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JWH

915 FDA 510(k) clearances · Product code

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RecordFirmDate
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM (K131019)Conformis, Inc.2013-05-24
PIPELINE KNEE SYSTEM (K123692)Pipeline Orthopedics2013-05-24
MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM (K130084)Tgm Medical, Inc.2013-05-03
NEO PS KNEE SYSTEM (K122500)Pipeline Orthopedics2013-05-03
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS (K123159)Smith & Nephew, Inc.2013-05-03
LOSPA TOTAL KNEE REPLACEMENT SYSTEM (K130673)Corentec Co., Ltd.2013-04-15
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING (K122239)Encore Medical L.P.2013-04-11
TK1 TOTAL KNEE SYSTEM (K123339)Novosource, Inc.2013-04-11
BALANCED KNEE SYSTEM HIGH FLEX PS (K123457)Ortho Development Corp.2013-03-22
OPTETRAK LOGIC POROUS FEMORAL COMPONENT (K123687)Exactech, Inc.2013-03-20
PERSONA NATURAL TIBIA BASEPLATES (K130143)Zimmer, Inc.2013-02-22
TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P (K123166)Howmedica Osteonics Corp.2013-02-14
AUGMENT AND SCREW, PSA TYPE (K122183)United Orthopedic Corp.2013-02-05
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122870)Conformis, Inc.2013-01-14
OPTETRAK LOGIC CRC TIBIAL INSERT (K123342)Exactech, Inc.2013-01-10
GKS PRIME FLEX CR TOTAL KNEE SYSTEM (K122975)Permedica2012-12-20
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122991)Conformis, Inc.2012-12-20
COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM (K120955)Aesculap Implant Systems, LLC2012-12-17
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM (K121640)Materialise NV2012-12-05
PERSONA NATURAL TIBIA BASEPLATES (K122765)Zimmer, Inc.2012-11-09
COLUMBUS REVISION KNEE SYSTEM (K122985)Aesculap Implant System, Inc.2012-10-26
GMK NARROW (K122232)Medacta International2012-09-28
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122033)Conformis, Inc.2012-09-27
UNITY TOATAL KNEE SYSTEM (K113060)Corin USA2012-09-10
JOURNEY II CR KNEE SYSTEM (K121443)Smith & Nephew, Inc.2012-08-13
VEGA KNEE SYSTEM (K121879)Aesculap Implant Systems2012-07-27
GMK SPHERE (K121416)Medacta International2012-07-20
DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE (K121835)Encore Medical L.P.2012-07-20
FREEDOM(R) STEMMED TIBIAL COMPONENTS (K111785)Maxx Orthopedics, Inc.2012-06-29
GMK - LINE EXTENSION (K120790)Medacta International2012-06-08
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ (K121307)Exactech, Inc.2012-05-31
GENESIS II PS NON-MODULAR FEMORAL COMPONENT (K120698)Smith & Nephew, Inc.2012-05-18
VANGUARD SSK 360 REVISION KNEE SYSTEM (K121149)Biomet Manufacturing Corp2012-05-16
UNITED U2 FEMORAL COMPONENT, PS, #7 (K120507)United Orthopedic Corporation2012-05-04
LOSPA TIBIAL BASE PLATE (K121037)Corentec Co., Ltd.2012-05-03
NEO CR KNEE SYSTEM (K120313)Pipeline Orthopedics2012-04-20
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K120316)Conformis, Inc.2012-04-19
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE (K113829)Materialise NV2012-04-02
ZIMMER PERSONA KNEE SYSTEM (K113369)Zimmer, Inc.2012-03-27
PIPELINE CR PRIMARY KNEE SYSTEM (K113122)Pipeline Orthopedics2012-03-20
VANGUARD COMPLETE KNEE SYSTEM (K113550)Biomet Manufacturing Corp2012-02-29
APEX REVISION KNEE SYSTEMS (K112891)Omni Life Science, Inc.2012-02-29
JOURNEY II DEEP DISHED ARTICULAR INSERTS (K113482)Smith & Nephew, Inc.2012-02-27
EAUM TOTAL KNEE SYSTEM (K110404)Corentec Co., Ltd.2012-02-16
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K113378)Conformis, Inc.2012-02-15
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) (K120068)Conformis, Inc.2012-02-03
KLASSIC KNEE SYSTEM (K112906)Total Joint Orthopedics, Inc.2012-02-01
GMK RESUFACING PATELLA SIZE 4 (K113571)Medacta International2012-01-27
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS (K112941)Smith & Nephew, Inc.2011-12-20
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K112780)Conformis, Inc.2011-12-15
EVOLUTION MP ADAPTIVE CS INSERT (K113325)Wrightmedicaltechnologyinc2011-12-09
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... (K112285)Tgm Medical, Inc.2011-11-04
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS (K111492)Materialise NV2011-10-13
JOURNEY II BCS KNEE SYSTEM (K111711)Smith & Nephew, Inc.2011-09-16
TRUMATCH PERSONALIZED SOLUTIONS (K110397)DePuy Orthopaedics, Inc.2011-08-16
UNITED U2 XPE TOTAL KNEE SYSTEM (K103733)United Orthopedic Corporation2011-08-02
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT (K111400)Exactech, Inc.2011-07-28
APEX KNEE SYSTEM, APEX ALL POLY TIBIA (K111062)Omni Life Science, Inc.2011-07-13
APEX PS KNEE SYSTEM - PS-C INSERT (K111184)Omni Life Science, Inc.2011-06-22
GMK REVISION HYBRID LINERS (K111283)Medacta International2011-05-27
HLS KNEETEC SYSTEM (K094013)Tornier2011-05-05
REVISION PROTHESIS (K110837)Smith & Nephew, Inc.2011-04-22
OPTERTRAK LOGIC PSC TIBIAL INSERT (K110547)Exactech Sarasota2011-04-14
APEX PS KNEE SYSTEM (K102578)Omni Life Science, Inc.2011-03-25
GMK REVISION KNEE SC LINERS (K103170)Medacta International S.A.2011-03-24
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA (K103837)Ortho Development2011-03-24
SYMMETRIC TOTAL KNEE AGUMENTS (K100370)Signal Medical Corp.2011-03-07
VANGUARD REMOVABLE MOLDED POLY TIBIA (K102580)Biomet Manufacturing Corp2011-03-03
VANGUARD ASYMMETRICAL PATELLAR COMPONENT (K110362)Biomet Manufacturing Corp2011-02-28
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS (K102125)Biomet, Inc.2011-02-23
SIGNATURE PLANNER; SIGNATURE GUIDES (K102795)Materialise NV2011-02-02
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K103117)Conformis, Inc.2011-01-07
EVOLUTION MP TOTAL KNEE SYSTEM (K102380)Wrightmedicaltechnologyinc2011-01-07
OPTIGEN TOTAL KNEE SYSTEM (K102367)U&I Corp.2010-12-08
VANGUARD 360 REVISION KNEE SYSTEM (K093293)Biomet, Inc.2010-10-22
DEPUY UNIVERSAL GRIPTION TF CONES (K100391)DePuy Orthopaedics, Inc.2010-09-29
APEX KNEE MODULAR TIBIA SYSTEM (K101994)Omnlife Science2010-09-28
GMK REVISION KNEE SYSTEM (K102437)Medacta International S.A.2010-09-24
ITOTAL CR KNEE REPLACEMENT SYSTEM (K094050)Conformis, Inc.2010-09-16
JOURNEY CR KNEE SYSTEM (K101499)Smith & Nephew, Inc.2010-08-26
OPTETRAK LOGIC COMBINATION TIBIAL TRAY (K101981)Exactech, Inc.2010-08-02
VEGA KNEE SYSTEM (K101281)Aesculap Implant System, Inc.2010-07-30
CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX (K101032)Cardo Medical, Inc.2010-07-08
CONSENSUS REVISION KNEE SYSTEM (K100542)Consensus Orthopedics, Inc.2010-06-24
MOTIVATION KNEE SYSTEM (K100900)Encore Medical L.P.2010-06-18
UNITED STEM, PSA TYPE (K100981)United Orthopedic Corp.2010-06-14
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM (K093746)Smith & Nephew, Inc.2010-04-14
MYKNEE CUTTING BLOCKS (K093806)Medacta International S.A.2010-04-08
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 (K094017)Omni Life Science, Inc.2010-03-05
EVOLUTION MP TOTAL KNEE SYSTEM (K093552)Wrightmedicaltechnologyinc2010-03-04
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM (K093567)Anova Implant Solutions, LLC2010-02-05
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T (K093360)Exactech, Inc.2010-01-11
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT (K092803)Cardo Medical Corp.2009-12-23
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) (K091263)Materialise NV2009-11-19
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT (K090705)Ortho Development Corp.2009-10-09
JOURNEY BCS KNEE SYSTEM (K091014)Smith & Nephew, Inc.2009-09-29
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT (K091280)Maxx Orthopedics, Inc.2009-09-25
ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE (K092201)Wrightmedicaltechnologyinc2009-08-20
GMK TOTAL KNEE SYSTEM (K090988)Medacta International S.A.2009-07-10
COLUMBUS REVISION KNEE SYSTEM (K083772)Aesculap Implant System, Inc.2009-06-04
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