Identity
- Trade Name
- TOUCH® CMC 1 Prosthesis FDA PMA
- Generic Name
- Prosthesis, finger, semi-constrained, metal/polymer FDA PMA
Identifiers
- PMA Number
- P240020 FDA PMA
- FDA Product Code
- SFA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Touch CMC 1 Prosthesis is a semi-constrained metal and polymer finger joint prosthesis designed for orthopedic use. It is indicated for primary total joint replacement, or arthroplasty, of the first carpometacarpal joint in patients diagnosed with symptomatic Eaton-Littler stage II or III osteoarthritis.
This device is manufactured by Keri Medical SA and has received FDA PMA approval. It is intended for surgical implantation to address joint degeneration within the specified clinical parameters. Please consult the product labeling for specific surgical guidelines and regulatory information regarding its use.
Frequently asked questions
What is the Touch CMC 1 Prosthesis used for?
The device is indicated for primary total joint replacement of the first carpometacarpal joint in patients suffering from symptomatic Eaton-Littler stage II or III osteoarthritis.
What type of materials are used in this prosthesis?
The Touch CMC 1 Prosthesis is classified as a semi-constrained finger prosthesis constructed from a combination of metal and polymer components.
Has this device received regulatory approval?
Yes, the Touch CMC 1 Prosthesis has received FDA PMA approval, as indicated by the decision code APPR and the associated PMA number P240020.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TOUCH® Dual-Mobility CMC 1 Prosthesis - KeriMedical, TOUCH® CMC 1 New Enrollment US Study | ClinicalTrials.gov, Patient Information: TOUCH® CMC 1 Prosthesis - KeriMedical, Touch® CMC Prosthesis Cyprus | Dual-Mobility Thumb Implant, US Tips and Tricks - TOUCH® - CMC 1 Prosthesis - Vimeo
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | European Union | MDR | — | Class III | Pending data |
| FDA PMA | United States | FDA_PMA | P240020 | Class III | Active |
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Manufacturer
- Manufacturer
- Keri Medical SA
Sources (1)
- FDA PMA P240020 24 fields · synced Oct 6, 2026