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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTOUCH® CMC 1 Prosthesis
Generic NameProsthesis, finger, semi-constrained, metal/polymer
ApplicantKeri Medical SA
Chemin Du Pre-Fleuri 5
1228 Plan-Les-Ouates 
PMA NumberP240020
Date Received06/07/2024
Decision Date07/10/2025
Product Code SFA 
Docket Number 25M-2274
Notice Date 07/11/2025
Advisory Committee Orthopedic
Clinical TrialsNCT01954433
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 
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