ClearanceBrief
Panels › Orthopedic › Product code JWH · Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Regulation 888.3560

14510(k)s in 12 months (921 all time)
6recalls in 12 months (984 all time)
887recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
Decided510(k)Device and applicantCode
Feb 15, 2012K113378CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Conformis, Inc.
JWH
Feb 3, 2012K120068CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
Conformis, Inc.
JWH
Feb 1, 2012K112906KLASSIC KNEE SYSTEM
Total Joint Orthopedics, Inc.
JWH
Jan 27, 2012K113571GMK RESUFACING PATELLA SIZE 4
Medacta International
JWH
Dec 20, 2011K112941LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS
Smith & Nephew, Inc.
JWH
Dec 15, 2011K112780CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Conformis, Inc.
JWH
Dec 9, 2011K113325EVOLUTION MP ADAPTIVE CS INSERT
Wrightmedicaltechnologyinc
JWH
Nov 4, 2011K112285MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...
Tgm Medical, Inc.
JWH
Oct 13, 2011K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
Materialise NV, BE
JWH
Sep 16, 2011K111711JOURNEY II BCS KNEE SYSTEM
Smith & Nephew, Inc.
JWH
Aug 16, 2011K110397TRUMATCH PERSONALIZED SOLUTIONS
DePuy Orthopaedics, Inc.
JWH
Aug 2, 2011K103733UNITED U2 XPE TOTAL KNEE SYSTEM
United Orthopedic Corporation, TW
JWH
Jul 28, 2011K111400OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
Exactech, Inc.
JWH
Jul 13, 2011K111062APEX KNEE SYSTEM, APEX ALL POLY TIBIA
Omni Life Science, Inc.
JWH
Jun 22, 2011K111184APEX PS KNEE SYSTEM - PS-C INSERT
Omni Life Science, Inc.
JWH
May 27, 2011K111283GMK REVISION HYBRID LINERS
Medacta International
JWH
May 5, 2011K094013HLS KNEETEC SYSTEM
Tornier, FR
JWH
Apr 22, 2011K110837REVISION PROTHESIS
Smith & Nephew, Inc.
JWH
Apr 14, 2011K110547OPTERTRAK LOGIC PSC TIBIAL INSERT
Exactech Sarasota
JWH
Mar 25, 2011K102578APEX PS KNEE SYSTEM
Omni Life Science, Inc.
JWH
Mar 24, 2011K103837BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
Ortho Development
JWH
Mar 24, 2011K103170GMK REVISION KNEE SC LINERS
Medacta International S.A.
JWH
Mar 7, 2011K100370SYMMETRIC TOTAL KNEE AGUMENTS
Signal Medical Corp.
JWH
Mar 3, 2011K102580VANGUARD REMOVABLE MOLDED POLY TIBIA
Biomet Manufacturing Corp
JWH
Feb 28, 2011K110362VANGUARD ASYMMETRICAL PATELLAR COMPONENT
Biomet Manufacturing Corp
JWH
Feb 23, 2011K102125PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
Biomet, Inc.
JWH
Feb 2, 2011K102795SIGNATURE PLANNER; SIGNATURE GUIDES
Materialise NV, BE
JWH
Jan 7, 2011K103117ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
Conformis, Inc.
JWH
Jan 7, 2011K102380EVOLUTION MP TOTAL KNEE SYSTEM
Wrightmedicaltechnologyinc
JWH
Dec 8, 2010K102367OPTIGEN TOTAL KNEE SYSTEM
U&I Corp., KR
JWH
Oct 22, 2010K093293VANGUARD 360 REVISION KNEE SYSTEM
Biomet, Inc.
JWH
Sep 29, 2010K100391DEPUY UNIVERSAL GRIPTION TF CONES
DePuy Orthopaedics, Inc.
JWH
Sep 28, 2010K101994APEX KNEE MODULAR TIBIA SYSTEM
Omnlife Science
JWH
Sep 24, 2010K102437GMK REVISION KNEE SYSTEM
Medacta International S.A.
JWH
Sep 16, 2010K094050ITOTAL CR KNEE REPLACEMENT SYSTEM
Conformis, Inc.
JWH
Aug 26, 2010K101499JOURNEY CR KNEE SYSTEM
Smith & Nephew, Inc.
JWH
Aug 2, 2010K101981OPTETRAK LOGIC COMBINATION TIBIAL TRAY
Exactech, Inc.
JWH
Jul 30, 2010K101281VEGA KNEE SYSTEM
Aesculap Implant System, Inc.
JWH
Jul 8, 2010K101032CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX
Cardo Medical, Inc.
JWH
Jun 24, 2010K100542CONSENSUS REVISION KNEE SYSTEM
Consensus Orthopedics, Inc.
JWH
Jun 18, 2010K100900MOTIVATION KNEE SYSTEM
Encore Medical L.P.
JWH
Jun 14, 2010K100981UNITED STEM, PSA TYPE
United Orthopedic Corp., TW
JWH
Apr 14, 2010K093746VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
Smith & Nephew, Inc.
JWH
Apr 8, 2010K093806MYKNEE CUTTING BLOCKS
Medacta International S.A.
JWH
Mar 5, 2010K094017TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
Omni Life Science, Inc.
JWH
Mar 4, 2010K093552EVOLUTION MP TOTAL KNEE SYSTEM
Wrightmedicaltechnologyinc
JWH
Feb 5, 2010K093567ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
Anova Implant Solutions, LLC
JWH
Jan 11, 2010K093360OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
Exactech, Inc.
JWH
Dec 23, 2009K092803CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
Cardo Medical Corp.
JWH
Nov 19, 2009K091263ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)
Materialise NV, BE
JWH

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