TOUCH® CMC 1 (Carpometacarpal) Prosthesis is a cementless, ball-and-socket dual-mobility, total CMC1 joint replacement prosthesis, designed to treat osteoarthritis of the base of the thumb. The TOUCH® CMC 1 Prosthesis was approved by FDA (P240020) on July 10, 2025. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post Approval Study Report per the requirements set forth in the approval.
