| Device |
prosthesis, finger, semi-constrained, metal/polymer |
| Definition |
A Prosthesis, finger, semi-constrained, metal/polymer, is intended to replace the total first carpometacarpal joint to reduce pain and improve function when the native joint is compromised due to disease such as osteoarthritis. |
| Physical State |
The generic device type includes a stem that is implanted into the resected proximal first metacarpal bone, a modular head that is placed onto the stem, and a cup that is implanted into the resected trapezium. The head articulates with the cup to restore biomechanics of the native joint. |
| Technical Method |
The device replaces the native diseased joint between the distal trapezium and the proximal first metacarpal. |
| Target Area |
The first carpometacarpal (cmc) joint, located at the base of the thumb between the first metacarpal and the trapezium of the carpal bones. |
| Review Panel |
Orthopedic |
|---|
| Product Code | SFA |
|---|
| Premarket Review |
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
