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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, metatarsophalangeal joint cartilage replacement implant
Definition The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint.
Physical State The device is a molded cylindrical viscoelastic hydrogel implant composed of polyvinyl alcohol and saline.
Technical Method The device is placed into the metatarsal head in the first MTP joint via press-fit implantation. The viscoelastic hydrogel form and properties of the device are conducive to replacing focal areas of damaged cartilage, providing pain reduction, and maintaining range of motion. The device does not regrow or replace cartilage.
Target Area The device is implanted into the metatarsal head in the first MTP joint.
Review Panel Orthopedic
Product CodePNW
Premarket Review Stereotaxic, Trauma and Restorative Devices (DHT6C)
Stereotaxic, Trauma and Restorative Devices (DHT6C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible