510(k) Report

Devices descending from K111068

1 later device reach Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC20200—