510(k) Report

Devices descending from K960534

2 later devices reach Metallic Spherical CMC Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC20091—
+2K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC20200—