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 Code | PNW |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |