510(k) Report

Devices descending from K030319

3 later devices reach Orthosphere Ceramic Spherical Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC20091—
+1K060560Ascension Pyrosphere CMC/TMTAscension Orthopedics, Inc.200601
+2K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC20200—