TOUCH® CMC 1 Prosthesis
FDA premarket approval P240020 · decided 2025-07-10
Approval details
- PMA number
- P240020
- Trade name
- TOUCH® CMC 1 Prosthesis
- Generic name
- Prosthesis, finger, semi-constrained, metal/polymer
- Applicant
- Keri Medical SA
- Date received
- 2024-06-07
- Decision date
- 2025-07-10
- Days to decision
- 398 days
- Decision code
- APPR
- Product code
- SFA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- 1228 Plan-Les-Ouates
- Statement
- TOUCH® CMC 1 Prosthesis is indicated for 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) in patients with symptomatic Eaton-Littler stage II or III osteoarthritis (OA).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| KeriFlex® MCP and PIP Finger Joint Prostheses (K211385) | Keri Medical SA | 2022-07-27 |