510(k) Report

Devices descending from K051640

38 later devices reach U2 Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+1K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+1K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+1K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+1K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+1K142649Progressive Orthopedic Total Knee SystemThe Progressive Orthopaedic Company, LLC201510—
+1K140073U2 Femoral Component, CR, CementedUnited Orthopedic Corp.20144—
+1K140075U2 Femoral Component, CR, Porous CoatedUnited Orthopedic Corp.20143—
+1K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+1K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+1K131398Novoknee Total Knee SystemNovosource, Inc.201310—
+1K123339TK1 Total Knee SystemNovosource, Inc.201311—
+1K120507United U2 Femoral Component, PS, #7United Orthopedic Corporation201241
+1K103733United U2 Xpe Total Knee SystemUnited Orthopedic Corporation201182
+1K082424United U2 Total Knee SystemUnited Orthopedic Corp.2008152
+1K082469United U2 PatellaUnited Orthopedic Corp.20080—
+2K261032NovoKnee (SteriKnee)NovoSource20260—
+2K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation20250—
+2K242410NextStep Arthropedix Total Knee SystemNextstep Arthropedix20250—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+2K221705U2 Total Knee System-PF+United Orthopedic Corporation20231—
+2K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210—
+2K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+2K190100USTAR II SystemUnited Orthopedic Corporation201925
+2K190355Precision Casting Solutions Total Knee SystemPrecision Casting Solutions, Inc.20190—
+2K183344The Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLC20190—
+2K183225Stabil Orthopaedic Solutions Total Knee SystemStabil Orthopaedic Solutions, LLC20190—
+2K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+2K181146ASK SystemL and K Biomed Corporation Limited20180—
+2K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+2K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+2K150832U2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic Corporation20152—
+2K150783Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC20158—
+2K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+2K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.201310—
+2K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+3K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+3K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—