510(k) Report

Devices descending from K061451

5 later devices reach Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC20200—
+1K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC20111—
+1K112278Ascension Nugrip CMC ImplantAscension Orthopedic20110—
+1K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc.20082—
+2K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC20091—