Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners2Cleared 510(K)
- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems2Cleared 510(K)
- K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component2Cleared 510(K)
- K240418Stryker Orthopaedics Hip Systems Labeling Update2Cleared 510(K)
- K233261Global Modular Replacement System2Cleared 510(K)
- K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee2Cleared 510(K)
- K220216C-Stem AMT LE Prosthesis2Cleared 510(K)
- K213701Exeter® X3® RimFit® Cup2Cleared 510(K)
- K213816MPO Hip Instruments2Cleared 510(K)
- K210842VerSys Cemented Revision/Calcar2Cleared 510(K)
- K203815ELEOS Limb Salvage System with BioGrip2Cleared 510(K)
- K203588ELEOS™ Limb Salvage System2Cleared 510(K)
- K203090ELEOS Limb Salvage System featuring BIOGRIP2Cleared 510(K)
- K201519PROFEMUR® GLADIATOR® Cemented Classic Stem2Cleared 510(K)
- K193429Exeter V40 Femoral Stem, Exeter X3 RimFit Cup2Cleared 510(K)
- K191449ZCA All-Poly Acetabular Cups2Cleared 510(K)
- K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling I2Cleared 510(K)
- K191735CPT Hip System2Cleared 510(K)
- K191056Conformity stem, cemented2Cleared 510(K)
- K191414EXETER Centralizer, EXETER 2.5mm Plug2Cleared 510(K)
- K181340Cemented TSI Hip Stem2Cleared 510(K)
- K180973Libertas Hip Replacement System2Cleared 510(K)
- K162125MALUC™ Total Hip Arthroplasty System2Cleared 510(K)
- K160923REDAPT Anteverted Cemented Liner2Cleared 510(K)
- K153057FitRite™ Total Hip Arthroplasty System2Cleared 510(K)
- K153725Corin TaperFit Hip Stem2Cleared 510(K)
- K153216Alpine Cemented Hip System2Cleared 510(K)
- K152621OSS/Arcos IM Total Femur Rod2Cleared 510(K)
- K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial2Cleared 510(K)
- K142761Corin TaperFit Hip Stem2Cleared 510(K)
- K141331BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)2Cleared 510(K)
- K142295Sirius Femoral Stem, Size 30A2Cleared 510(K)
- K141370RENOVIS CEMENTED HIP SYSTEM2Cleared 510(K)
- K130610SIRIUS FEMORAL STEM2Cleared 510(K)
- K123598SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION2Cleared 510(K)
- K123501OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS2Cleared 510(K)
- K121056METS MODULAR PROXIMAL FEMUR2Cleared 510(K)
- K121055METS MODULAR TOTAL FEMUR2Cleared 510(K)
- K111863SIGNATURE PLANNER,SIGNATURE GUIDES2Cleared 510(K)
- K120578ACCOLADE II HIP STEM2Cleared 510(K)
- K111848EXETER X3 RIMFIT ACETABULAR CUP2Cleared 510(K)
- K110290EXETER HIP STEM2Cleared 510(K)
- K093646DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS2Cleared 510(K)
- K090998DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS2Cleared 510(K)
- K090208BIOPRO FEMORAL HEADS2Cleared 510(K)
- K082792MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS2Cleared 510(K)
- K082239DEPUY C-STEM AMT2Cleared 510(K)
- K080539ACCIN UNIPOLAR HEAD SYSTEM2Cleared 510(K)
- K080885MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION2Cleared 510(K)
- K072857TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT2Cleared 510(K)
- K070399100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES2Cleared 510(K)
- K070364100KGY E-POLY MAXROM ACETABULAR LINERS2Cleared 510(K)
- K063278PORTLAND COBALT CHROME FEMORAL HEAD2Cleared 510(K)
- K061344EXCIA TOTAL HIP SYSTEM LATERAL OFFSET2Cleared 510(K)
- K052639GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER2Cleared 510(K)
- K052748SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS2Cleared 510(K)
- K052792ANTHOLOGY HIP STEM2Cleared 510(K)
- K051569RINGLOC BI-POLAR ACETABULAR COMPONENT2Cleared 510(K)
- K050637ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS2Cleared 510(K)
- K051407LEGEND ALL-POLY CUP2Cleared 510(K)
- K051516TRABECULAR METAL REVISION SHELL LINERS2Cleared 510(K)
- K050441TAPER 2 POROUS FEMORAL STEM2Cleared 510(K)
- K051363RESTORATION MODULAR SYSTEM2Cleared 510(K)
- K051335ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS2Cleared 510(K)
- K050105NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS2Cleared 510(K)
- K050138MODIFICATION TO: RESTORATION MODULAR SYSTEM2Cleared 510(K)
- K042959DEPUY C-STEM AMT HIP PROSTHESIS2Cleared 510(K)
- K033871IM TOTAL FEMUR2Cleared 510(K)
- K032730FIXION HIP SYSTEM2Cleared 510(K)
- K034028ATH FEMORAL STEM2Cleared 510(K)
- K031474SC TOTAL HIP SYSTEM2Cleared 510(K)
- K030867ESKA MODULAR HIP SYSTEM CEMENTED2Cleared 510(K)
- K03173036MM ORTHINOX V40 FEMORAL HEAD COMPONENTS2Cleared 510(K)
- K032396RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS2Cleared 510(K)
- K031744OMNIFIT HFX HIP STEM SERIES2Cleared 510(K)
- K030766OXINIUM FEMORAL HEADS2Cleared 510(K)
- K031734GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K031165PLUS ORTHOPEDICS CEMENTED HIP STEM2Cleared 510(K)
- K030153ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-322Cleared 510(K)
- K030265CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-002Cleared 510(K)
- K024340SMITH & NEPHEW FEMORAL HEADS2Cleared 510(K)
- K022799TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE2Cleared 510(K)
- K023646EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM2Cleared 510(K)
- K023453DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS2Cleared 510(K)
- K023085RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM2Cleared 510(K)
- K022958TOTAL HIP FEMORAL HEADS AND LINERS2Cleared 510(K)
- K022094PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING2Cleared 510(K)
- K02207736MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)2Cleared 510(K)
- K021822R120 MODULAR TOTAL HIP SYSTEM2Cleared 510(K)
- K021380OSS LES PROXIMAL FEMORAL COMPONENT2Cleared 510(K)
- K02131036MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)2Cleared 510(K)
- K021178SL-PLUS LATERALIZED STEM2Cleared 510(K)
- K020989SUPER EON PLUS FEMORAL STEMS2Cleared 510(K)
- K020970MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)2Cleared 510(K)
- K020291EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER2Cleared 510(K)
- K020076PATRIOT PROTRUSIO CAGE2Cleared 510(K)
- K011887AVALON CUP SYSTEM2Cleared 510(K)
- K013352SUMMIT CEMENTED HIP PROSTHESIS2Cleared 510(K)
- K013350MODIFICATION TO DEPUY C-STEM SYSTEM2Cleared 510(K)
- K012961SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM2Cleared 510(K)
- K011774R120 MODULAR TOTAL HIP SYSTEM2Cleared 510(K)
- K012493ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 02Cleared 510(K)
- K011715MACROPORE IB RESORBABLE PLUG2Cleared 510(K)
- K012019COLOR BUFFED (CB) DDH FEMORAL STEM2Cleared 510(K)
- K012026TRIDENT ALL POLY CUP2Cleared 510(K)
- K011455BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER2Cleared 510(K)
- K011623EXETER HIP SYSTEM WITH V40 TAPER2Cleared 510(K)
- K011367EXCEL FRACTURE CEMENTED HIP STEM2Cleared 510(K)
- K011218ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 12Cleared 510(K)
- K010529TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA2Cleared 510(K)
- K010757LFIT V40 FEMORAL HEAD COMPONENTS2Cleared 510(K)
- K010310MODIFICATION TO TRIDENT ALL POLY CUP2Cleared 510(K)
- K003975BAUMER CEMENTED HIP PROSTHESIS2Cleared 510(K)
- K003976BAUMER MULLER HIP PROSTHESIS2Cleared 510(K)
- K003666TAPER-FIT TOTAL HIP SYSTEM2Cleared 510(K)
- K001956TRIDENT ALL POLY CUP2Cleared 510(K)
- K003421DEPUY C-STEM SYSTEM2Cleared 510(K)
- K002757ONCOLOGY SALVAGE SYSTEM2Cleared 510(K)
- K002324MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA2Cleared 510(K)
- K001759HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ2Cleared 510(K)
- K001571BAUMER FEMORAL HEAD2Cleared 510(K)
- K002106NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER2Cleared 510(K)
- K001932TORNIER CEMENT RESTRICTOR2Cleared 510(K)
- K001376TI-MAX PROTRUSIO CAGE2Cleared 510(K)
- K001078SULZER ORTHOPEDICS MS-30 FEMORAL STEM2Cleared 510(K)
- K001733ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES2Cleared 510(K)
- K000817OMEGA II MODULAR TOTAL HIP SYSTEM2Cleared 510(K)
- K001335ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED2Cleared 510(K)
- K990330CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ2Cleared 510(K)
- K000254PAR 5 ACETABULAR COMPONENT2Cleared 510(K)
- K994007MALLORY/HEAD SMOOTH FEMORAL COMPONENT2Cleared 510(K)
- K993713RIM-FIX, ACETABULAR CUP2Cleared 510(K)
- K992409THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ2Cleared 510(K)
- K992153PE-PLUS ACETABULAR CUP2Cleared 510(K)
- K992903COLOR BUFFED CEMENTED FEMORAL2Cleared 510(K)
- K992490B2C HIP SYSTEM2Cleared 510(K)
- K991869COBREX HIP STEM, MODEL 01-128-XXXXX2Cleared 510(K)
- K99162226 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER2Cleared 510(K)
- K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM2Cleared 510(K)
- K991987COLOR BUFFED ANSWER CEMENTED FEMORAL2Cleared 510(K)
- K991538OPERA CUPFLANGED ACETABULAR COMPONENTS2Cleared 510(K)
- K9912278MM FORGED CEMENTED STEM2Cleared 510(K)
- K990821PROVIDENCE CUP SYSTEM2Cleared 510(K)
- K984227OMEGA II MODULAR TOTAL HIP SYSTEM2Cleared 510(K)
- K990369SYNERGY CEMENTED HIP STEM2Cleared 510(K)
- K990032MODULAR PROTUSIO CUP2Cleared 510(K)
- K984154APF POROUS COATED LINE EXTENSION2Cleared 510(K)
- K980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION2Cleared 510(K)
- K980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION2Cleared 510(K)
- K983226OSTEONICS X CEMENTED HIP STEM SERIES2Cleared 510(K)
- K983128IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY2Cleared 510(K)
- K983710150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH2Cleared 510(K)
- K983136DEPUY LUSTER STEM2Cleared 510(K)
- K982963POLYMER THREADED ANCHOR / SUTURE COMBINATION2Cleared 510(K)
- K982918DEPUY C-STEM SYSTEM2Cleared 510(K)
- K982670CONTEMPORARY ACETABULAR COMPONENT2Cleared 510(K)
- K982598OTI FEMORAL LOCK TOTAL HIP SYSTEM2Cleared 510(K)
- K974685OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS2Cleared 510(K)
- K981855PRINCE MEDICAL CEMENT PLUG2Cleared 510(K)
- K980813RELIANCE LONG STEM FEMORAL COMPONENTS2Cleared 510(K)
- K980843EXETER INTRAMEDULLARY BONE PLUG2Cleared 510(K)
- K980794DUAL LOCK HIP STEM2Cleared 510(K)
- K980513ARTICUL/EZE FEMORAL HEADS2Cleared 510(K)
- K980486IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM2Cleared 510(K)
- K980286ULTIMA ACETABULAR ROOF REINFORCEMENT RING2Cleared 510(K)
- K974558SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM2Cleared 510(K)
- K972791ENCORE LINEAR HIP2Cleared 510(K)
- K973809FOUNDATION FRACTURE STEM2Cleared 510(K)
- K974054DISTAL CENTRALIZER, EXETER II HIP SYSTEM2Cleared 510(K)
- K973453TORNIER CEMENT RESTRICTOR2Cleared 510(K)
- K971681SMC FEMORAL HIP COMPONENT2Cleared 510(K)
- K973296EXTEND HIP STEM2Cleared 510(K)
- K972995THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM2Cleared 510(K)
- K972961STELKAST BIPOLAR SYSTEM2Cleared 510(K)
- K972928KERBOULL CROSS2Cleared 510(K)
- K972792DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS2Cleared 510(K)
- K972641DUAL OFFSET PERFECTA IMC HIP STEM2Cleared 510(K)
- K972460OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)2Cleared 510(K)
- K972435ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM2Cleared 510(K)
- K971890RECOVERY PROTRUSIO CAGE2Cleared 510(K)
- K971705IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED2Cleared 510(K)
- K971581HEMISPHERE CEMENTED CUP2Cleared 510(K)
- K963612DURATION STABILIZED UHMWPE2Cleared 510(K)
- K970697OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K970194PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT2Cleared 510(K)
- K965019THE C-FIT FEMORAL HIP SYSTEM2Cleared 510(K)
- K964003METAGEN ALL POLY ACETABULAR CUP SYSTEM2Cleared 510(K)
- K970351GLOBAL TAPER SPECTRON HIP STEMS2Cleared 510(K)
- K964795CEMENTED CALCAR REPLACEMENT FEMORAL STEM2Cleared 510(K)
- K964655UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE2Cleared 510(K)
- K963671OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP2Cleared 510(K)
- K962468HEDROCEL ACETABULAR RESTRICTOR2Cleared 510(K)
- K964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA2Cleared 510(K)
- K963109HERITAGE HIP SYSTEM2Cleared 510(K)
- K964218PERFECTA PLASMA SPRAY HIP STEM2Cleared 510(K)
- K964262EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD2Cleared 510(K)
- K963486REVISION HIP SYSTEM2Cleared 510(K)
- K963313EXACTECH ALL POLY ACETABULAR CUP2Cleared 510(K)
- K963206S-ROM HIP SYSTEM - LOCKING PLUG2Cleared 510(K)
- K955137IM C-MENT ACETABULAR CAP2Cleared 510(K)
- K960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX2Cleared 510(K)
- K961304AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM2Cleared 510(K)
- K962560VITALITY HIP STEM2Cleared 510(K)
- K960984SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS2Cleared 510(K)
- K960647OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS2Cleared 510(K)
- K962267PERFECTA PS REVISION STEM2Cleared 510(K)
- K962086CPS, CEMENTED CUP SYSTEM2Cleared 510(K)
- K961899CPS, CEMENTED HIP SYSTEM2Cleared 510(K)
- K960278COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT2Cleared 510(K)
- K960658COLLARLESS POLISHED TAPER HIP PROSTHESIS2Cleared 510(K)
- K961799NATURAL HIP SYSTEM - DRG HIP STEM2Cleared 510(K)
- K961619DEPUY ENDURANCE CALCAR HIP PROSTHESIS2Cleared 510(K)
- K960258NATURAL HIP SYSTEM2Cleared 510(K)
- K961890FOUNDATION 9MM FORGED CEMENTED STEM2Cleared 510(K)
- K960025PROTEK LOW PROFILE ACETABULAR CUP2Cleared 510(K)
- K960678BURCH/SCHNEIDER REINFORCEMENT CAGE2Cleared 510(K)
- K960626MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)2Cleared 510(K)
- K954598OSTEONICS OFFSET HIP STEMS2Cleared 510(K)
- K960302CONSENSUS ACETABULAR SHELL, ALL UHMWPE2Cleared 510(K)
- K960340CONSENSUS APEX DOME HOLE PLUG2Cleared 510(K)
- K960339CONSENSUS 22MM COCRMO FEMORAL HEAD2Cleared 510(K)
- K960156CONSENSUS 32MM COCRMO FEMORAL HEAD2Cleared 510(K)
- K960151CONSENSUS 26MM COCRMO FEMORAL HEAD2Cleared 510(K)
- K955620PRIME CEMENTED CALCAR FEMORAL STEMS2Cleared 510(K)
- K955473GAMMA SYSTEM2Cleared 510(K)
- K955296LINK MP RECONSTRUCTION HIP2Cleared 510(K)
- K953202P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT2Cleared 510(K)
- K953200ULTIMA SIZE 0 CEMENTED FEMORAL STEM2Cleared 510(K)
- K952859ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT2Cleared 510(K)
- K955354ALTERNATIVE STERILIZATION PROCESS2Cleared 510(K)
- K954744ZCH ALPHA SYSTEM2Cleared 510(K)
- K952970HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM2Cleared 510(K)
- K952731TOWNLEY ALL POLY ACETABULAR CUP2Cleared 510(K)
- K945774BETA FEMORAL HIP STEM2Cleared 510(K)
- K935585APR ACETABULAR INSERTS IOI BIPOLAR2Cleared 510(K)
- K954219REALITY LONG STEM HIP SYSTEM2Cleared 510(K)
- K951139ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)2Cleared 510(K)
- K954262NEXUS II FEMORAL COMPONENT2Cleared 510(K)
- K953578PROTEK ACETABULAR ROOF REINFORCEMENT RING2Cleared 510(K)
- K953033PRIME CEMENTED SMALL FEMORAL STEM2Cleared 510(K)
- K953025SLT 28MM XXL FEMORAL HEAD2Cleared 510(K)
- K952629NEXFLEX TOTAL HIP SYSTEM2Cleared 510(K)
- K934857HSS FEMORAL COMPONENTS2Cleared 510(K)
- K952191FORGED CEMENTED STEM2Cleared 510(K)
- K935263FOUNDATION POROUS STEM2Cleared 510(K)
- K952461ENDO PROSTHESIS FEMORAL HEAD2Cleared 510(K)
- K951726S-ROM ZTP UHMWPE ACETABULAR CUP2Cleared 510(K)
- K950418ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)2Cleared 510(K)
- K951084S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K945574OSTEONICS(R) CCR HIP STEM SERIES2Cleared 510(K)
- K950312ALPHA SYSTEM2Cleared 510(K)
- K943696ALL POLYETHYLENE CEMENTED ACETABULAR CUP2Cleared 510(K)
- K950761INDEX ACETABULAT COMPONENT2Cleared 510(K)
- K945115MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS2Cleared 510(K)
- K944792ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)2Cleared 510(K)
- K940328PRIME CEMENTED HIP SYSTEM2Cleared 510(K)
- K946371PROVIDENT HP SYSTEM2Cleared 510(K)
- K935449FOUNDATION NON-POROUS STEM2Cleared 510(K)
- K940307HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT2Cleared 510(K)
- K942537PARAMOUNT CEMENTED HIP STEM PROTHESIS2Cleared 510(K)
- K943549RESTORATION ACETABULAR CUP2Cleared 510(K)
- K930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM2Cleared 510(K)
- K942370DEPUY CEMENTED HIP PROSTHESIS2Cleared 510(K)
- K936127HOWMEDICA PREMIUM FEMORAL COMPONENT2Cleared 510(K)
- K936126HOWMEDICS DRG FEMORAL COMPONENT2Cleared 510(K)
- K943302AML TRI-LOCK REPLACEMENT LINER SYSTEM2Cleared 510(K)
- K942966AML TRILOCK REPLACEMENT LINER SYSTEM2Cleared 510(K)
- K941617APR ACETABULAR INSERT2Cleared 510(K)
- K942406OPTION SHELL2Cleared 510(K)
- K942611FOUNDATION ALL POLY CUP2Cleared 510(K)
- K941486INTEGRITY TOTAL HIP SYSTEM, NON-POROUS2Cleared 510(K)
- K930275PRECISION OSTEOLOCK ACETABULAR COMPONENT2Cleared 510(K)
- K935951KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM2Cleared 510(K)
- K935206KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION2Cleared 510(K)
- K936214CS-PLUS STEM2Cleared 510(K)
- K936132EXETER ALL PLASTIC ACETABULAR COMPONENT2Cleared 510(K)
- K932481SL-PLUS AND SLR-PLUS2Cleared 510(K)
- K933281S.O.S. PROXIMAL FEMUR2Cleared 510(K)
- K936043FOUNDATION POROUS ACETABULAR COMPONENT2Cleared 510(K)
- K934169FOUNDATION ALL POLY CUP2Cleared 510(K)
- K932574RMHS POROUS DISTAL SLEEVE2Cleared 510(K)
- K933561OSTEONICS OMNIFIT FORGED HIP STEM SERIES2Cleared 510(K)
- K935012BIOMETRIC TOTAL HIP SYSTEM2Cleared 510(K)
- K930187OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS2Cleared 510(K)
- K933875PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE2Cleared 510(K)
- K903630PRECISION OSTEOFLEX FEMORAL COMPONENT2Cleared 510(K)
- K930460HOWMEDICA REVISION HIP SYSTEM2Cleared 510(K)
- K930223HOWMEDICA ACETABULAR SHELL2Cleared 510(K)
- K926229APC FEMORAL COMPONENT2Cleared 510(K)
- K923243PERFECTA TOTAL HIP SYSTEM2Cleared 510(K)
- K930812APR FEMORAL HIP COMPONENT2Cleared 510(K)
- K925866CENATOR TOTAL HIP SYSTEM2Cleared 510(K)
- K930108RMHS POROUS DISTAL SLEEVE2Cleared 510(K)
- K925201EXACTECH FEMORAL STEM2Cleared 510(K)
- K926323H-110 ACETABULAR CUP SYSTEM2Cleared 510(K)
- K905262BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH2Cleared 510(K)
- K925348IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM2Cleared 510(K)
- K915594STABILITY HIP FEMORAL COMPONENT2Cleared 510(K)
- K923275RMHS MONOLITHIC FEMORAL COMPONENT2Cleared 510(K)
- K922847PERFECTA TOTAL HIP SYSTEM2Cleared 510(K)
- K911058TECHMEDICA CAD/CAM CUSTOM HIP2Cleared 510(K)
- K924323THE UNIVERSAL BONE CEMENT RESISTOR2Cleared 510(K)
- K922862CHARNLEY TYPE HIP PROTHESIS2Cleared 510(K)
- K922860AUSTIN-MOORE TYPE HIP PROSTHESIS2Cleared 510(K)
- K922863EUROSTEM HIP PROTHESIS SYSTEM2Cleared 510(K)
- K922864MUELLER TYPE FEMORAL STEM2Cleared 510(K)
- K922866OTI BONE PLUG2Cleared 510(K)
- K922871UNIFIT FEMORAL STEM2Cleared 510(K)
- K925895ETEX HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K922733PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP2Cleared 510(K)
- K922645LSF ANATOMIC CEMENTED HIP2Cleared 510(K)
- K914078DEPUY HIP PROSTHESIS2Cleared 510(K)
- K924115ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS2Cleared 510(K)
- K920739S-ROM TOTAL HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K923898C-FIT CEMENTED HIP STEM2Cleared 510(K)
- K915500LESTER PRESS FIT HIP PROSTHESIS2Cleared 510(K)
- K922421KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP2Cleared 510(K)
- K922503HOWMEDICA(R) HNR SYSTEM2Cleared 510(K)
- K914675MODULAR FEMORAL HEAD WITH OFFSET TRUNION2Cleared 510(K)
- K922008CDH HIP SYSTEM2Cleared 510(K)
- K914878ZIRCONIUM ALLOY FRMORAL HEAD2Cleared 510(K)
- K920430MODULAR ACETABULAR CUP SYSTEM2Cleared 510(K)
- K920639RX 90 ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K920640FULL HEMISPHERE RING-LOC LINER2Cleared 510(K)
- K921383PRECISION STRATA TOTAL HIP STEM2Cleared 510(K)
- K920286DEPUY TOTAL HIP BALLS - ION IMPLANTATION2Cleared 510(K)
- K920250OSTEONICS MICROSURFACED CDH HIP STEM2Cleared 510(K)
- K920161BIOMET NTS FEMORAL COMPONENTS2Cleared 510(K)
- K920021LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP2Cleared 510(K)
- K920317S-ROM LF FEMORAL HEAD2Cleared 510(K)
- K920003DRG CEMETED STEM2Cleared 510(K)
- K915795PERFECTA PDA TOTAL HIP SYSTEM2Cleared 510(K)
- K915216SOLUTION SYSTEM CUP2Cleared 510(K)
- K911802PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP2Cleared 510(K)
- K914406PT II DISTAL CEMENT SPACER2Cleared 510(K)
- K913231S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD2Cleared 510(K)
- K912712BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS2Cleared 510(K)
- K913634APR II HIP SYSTEM2Cleared 510(K)
- K913874INFINITY(TM) MICROTAPER HIP SYSTEM2Cleared 510(K)
- K913812OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES2Cleared 510(K)
- K913649MODULAR CALCAR REPLACEMENT2Cleared 510(K)
- K913616LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP2Cleared 510(K)
- K913246HYBRID FIT TOTAL HIP SYSTEM2Cleared 510(K)
- K913208APR II NON-POROUS HIP STEM2Cleared 510(K)
- K913060NATURAL POROUS HIP SYSTEM2Cleared 510(K)
- K912593MODULAR HIP SYSTEM2Cleared 510(K)
- K912916APR COLLAR SPACER2Cleared 510(K)
- K912426UHMWP ACETABULAR COMPONENT2Cleared 510(K)
- K911890OSTEONICS(R) PRT HIP STEM SERIES2Cleared 510(K)
- K904737GROSS HIP FEMORAL COMPONENT2Cleared 510(K)
- K911718M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)2Cleared 510(K)
- K911685RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP2Cleared 510(K)
- K910093FUTURA FEMORAL HIP STEM2Cleared 510(K)
- K911684BIOMET COBALT-CHROME FEMORAL COMPONENTS2Cleared 510(K)
- K911052NEXUS(TM) FEMORAL HIP STEM2Cleared 510(K)
- K905298TITAN TOTAL HIP DEVICE2Cleared 510(K)
- K910836LIMA COLLARED CL STEM2Cleared 510(K)
- K910352BIOPRO METAL BACKED CEMENTED ACETABULAR CUP2Cleared 510(K)
- K910869HOWMEDICA(R) CEMETED FEMORAL COMPONENT2Cleared 510(K)
- K905258S-ROM OBLONG ACETABULAR CUP2Cleared 510(K)
- K910662PS OMNIFIT NORMALIZED HIP STEM SERIES2Cleared 510(K)
- K910922OSTEONICS CDH HIP STEM2Cleared 510(K)
- K910988OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES2Cleared 510(K)
- K905408NEXUS ACETABULAR CUP2Cleared 510(K)
- K905275OSTEONICS(R) MPSS HIP STEM SERIES2Cleared 510(K)
- K905406OSTEONICS HIP REVISION WEDGES2Cleared 510(K)
- K905158OSTEONICS(R) 6011 HIP STEM SERIES2Cleared 510(K)
- K904207BIOPRO TRINITY ACETABULAR CUP2Cleared 510(K)
- K903938C FIT CUP2Cleared 510(K)
- K896851PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC2Cleared 510(K)
- K904919PROXIMAL FEMUR REPLACEMENT STEM2Cleared 510(K)
- K904844PRECISION HIP STEM WITH ADDITIONAL STEM SIZES2Cleared 510(K)
- K903957VSP HIP STEM2Cleared 510(K)
- K903635PERFECTA TOTAL HIP SYSTEM2Cleared 510(K)
- K903636OSTEONICS DRM ACETABULAR COMPONENT2Cleared 510(K)
- K903116RM ISOELASTIC BEVELLED ACETABULAR CUP2Cleared 510(K)
- K903362OSTEOLOCK(TM) ACETABULAR CUP2Cleared 510(K)
- K904351FOCUS COBALT CHROMIUM TOTAL HIP2Cleared 510(K)
- K903234F-19 TOTAL HIP PROSTHESIS2Cleared 510(K)
- K902961DIMENSION-II TOTAL HIP SYSTEM2Cleared 510(K)
- K900261ACSYS PREFIX ACETABULAR CUP PROSTHESIS2Cleared 510(K)
- K902621SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT2Cleared 510(K)
- K901451F-20 CEMENTED METAL-BACKED ACETABULAR CUP2Cleared 510(K)
- K902436HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE2Cleared 510(K)
- K902396MODIFIED DEPUY ACETABULAR CUP SYSTEM2Cleared 510(K)
- K902395MODIFIED AML + ACETABULAR CUP SYSTEM2Cleared 510(K)
- K902727LSF CEMENTED FEMORAL HIP2Cleared 510(K)
- K902279KM-5 METAL BACKED ACETABULAR CUP2Cleared 510(K)
- K903243MULLER-TYPE FEMORAL COMPONENT2Cleared 510(K)
- K903242ACETABULAR CUP2Cleared 510(K)
- K902137P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT2Cleared 510(K)
- K901480F-20 TOTAL HIP PROSTHESIS2Cleared 510(K)
- K901460LSF(TM) TOTAL HIP SYSTEM2Cleared 510(K)
- K901328DOMED AND FINNED ACETABULAR COMPONENT2Cleared 510(K)
- K901364HGP II TOTAL HIP FEMERAL STEM2Cleared 510(K)
- K901087MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS2Cleared 510(K)
- K900832MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.2Cleared 510(K)
- K901297EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP2Cleared 510(K)
- K900438MC2P ACETABULAR COMPONENT2Cleared 510(K)
- K900257MULLER TYPE ACETABULAR CUP2Cleared 510(K)
- K901240ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED2Cleared 510(K)
- K900836OSTEONICS ECSI HIP STEM SERIES2Cleared 510(K)
- K900891MODIFIED AML + ACETABULAR CUP PROSTHESIS2Cleared 510(K)
- K895036TITANIUM MODULAR MODULAR COLLARLESS HIP2Cleared 510(K)
- K895035TITANIUM MODULAR COLLARED HIP PROSTHESIS2Cleared 510(K)
- K896325QUANTUM HIP STEM2Cleared 510(K)
- K895636DIMENSION REVISION TOTAL HIP SYSTEM2Cleared 510(K)
- K884890LORD L.F.R. TOTAL HIP SYSTEM2Cleared 510(K)
- K893821ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.2Cleared 510(K)
- K890498FREEMAN MODULAR HIP STEM RIDGED VERSION2Cleared 510(K)
- K894298MODIFIED GEMINI ACETABULAR CUP2Cleared 510(K)
- K894149MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL2Cleared 510(K)
- K894148MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL2Cleared 510(K)
- K894249UNIVERSAL CEMENTED CUP2Cleared 510(K)
- K885192APR COLLARED REVISION FEMORAL COMPONENT2Cleared 510(K)
- K891454EXETER II TOTAL HIP SYSTEM2Cleared 510(K)
- K890742INTRAFORM TOTAL HIP SYSTEM2Cleared 510(K)
- K884027PERFECTA II/NON-COATED TOTAL HIP SYSTEM2Cleared 510(K)
- K885338AML BOWED FEMORAL HIP2Cleared 510(K)
- K890649OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.2Cleared 510(K)
- K890054M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.2Cleared 510(K)
- K884888MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS2Cleared 510(K)
- K883618PERFECTA II TOTAL HIP SYSTEM2Cleared 510(K)
- K884432MODIFIED LSF TOTAL HIP SYSTEM2Cleared 510(K)
- K883941PROFORMA HIP SYSTEM2Cleared 510(K)
- K884457MODULAR COLLARED HJD TOTAL HIP SYSTEM2Cleared 510(K)
- K883724GEMINI FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K882869TOWNLEY COX COMB ACETABULAR COMPONENT2Cleared 510(K)
- K883460FOCUS TOTAL HIP SYSTEM2Cleared 510(K)
- K882146BIOPRO PC FEMORAL HIP COMPONENT2Cleared 510(K)
- K882812OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM2Cleared 510(K)
- K880435PROFORMA/PS TOTAL HIP SYSTEM2Cleared 510(K)
- K881769HJD CALCAR REPLACEMENT PROSTHESIS2Cleared 510(K)
- K880269LCS FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K881117RESUBMITTING OF HJD TOTAL HIP SYSTEM2Cleared 510(K)
- K871867ELITE MODULAR HIP SYSTEM2Cleared 510(K)
- K880390INTRAFORM TOTAL HIP SYSTEM2Cleared 510(K)
- K881128TITANIUM FEMORAL HIP2Cleared 510(K)
- K880461PERFECTA TOTAL HIP SYSTEM2Cleared 510(K)
- K880004TOWNLEY COX COMB ACETABULAR CUP2Cleared 510(K)
- K871852COXA ACETABULAR CUP2Cleared 510(K)
- K874619SPECTRON EF ACETABULAR COMPONENT2Cleared 510(K)
- K874599MOORE HIP PROSTHESIS SOLID STEM2Cleared 510(K)
- K874616MOORE HIP PROSTHESIS FENESTRATED STEM2Cleared 510(K)
- K874093SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP2Cleared 510(K)
- K873626FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM2Cleared 510(K)
- K873632HI-NEK TOTAL HIP2Cleared 510(K)
- K873857WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS2Cleared 510(K)
- K874229ANATOMIC TOTAL HIP2Cleared 510(K)
- K873999PREMIER-TOTAL (TM) HIP2Cleared 510(K)
- K873585POROUS COATED ACETABULAR CUP2Cleared 510(K)
- K870922C.L.E. ACETABULAR CUP2Cleared 510(K)
- K872732MCCUTCHEN ACETABULAR CUP PROSTHESIS2Cleared 510(K)
- K864999KENNEDY STEM2Cleared 510(K)
- K872856BIOPRO 32MM BALL2Cleared 510(K)
- K871402MURRAY/WELCH TOTAL HIP SYSTEM2Cleared 510(K)
- K871347WAGNER REVISIONAL FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K871857HPS II CALCAR FEMORAL PROSTHESIS2Cleared 510(K)
- K871462PROSTHETIC - FEMORAL HIP COMPONENT2Cleared 510(K)
- K870235OMNIFIT II HIP PROSTHESES: CEMENT FIXATION2Cleared 510(K)
- K871401KIRSCHNER MODULAR HIP SYSTEM2Cleared 510(K)
- K870128HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)2Cleared 510(K)
- K870699STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP2Cleared 510(K)
- K871299SDI TOTAL HIP SYSTEM2Cleared 510(K)
- K864857OPTI-FIX ACETABULAR COMPONENT2Cleared 510(K)
- K870445THREADED ACETABULAR COMPONENT2Cleared 510(K)
- K870216MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS2Cleared 510(K)
- K861988MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY2Cleared 510(K)
- K863184PROFILE HIP ACETABULUM PROSTHESIS2Cleared 510(K)
- K861979AML II TITANIUM ACETABULUM PROSTHESIS2Cleared 510(K)
- K861433UNIVERSAL ACETABULAR COMPONENT2Cleared 510(K)
- K862234EXACTECH TOTAL HIP SYSTEM2Cleared 510(K)
- K862225INTERNATIONAL TOTAL HIP SYSTEM2Cleared 510(K)
- K861930CM-6 TOTAL HIP SYSTEM2Cleared 510(K)
- K855017LSF* TOTAL HIP SYSTEM2Cleared 510(K)
- K861114MALLORY/HEAD - PF ACETABULAR COMPONENT2Cleared 510(K)
- K860002CONICAL COLLAR HIP PROSTHESIS POROUS COATED2Cleared 510(K)
- K855200MODULAR PRESS FIT (MPF) STEM2Cleared 510(K)
- K860701HPS II SMOOTH STEM2Cleared 510(K)
- K854465LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM2Cleared 510(K)
- K853916P.M. HIP-FEMORAL PROSTHESIS2Cleared 510(K)
- K844050ARTHOPOR-ACETABULAR COMPONENT2Cleared 510(K)
- K853886P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K854046CONICAL COLLAR HIP PROSTHESIS2Cleared 510(K)
- K853768MULLER SELF LOCKING TOTAL HIP2Cleared 510(K)
- K853408COLLAR LESS AML HIP2Cleared 510(K)
- K853169GT HIP PROSTHESIS FEMORAL COMPONENT2Cleared 510(K)
- K852839FREEMAN HIP2Cleared 510(K)
- K853655NEW JERSEY MODULAR FEMORAL HIP2Cleared 510(K)
- K844319KM-2 METAL-BACKED ACETABULAR CUP2Cleared 510(K)
- K852517CLS HIP PROSTHESIS2Cleared 510(K)
- K851422S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP2Cleared 510(K)
- K852585POROUS APF/MODULAR FEMORAL COMPONENT2Cleared 510(K)
- K852546HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY2Cleared 510(K)
- K852153THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP2Cleared 510(K)
- K852705LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS2Cleared 510(K)
- K844787BIOMETRIC TOTAL HIP SYSTEM2Cleared 510(K)
- K844817MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM2Cleared 510(K)
- K844941CFE ACETABULAR CUP2Cleared 510(K)
- K845005BROOKER ACETABULAR CUP2Cleared 510(K)
- K844028LORD SCREW RING ACETABULAR COMPONENT2Cleared 510(K)
- K843190HAP ACETABULAR CUP2Cleared 510(K)
- K843909TITANIUM HIP 10192Cleared 510(K)
- K842360DORR HIP PROSTHESIS FEMORAL COMPONENT2Cleared 510(K)
- K842906BIAS TOTAL HIP2Cleared 510(K)
- K842202NEW JERSEY ACETABULAR COMPONENT &2Cleared 510(K)
- K834035UNIVERSAL SELF-ALIGNING ACETABULAR COM2Cleared 510(K)
- K840643HARRIS-GALANTE POROUS TOTAL HIP SYS2Cleared 510(K)
- K841391WEBER-STUHMER HIP PROSTHESIS STEM2Cleared 510(K)
- K840150TOTAL HIP FEMORAL COMPONENT2Cleared 510(K)
- K840357SSA HIP PROSTHESIS2Cleared 510(K)
- K833881ACETABULAR SCREW RING2Cleared 510(K)
- K833912GALANTE FIBER METAL TOTAL HIP2Cleared 510(K)
- K832958FREEMAN ACETABULAR CUP2Cleared 510(K)
- K832211DOSIMETRIC RELEASE OF GAMMA RADIATION2Cleared 510(K)
- K830361MMS ACETABULAR CUPS2Cleared 510(K)
- K831884SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL2Cleared 510(K)
- K831373P.C.A. HIP SYSTEM2Cleared 510(K)
- K831986METAL-BACKED ACE TABULAR CUP2Cleared 510(K)
- K831314INTERFERENCE MEDULLARY FIT -IMF-HIP2Cleared 510(K)
- K830948WEBER/STIIHMER FEMORAL HEAD PROSTHESIS2Cleared 510(K)
- K830314MILWAUKEE AUSTIN MOORE TOTAL HIP2Cleared 510(K)
- K830313CFE TOTAL HIP FEMORAL COMPONENT2Cleared 510(K)
- K830209LUS ACETABULAR COMPONENT2Cleared 510(K)
- K830857HARRIS A.R. C. ACETABULAR CUP2Cleared 510(K)
- K830750CEMENTED 101 32 FEMORAL COMPONENT2Cleared 510(K)
- K830004POROCOAT DUAL-LOCK TOTAL HIP SYSTEM2Cleared 510(K)
- K830356TITANIUM M.E. MULLER TYPE TOTAL HIP2Cleared 510(K)
- K823723SPECTRON PROXIMAL FEMORAL PROSTHESIS2Cleared 510(K)
- K823724SPECTRON NECK REPLACEMENT PROSTHESIS2Cleared 510(K)
- K823727SPECTRON PRIMARY STEM FEMORAL PROSTHES2Cleared 510(K)
- K823722SPECTRON LONG, STRAIGHT FEMORAL PROSTHES2Cleared 510(K)
- K823728SPECTRON POLYETHYLENE ACCTUBULAR COMPON2Cleared 510(K)
- K823725SPECTRON PROTRUSIO CUP2Cleared 510(K)
- K823729SPECTRON METAL BACK ACETABULAR COMPONENT2Cleared 510(K)
- K823419HC 1M METALBACKED ACETABULAR CUP2Cleared 510(K)
- K822979CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES2Cleared 510(K)
- K821893ZIMMER METAL BACKED ACETABULAR CUP2Cleared 510(K)
- K821713POROCOAT LOW PROFILE METAL BACKED CUP2Cleared 510(K)
- K821714POROCOAT STANDARD METAL BACKED CUP2Cleared 510(K)
- K821369TITANIUM AUFRANC-TURNER ATS HIP SYS2Cleared 510(K)
- K821066CONTOUR II LINK SP TOTAL HIP PROSTHESIS2Cleared 510(K)
- K813600AUFRANC-TURNER TYPE ACETABULAR COMPON2Cleared 510(K)
- K813089CEMENT RING2Cleared 510(K)
- K812801HIP STEM SYSTEM TITANIUM ALLOY2Cleared 510(K)
- K802342PROXIMAL INTERPHALANGEAL JOINT IMPLANT2Cleared 510(K)
- K812182MIAMI, PROTRUSIO RING2Cleared 510(K)
- K811293EFTEKHAR CENTRALIZING PLUG2Cleared 510(K)
- K811151COLLARLESS TOTAL HIP FEMORAL COMP. SYS2Cleared 510(K)
- K803126EXETER TOTAL HIP SYSTEM2Cleared 510(K)
- K810120REINFORCED HIP CUP2Cleared 510(K)
- K803074FERNORAL HIP PROSTHESIS2Cleared 510(K)
- K802627ORTRON 90* HIP PROSTHESIS2Cleared 510(K)
- K802872AUFRANC-TURNER ATS TOTAL HIP SYSTEM2Cleared 510(K)
- K8004873M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM2Cleared 510(K)
- K790488INTERPLANTA SP TOTAL HIP PROSTHESIS2Cleared 510(K)
- K780398CUP, ACETABULAR, LONG POSTERIOR WALL2Cleared 510(K)
- K780317TOTAL HIP SYSTEM, HARRIS HD22Cleared 510(K)
- K780052PROSTHESIS, DOUBLE CUP2Cleared 510(K)
- K770908PROSTHESIS, HIP, TRAPEZOIDAL-282Cleared 510(K)
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PROFEMUR® GLADIATOR® Cemented Classic Stem
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K201519
- 510(k) Type
- Traditional
- Applicant
- Microport Orthopedics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/10/2020
- Days to Decision
- 185 days
- Submission Type
- Summary