M, et al. Correlation of Hallux Rigidus Grade with Motion, Vas Pain, Intraoperative Cartilage Loss and Treatment Success for First MTP Joint Arthrodesis and Synthetic Cartilage Implant. Foot Ankle Int. 2017 Nov;38(11):1175-1182.
  9. Roger A. Mann Award. https://www.aofas.org/annual-meeting/program/awards/mann-award. Accessed on May 21, 2019.
  10. Stevens J, de Bot RT, Hermus JP, et al. Clinical Outcomes Following Total Joint Replacement and Arthrodesis for Hallux Rigidus: A Systematic Review. JBJS Rev. 2017 Nov;5(11):e2.