510(k) Report

Devices descending from K010212

24 later devices reach Offset Tibial Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+1K142933Biomet Tibial traysBiomet, Inc.201463
+1K103837Balanced Knee System Revision Offset TibiaOrtho Development20110—
+1K093293Vanguard 360 Revision Knee SystemBiomet, Inc.2010215
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K143192Vanguard 360 Revision Knee SystemBiomet, Inc.20150—
+2K140883Vanguard 360 Osseoti Tibial Sleeve AugmentBiomet, Inc.20140—
+2K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+2K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.201310—
+2K121149Vanguard SSK 360 Revision Knee SystemBiomet Manufacturing Corp20127—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+5K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—