Orthopedic

JDI · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Orthopedic · 21 CFR 888.3350 · Class 2

Overview

Product CodeJDI
Device NameProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation21 CFR 888.3350
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class II.

Cleared Devices (562)

RecordDevice NameApplicantDecision DateDecision
K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometJul 31, 2025SESE
K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.Oct 21, 2024SESE
K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsAug 2, 2024SESE
K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker OrthopaedicsApr 12, 2024SESE
K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsDec 8, 2023SESE
K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker OrthopaedicsJan 26, 2023SESE
K220216C-Stem AMT LE ProsthesisDepuy Ireland UCJul 22, 2022SESE
K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker OrthopaedicsFeb 1, 2022SESE
K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.Jan 5, 2022SESE
K210842VerSys Cemented Revision/CalcarZimmer, Inc.Dec 10, 2021SESE
K203815ELEOS Limb Salvage System with BioGripOnkos SurgicalJun 9, 2021SESE
K203588ELEOS™ Limb Salvage SystemOnkos SurgicalFeb 5, 2021SESE
K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos SurgicalDec 11, 2020SESE
K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.Dec 10, 2020SESE
K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.Aug 13, 2020SESE
K191449ZCA All-Poly Acetabular CupsZimmer, Inc.Jul 16, 2020SESE
K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.Jul 9, 2020SESE
K191735CPT Hip SystemZimmer, Inc.Mar 20, 2020SESE
K191056Conformity stem, cementedUnited Orthopedic CorporationJan 3, 2020SESE
K191414EXETER Centralizer, EXETER 2.5mm PlugStryker OrthopaedicsAug 28, 2019SESE
K181340Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.Feb 11, 2019SESE
K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.Sep 28, 2018SESE
K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc.May 10, 2017SESE
K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.Nov 17, 2016SESE
K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.Jun 23, 2016SESE
K153725Corin TaperFit Hip StemCorin U.S.A. LimitedMar 25, 2016SESE
K153216Alpine Cemented Hip SystemOrtho Development CorporationFeb 18, 2016SESE
K152621OSS/Arcos IM Total Femur RodBiomet, Inc.Oct 14, 2015SESE
K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLCJun 25, 2015SESE
K142761Corin TaperFit Hip StemCorin USAApr 3, 2015SESE
K141331BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)Biomet, Inc.Oct 27, 2014SESE
K142295Sirius Femoral Stem, Size 30ABiomet, Inc.Sep 15, 2014SESE
K141370RENOVIS CEMENTED HIP SYSTEMRenovis Surgical Technologies, Inc.Sep 2, 2014SESE
K130610SIRIUS FEMORAL STEMBiomet, Inc.Aug 30, 2013SESE
K123598SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.Jun 28, 2013SESE
K123501OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTSBiomet, Inc.Feb 27, 2013SESE
K121056METS MODULAR PROXIMAL FEMURStanmore Implants Worldwide , Ltd.Sep 20, 2012SESE
K121055METS MODULAR TOTAL FEMURStanmore Implants Worldwide , Ltd.Sep 19, 2012SESE
K111863SIGNATURE PLANNER,SIGNATURE GUIDESMaterialise NVJun 15, 2012SESE
K120578ACCOLADE II HIP STEMHowmedica OsteonicsMar 29, 2012SESE
K111848EXETER X3 RIMFIT ACETABULAR CUPStryker Corp.Oct 5, 2011SESE
K110290EXETER HIP STEMHowmedica Osteonics Corp.Sep 27, 2011SESE
K093646DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPSDePuy Orthopaedics, Inc.Dec 17, 2009SESE
K090998DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPSDePuy Orthopaedics, Inc.Jun 12, 2009SESE
K090208BIOPRO FEMORAL HEADSBiopro, Inc.May 22, 2009SESE
K082792MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMSMedacta International S.A.Dec 29, 2008SESE
K082239DEPUY C-STEM AMTDePuy Orthopaedics, Inc.Aug 29, 2008SESE
K080539ACCIN UNIPOLAR HEAD SYSTEMAccelerated Innovation, LLCJun 2, 2008SESE
K080885MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSIONMedacta International S.A.Apr 28, 2008SESE
K072857TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOTMedacta International S.A.Feb 4, 2008SESE
K070399100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILESBiomet Manufacturing, Inc.May 4, 2007SESE
K070364100KGY E-POLY MAXROM ACETABULAR LINERSBiomet, Inc.May 3, 2007SESE
K063278PORTLAND COBALT CHROME FEMORAL HEADPortland Orthopaedics LimitedJan 12, 2007SESE
K061344EXCIA TOTAL HIP SYSTEM LATERAL OFFSETAesculap, Inc.Aug 2, 2006SESE
K052639GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACERBiomet Manufacturing, Inc.May 3, 2006SESE
K052748SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTSHowmedica Osteonics Corp.Dec 2, 2005SESE
K052792ANTHOLOGY HIP STEMSmith & Nephew, Inc.Oct 7, 2005SESE
K051569RINGLOC BI-POLAR ACETABULAR COMPONENTBiomet, Inc.Sep 29, 2005SESE
K050637ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADSOrtho Development Corp.Sep 23, 2005SESE
K051407LEGEND ALL-POLY CUPOrtho Development Corp.Sep 8, 2005SESE
K051516TRABECULAR METAL REVISION SHELL LINERSZimmer, Inc.Jul 27, 2005SESE
K050441TAPER 2 POROUS FEMORAL STEMBiomet, Inc.Jun 29, 2005SESE
K051363RESTORATION MODULAR SYSTEMHowmedica Osteonics Corp.Jun 23, 2005SESE
K051335ACUMATCH 12/14 PRESS-FIT FEMORAL STEMSExactech, Inc.Jun 21, 2005SESE
K050105NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERSZimmer, Inc.May 17, 2005SESE
K050138MODIFICATION TO: RESTORATION MODULAR SYSTEMHowmedica Osteonics Corp.Mar 21, 2005SESE
K042959DEPUY C-STEM AMT HIP PROSTHESISDePuy Orthopaedics, Inc.Dec 22, 2004SESE
K033871IM TOTAL FEMURBiomet, Inc.Apr 16, 2004SESE
K032730FIXION HIP SYSTEMDisc-O-Tech Medical Technologies, Ltd.Mar 26, 2004SESE
K034028ATH FEMORAL STEMWrightmedicaltechnologyincMar 11, 2004SESE
K031474SC TOTAL HIP SYSTEMOrthopedic Alliance, LLCOct 15, 2003SESE
K030867ESKA MODULAR HIP SYSTEM CEMENTEDEska Implants GmbHSep 22, 2003SESE
K03173036MM ORTHINOX V40 FEMORAL HEAD COMPONENTSHowmedica Osteonics Corp.Aug 29, 2003SESE
K032396RINGLOC 36MM LINE AND MODULAR FEMORAL HEADSBiomet, Inc.Aug 21, 2003SESE
K031744OMNIFIT HFX HIP STEM SERIESHowmedica Osteonics Corp.Aug 8, 2003SESE
K030766OXINIUM FEMORAL HEADSSmith & Nephew, Inc.Jul 25, 2003SESE
K031734GENERATION 4 POLISHED FEMORAL HIP PROSTHESISBiomet, Inc.Jul 1, 2003SESE
K031165PLUS ORTHOPEDICS CEMENTED HIP STEMPlus OrthopedicsJun 6, 2003SESE
K030153ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32Zimmer, Inc.Apr 1, 2003SESE
K030265CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00Zimmer, Inc.Mar 4, 2003SESE
K024340SMITH & NEPHEW FEMORAL HEADSSmith & Nephew, Inc.Feb 26, 2003SESE
K022799TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKEHowmedica Osteonics Corp.Nov 21, 2002SESE
K023646EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEMExactech, Inc.Nov 13, 2002SESE
K023453DEPUY SUMMIT FX CEMENTED HIP PROSTHESISDePuy Orthopaedics, Inc.Nov 13, 2002SESE
K023085RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEMBiomet Orthopedics, Inc.Oct 17, 2002SESE
K022958TOTAL HIP FEMORAL HEADS AND LINERSSmith & Nephew, Inc.Oct 2, 2002SESE
K022094PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATINGBiomet, Inc.Jul 25, 2002SESE
K02207736MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)Howmedica Osteonics Corp.Jul 25, 2002SESE
K021822R120 MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.Jul 23, 2002SESE
K021380OSS LES PROXIMAL FEMORAL COMPONENTBiomet, Inc.May 28, 2002SESE
K02131036MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)Howmedica Osteonics Corp.May 21, 2002SESE
K021178SL-PLUS LATERALIZED STEMPlus OrthopedicsMay 14, 2002SESE
K020989SUPER EON PLUS FEMORAL STEMSHowmedica Osteonics Corp.Apr 26, 2002SESE
K020970MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)Biomet, Inc.Apr 4, 2002SESE
K020291EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZERExactech, Inc.Feb 27, 2002SESE
K020076PATRIOT PROTRUSIO CAGEBiomet Orthopedics, Inc.Jan 30, 2002SESE
K011887AVALON CUP SYSTEMOrthopedic Source, Inc.Dec 27, 2001SESE
K013352SUMMIT CEMENTED HIP PROSTHESISDePuy Orthopaedics, Inc.Dec 17, 2001SESE
K013350MODIFICATION TO DEPUY C-STEM SYSTEMDePuy Orthopaedics, Inc.Nov 7, 2001SESE
K012961SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEMSulzer Orthopedics, Inc.Oct 18, 2001SESE
K011774R120 MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.Sep 5, 2001SESE
K012493ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0Exactech, Inc.Aug 29, 2001SESE
K011715MACROPORE IB RESORBABLE PLUGMacropore Biosurgery, Inc.Aug 27, 2001SESU
K012019COLOR BUFFED (CB) DDH FEMORAL STEMBiomet, Inc.Jul 20, 2001SESE
K012026TRIDENT ALL POLY CUPHowmedica Osteonics Corp.Jul 18, 2001SESE
K011455BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTERBiomet, Inc.Jul 18, 2001SESE
K011623EXETER HIP SYSTEM WITH V40 TAPERHowmedica Osteonics Corp.Jun 15, 2001SESE
K011367EXCEL FRACTURE CEMENTED HIP STEMDePuy Orthopaedics, Inc.Jun 15, 2001SESE
K011218ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1Exactech, Inc.May 16, 2001SESE
K010529TITANIUM CEMENT RESTRICTOR MATERIAL PLDLAMedtronic Sofamor Danek USA, Inc.Apr 27, 2001SESU
K010757LFIT V40 FEMORAL HEAD COMPONENTSHowmedica Osteonics Corp.Apr 11, 2001SESE
K010310MODIFICATION TO TRIDENT ALL POLY CUPHowmedica Osteonics Corp.Mar 20, 2001SESE
K003976BAUMER MULLER HIP PROSTHESISBaumer, S.AMar 19, 2001SESE
K003975BAUMER CEMENTED HIP PROSTHESISBaumer, S.AMar 19, 2001SESE
K003666TAPER-FIT TOTAL HIP SYSTEMCorin USAFeb 8, 2001SESE
K001956TRIDENT ALL POLY CUPHowmedica Osteonics Corp.Dec 11, 2000SESE
K003421DEPUY C-STEM SYSTEMDePuy Orthopaedics, Inc.Dec 1, 2000SESE
K002757ONCOLOGY SALVAGE SYSTEMBiomet, Inc.Nov 24, 2000SESE
K002324MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMASulzermedicaAug 24, 2000SESE
K001759HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZImplex Corp.Aug 24, 2000SESE
K001571BAUMER FEMORAL HEADBaumer, S.AAug 4, 2000SESE
K002106NEW BIO-MOORE ENDO HEAD, TAPER ADAPTERBiomet, Inc.Jul 27, 2000SESE
K001932TORNIER CEMENT RESTRICTORTornierJul 20, 2000SESE
K001376TI-MAX PROTRUSIO CAGEBiomet, Inc.Jul 20, 2000SESE
K001078SULZER ORTHOPEDICS MS-30 FEMORAL STEMSulzer Orthopedics, Inc.Jun 23, 2000SESE
K001733ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIESZimmer, Inc.Jun 20, 2000SESE
K000817OMEGA II MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.Jun 8, 2000SESE
K001335ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTEDExactech, Inc.May 18, 2000SESE
K990330CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZImplex Corp.Mar 1, 2000SESE
K000254PAR 5 ACETABULAR COMPONENTBiomet, Inc.Feb 7, 2000SESE
K994007MALLORY/HEAD SMOOTH FEMORAL COMPONENTBiomet, Inc.Feb 4, 2000SESE
K993713RIM-FIX, ACETABULAR CUPSurgical Implants, Inc.Jan 28, 2000SESE
K992409THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZImplex Corp.Oct 8, 1999SESE
K992153PE-PLUS ACETABULAR CUPPlus OrthopedicsSep 23, 1999SESE
K992903COLOR BUFFED CEMENTED FEMORALBiomet, Inc.Sep 17, 1999SESE
K992490B2C HIP SYSTEMLepine Groupe Spa.Aug 19, 1999SESE
K991869COBREX HIP STEM, MODEL 01-128-XXXXXImplex Corp.Jul 14, 1999SESE
K99162226 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINERStelkast CompanyJul 14, 1999SESE
K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMBiomet, Inc.Jul 1, 1999SESE
K991987COLOR BUFFED ANSWER CEMENTED FEMORALBiomet, Inc.Jun 28, 1999SESE
K991538OPERA CUPFLANGED ACETABULAR COMPONENTSSmith & Nephew, Inc., Orthopaedic Div.Jun 3, 1999SESE
K9912278MM FORGED CEMENTED STEMEncore Orthopedics, Inc.Jun 1, 1999SESE
K990821PROVIDENCE CUP SYSTEMBiopro, Inc.Apr 29, 1999SESE
K984227OMEGA II MODULAR TOTAL HIP SYSTEMOsteoimplant Technology, Inc.Apr 8, 1999SESE
K990369SYNERGY CEMENTED HIP STEMSmith & Nephew, Inc.Mar 12, 1999SESE
K990032MODULAR PROTUSIO CUPBiomet, Inc.Feb 18, 1999SESE
K984154APF POROUS COATED LINE EXTENSIONBiomet, Inc.Feb 11, 1999SESE
K980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONHowmedica Corp.Dec 16, 1998SESE
K980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONHowmedica Corp.Dec 11, 1998SESE
K983226OSTEONICS X CEMENTED HIP STEM SERIESOsteonics Corp.Dec 4, 1998SESE
K983128IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYYImplex Corp.Dec 3, 1998SESE
K983710150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISHBiomet, Inc.Dec 2, 1998SESE
K983136DEPUY LUSTER STEMDePuy Orthopaedics, Inc.Nov 25, 1998SESE
K982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONOrthopaedic Biosystems, Ltd.Nov 20, 1998SESE
K982918DEPUY C-STEM SYSTEMDePuy Orthopaedics, Inc.Oct 5, 1998SESE
K982670CONTEMPORARY ACETABULAR COMPONENTHowmedica Corp.Oct 2, 1998SESE
K982598OTI FEMORAL LOCK TOTAL HIP SYSTEMOsteoimplant Technology, Inc.Oct 2, 1998SESE
K974685OSTEONICS POLYETHYLENE ACETABULAR COMPONENTSOsteonics Corp.Sep 22, 1998SESE
K981855PRINCE MEDICAL CEMENT PLUGPrince Medical, Inc.Aug 10, 1998SESE
K980813RELIANCE LONG STEM FEMORAL COMPONENTSHowmedica, Inc.Jun 26, 1998SESE
K980843EXETER INTRAMEDULLARY BONE PLUGHowmedica, Inc.Jun 2, 1998SESE
K980794DUAL LOCK HIP STEMDepuy, Inc.May 20, 1998SESE
K980513ARTICUL/EZE FEMORAL HEADSDePuy Orthopaedics, Inc.Apr 14, 1998SESE
K980486IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEMImplex Corp.Apr 14, 1998SESE
K980286ULTIMA ACETABULAR ROOF REINFORCEMENT RINGJohnson & Johnson Professionals, Inc.Apr 3, 1998SESE
K974558SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEMBiomet, Inc.Mar 4, 1998SESE
K972791ENCORE LINEAR HIPEncore Orthopedics, Inc.Jan 12, 1998SN
K973809FOUNDATION FRACTURE STEMEncore Orthopedics, Inc.Jan 2, 1998SESE
K974054DISTAL CENTRALIZER, EXETER II HIP SYSTEMHowmedica, Inc.Dec 23, 1997SESE
K973453TORNIER CEMENT RESTRICTORTornierDec 9, 1997SESE
K971681SMC FEMORAL HIP COMPONENTSignal Medical Corp.Dec 4, 1997SESE
K973296EXTEND HIP STEMWrightmedicaltechnologyincNov 24, 1997SESE
K972995THE C-FIT & DC-FIT ACETABULAR CUP SYSTEMCorin USANov 10, 1997SESE
K972961STELKAST BIPOLAR SYSTEMStelkast CompanyNov 4, 1997SESE
K972928KERBOULL CROSSHowmedica, Inc.Nov 3, 1997SN
K972792DURATION STABILIZED UHMWPE ACETABULAR COMPONENTSHowmedica Corp.Oct 16, 1997SESE
K972641DUAL OFFSET PERFECTA IMC HIP STEMWrightmedicaltechnologyincOct 9, 1997SESE
K972460OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)Osteonics Corp.Sep 25, 1997SESE
K972435ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEMJohnson & Johnson Professionals, Inc.Sep 11, 1997SESE
K971890RECOVERY PROTRUSIO CAGEBiomet, Inc.Aug 7, 1997SESE
K971705IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTEDImplex Corp.Aug 6, 1997SESE
K971581HEMISPHERE CEMENTED CUPOrtho Development Corp.Jul 18, 1997SESE
K963612DURATION STABILIZED UHMWPEHowmedica Corp.Jun 11, 1997SESE
K970697OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEMOsteonics Corp.Apr 24, 1997SESE
K970194PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENTStelkast CompanyApr 14, 1997SESE
K965019THE C-FIT FEMORAL HIP SYSTEMCorin USAMar 25, 1997SESE
K964003METAGEN ALL POLY ACETABULAR CUP SYSTEMMetagen, LLCMar 21, 1997SESE
K970351GLOBAL TAPER SPECTRON HIP STEMSSmith & Nephew, Inc., Orthopaedic Div.Feb 28, 1997SESE
K964795CEMENTED CALCAR REPLACEMENT FEMORAL STEMJohnson & Johnson Professionals, Inc.Feb 19, 1997SESE
K964655UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGEHowmedica Corp.Feb 6, 1997SESE
K963671OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUPOsteonics Corp.Feb 3, 1997SESE
K962468HEDROCEL ACETABULAR RESTRICTORImplex Corp.Feb 3, 1997SESE
K964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMAIntermedics OrthopedicsJan 16, 1997SESE
K963109HERITAGE HIP SYSTEMZimmer, Inc.Jan 9, 1997SESE
K964218PERFECTA PLASMA SPRAY HIP STEMWrightmedicaltechnologyincJan 8, 1997SESE
K964262EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEADExactech, Inc.Dec 27, 1996SESE
K963486REVISION HIP SYSTEMSmith & Nephew Richards, Inc.Nov 27, 1996SESE
K963313EXACTECH ALL POLY ACETABULAR CUPExactech, Inc.Nov 14, 1996SESE
K963206S-ROM HIP SYSTEM - LOCKING PLUGJohnson & Johnson Professionals, Inc.Oct 17, 1996SESE
K955137IM C-MENT ACETABULAR CAPImplant Ideas, LLCOct 10, 1996SESE

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