510(k) Report

Devices descending from K021621

7 later devices reach Fixed Bearing Uni Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.20171—
+1K042093Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc.200462
+2K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+2K122277Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford…Biomet Manufacturing Corp2012230
+2K050764Uniglide Unicondylar Knee ProsthesisCorin USA20052—
+3K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd.201414
+4K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—