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JWH

915 FDA 510(k) clearances · Product code

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RecordFirmDate
FREEDOM METAL BACKED TIBIAL COMPONENT (K090411)Maxx Orthopedics, Inc.2009-04-07
FANNING-PAPPAS MODULAR KNEE BEARING (K081400)Endotec, Inc.2009-02-20
FREEDOM TOTAL KNEE SYSTEM (K082019)Maxx Orthopedics, Inc.2009-02-06
UNITED U2 TOTAL KNEE SYSTEM (K082424)United Orthopedic Corp.2008-12-16
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY (K082358)Smith & Nephew, Inc.2008-11-25
DEPUY SIGMA CR-F FEMORAL COMPONENT (K082500)DePuy Orthopaedics, Inc.2008-11-18
VANGUARD CR STEM HOUSINGS (K082826)Biomet Manufacturing Corp2008-10-24
EVOLIS TOTAL KNEE SYSTEM (K081023)Medacta International S.A.2008-10-22
ACCIN TOTAL KNEE SYSTEM (K081127)Accelerated Innovation, LLC2008-10-17
UNITED U2 PATELLA (K082469)United Orthopedic Corp.2008-09-26
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ (K082022)Exactech, Inc.2008-09-02
SYMMETRIC TOTAL KNEE SYSTEM (K080199)Signal Medical Corporation2008-07-03
E-POLY TIBIAL BEARINGS (K080528)Biomet Orthopedics, Inc.2008-06-17
PROVEN STEM EXTENDER (K081458)Stelkast Company2008-06-06
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 (K062274)Tecres S.P.A.2008-05-22
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS (K080936)Conformis, Inc.2008-05-12
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS (K080204)Biomet, Inc.2008-03-20
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K073286)Zimmer, Inc.2008-03-07
MODIFICATION TO: APEX KNEE SYSTEM (K073602)Omnlife Science2008-02-14
DEPUY SIGMA PS FEMORAL COMPONENTS (K073529)DePuy Orthopaedics, Inc.2008-01-24
DEPUY LPS DISTAL FEMORAL COMPONENT (K063686)DePuy Orthopaedics, Inc.2007-12-20
LEGION STEM WITH HOLES (K072531)Smith & Nephew, Inc.2007-12-06
TC-PLUS PRIMARY KNEE SYSTEM (K072858)Smith & Nephew, Inc.2007-11-20
REGENEREX POROUS TITANIUM SLEEVE AUGMENTS (K072336)Biomet Manufacturing Corp2007-11-05
MODIFICATION TO TRIATHLON TS KNEE SYSTEM (K072221)Howmedica Osteonics Corp.2007-10-15
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS (K071071)Smith & Nephew, Inc.2007-09-19
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY (K071499)Aesculap Implant Systems, Inc.2007-09-14
NEXGEN PROLONG ALL-POLY PATELLA (K072281)Zimmer, Inc.2007-09-06
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) (K070981)Aesculap Implant Systems, Inc.2007-08-21
MODIFICATION TO SCORPIO NRG KNEE SYSTEM (K071991)Howmedica Osteonics Corp.2007-08-15
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER (K071738)Exactech, Inc.2007-08-15
TRIATHLON TS KNEE SYSTEM (K070095)Howmedica Osteonics Corp.2007-06-01
COLUMBUS TOTAL KNEE SYSTEM AS (K071220)Aesculap Implant Systems, Inc.2007-06-01
DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES (K063633)DePuy Orthopaedics, Inc.2007-03-02
TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT (K063423)Howmedica Osteonics2007-01-22
MICROPLASTY TIBIAL TRAYS (K063732)Biomet Manufacturing Corp2007-01-18
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT (K063211)Stelkast Company2007-01-18
ENCORE KNEE SYSTEM IFU (K063406)Encore Medical L.P.2007-01-08
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL (K062768)Zimmer, Inc.2006-10-13
23 MM SINGLE-PEG PATELLA COMPONENT (K061340)Biomet Manufacturing, Inc.2006-09-25
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM (K052687)Conformis, Inc.2006-08-31
TRIATHLON LOW PROFILE TIBIAL TRAY (K062037)Howmedica Osteonics Corp.2006-08-03
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES (K061882)Zimmer, Inc.2006-08-01
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM (K060569)Ortho Development Corp.2006-07-06
APEX KNEE SYSTEM (K060192)Omni Life Science, Inc.2006-06-15
NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT (K060722)Zimmer, Inc.2006-05-26
VANGUARD REMOVABLE MOLDED POLY TIBIA (K060525)Biomet Manufacturing Corp2006-05-25
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE (K053579)Aesculap, Inc.2006-05-17
LEGION COBALT CHROME REVISION KNEE SYSTEM (K060742)Smith & Nephew, Inc.2006-05-03
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS (K060370)Zimmer, Inc.2006-04-28
DEPUY PFC SIGMA KNEE PROSTHESIS (K060515)DePuy Orthopaedics, Inc.2006-03-23
U2 TOTAL KNEE SYSTEM (K051640)United Orthopedic Corp.2006-03-01
COLUMBUS (CR) TOTAL KNEE SYSTEM (K053390)Aesculap, Inc.2006-02-06
TRIATHLON TOTAL KNEE SYSTEM (K053514)Stryker Orthopaedics2006-01-26
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS (K052879)Zimmer, Inc.2005-11-22
PROVEN REVISION MODULAR TIBIAL TRAY (K051976)Stelkast Company2005-10-17
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS (K051977)Howmedica Osteonics Corp.2005-10-12
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ (K051756)Zimmer Trabecular2005-07-27
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT (K051229)Smith & Nephew, Inc.2005-07-20
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES (K050210)Biomet, Inc.2005-07-19
TRIATHLON KNEE SYSTEM (K051146)Howmedica Osteonics Corp.2005-07-13
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS (K050723)Zimmer, Inc.2005-04-20
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT (K050539)Howmedica Osteonics Corp.2005-03-29
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE (K042515)Smith & Nephew, Inc.2005-03-14
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT (K041825)Smith & Nephew, Inc.2005-03-11
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS (K043101)Zimmer, Inc.2005-03-07
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM (K043440)Smith & Nephew, Inc.2005-02-18
VANGUARD SSK KNEE SYSTEM (K042757)Biomet, Inc.2005-02-11
SCORPIO NRG KNEE SYSTEM (K042343)Howmedica Osteonics Corp.2005-02-09
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT (K042993)Howmedica Osteonics Corp.2005-01-12
AEQUOS (K033260)Aap Implantate AG2004-12-07
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT (K042883)Howmedica Osteonics Corp.2004-11-23
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES (K042271)Zimmer, Inc.2004-10-13
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ (K040630)Implex Corp.2004-09-30
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS (K041591)Howmedica Osteonics Corp.2004-09-23
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (K041085)Depuy, Inc.2004-07-22
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) (K040281)DePuy Orthopaedics, Inc.2004-07-09
REVISION KNEE SYSTEM (K041106)Smith & Nephew, Inc.2004-07-01
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) (K041466)Biomet Manufacturing Corp2004-07-01
LPS (K033959)Depuy, Inc.2004-07-01
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS (K040964)Howmedica Osteonics Corp.2004-05-28
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS (K032522)Exactech, Inc.2004-05-28
MAXIM ACCEL (VANGUARD) PS+ BEARINGS (K041046)Biomet, Inc.2004-05-21
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE (K040267)Howmedica Osteonics Corp.2004-05-05
VANGUARD PATELLA COMPONENTS (K040770)Biomet Manufacturing, Inc.2004-04-22
DEPUY SIGMA XLK TIBIAL INSERTS (K040166)DePuy Orthopaedics, Inc.2004-02-23
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI (K033883)Exactech, Inc.2004-02-13
DEPUY SIGMA TIBIAL INSERTS (K033272)DePuy Orthopaedics, Inc.2004-02-05
ADVANCE DOUBLE HIGH INSERT (K033890)Wrightmedicaltechnologyinc2004-01-15
SCORPIO KNEE SYSTEM - TIBIAL INSERTS (K033342)Howmedica Osteonics Corp.2004-01-15
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS (K031962)Implex Corp.2004-01-08
GEM INSET PATELLAR COMPONENT (K032950)Kinamed, Inc.2003-12-19
SCORPIO LOW PROFILE TIBIAL TRAY (K032829)Howmedica Osteonics Corp.2003-12-10
SCORPIO NRG KNEE SYSTEM (K030978)Howmedica Osteonics Corp.2003-11-20
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT (K031901)Stelkast Company2003-10-10
HLS NOETOS SYSTEM (K032079)Tornier2003-10-02
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (K032151)Depuy, Inc.2003-09-26
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS (K032606)Exactech, Inc.2003-09-23
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (K032479)Howmedica Osteonics Corp.2003-09-04
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM (K031729)Howmedica Osteonics Corp.2003-09-02
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