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
- 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
- K250450Coated hip implants2Cleared 510(K)
- K243021Longboard Revision Hip Stem2Cleared 510(K)
- K251906Z1 Hip System2Cleared 510(K)
- K251292RECLAIM Monobloc Revision Femoral Stem2Cleared 510(K)
- K243927MobileLink Acetabular Cup System - inhouse coatings2Cleared 510(K)
- K250444NEXUS® Hip Stem2Cleared 510(K)
- K243043Origin™ Cemented Hip Stem2Cleared 510(K)
- K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)2Cleared 510(K)
- K250571CATALYSTEM Femoral Stems2Cleared 510(K)
- K243029Origin™ TT Stem2Cleared 510(K)
- K241767Versacem Acetabular Shell and Double Mobility HC Liners2Cleared 510(K)
- K243809Biolox® Delta Revision heads2Cleared 510(K)
- K241483ceramys™ femoral head system2Cleared 510(K)
- K243466Conformity Stem Extension Line, #02Cleared 510(K)
- K243444BIOCERAM AZUL® HEAD2Cleared 510(K)
- K240528b-ONE® Total Hip System2Cleared 510(K)
- K240391MUTARS® femoral stem cemented 160 mm and 200 mm2Cleared 510(K)
- K242249Conformity Stem Extension Line2Cleared 510(K)
- K241241Z1 Cemented Hip System2Cleared 510(K)
- K240381CATALYSTEM Femoral Stems2Cleared 510(K)
- K240834EcoFit® short stem cementless cpTi2Cleared 510(K)
- K23402522.2mm BIOLOX® delta Ceramic V40™ Femoral Heads2Cleared 510(K)
- K240452Ceramic Femoral Head2Cleared 510(K)
- K23372428mm/38D MDM X3 Insert for MDM Liner2Cleared 510(K)
- K233476Z1 Hip System2Cleared 510(K)
- K223745Novae® Dual Mobility System, Hype® Hip System2Cleared 510(K)
- K232371Actinia® hip stems2Cleared 510(K)
- K233233EMPHASYS Femoral Stems2Cleared 510(K)
- K231925MINIMA S System2Cleared 510(K)
- K223103BethaLoc® stem cementless HA2Cleared 510(K)
- K231109Xerxes Hip Stem2Cleared 510(K)
- K221323Exactech® Alteon® Short Tapered Wedge2Cleared 510(K)
- K223828BENCOX Delta Option Heads2Cleared 510(K)
- K222296ARTICUL/EZE Ceramic Heads2Cleared 510(K)
- K221149U-Motion II Acetabular System-Extension line2Cleared 510(K)
- K221462DePuy Reclaim Monobloc Revision Femoral Stem2Cleared 510(K)
- K220483Platform® Acetabular System2Cleared 510(K)
- K213770SP-CL Hip Stem and LCU Hip System2Cleared 510(K)
- K210678implaFit® hip stems2Cleared 510(K)
- K211891DM Converter - TiN coated2Cleared 510(K)
- K211567BiMobile Instruments (for BiMobile Dual Mobility System)2Cleared 510(K)
- K212327M-Vizion Monobloc2Cleared 510(K)
- K220405Amis K Long2Cleared 510(K)
- K213675MP Reconstruction System2Cleared 510(K)
- K212069Corin MetaFix™ Hip Stem2Cleared 510(K)
- K213839DePuy Corail AMT Hip Prosthesis2Cleared 510(K)
- K213129Restoration Modular 115mm Conical Distal Stem2Cleared 510(K)
- K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length2Cleared 510(K)
- K210263Mpres Neck Preserving Stem2Cleared 510(K)
- K211657EMPHASYS Femoral Stems2Cleared 510(K)
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads2Cleared 510(K)
- K203175POLARSTEM Cemented Femoral Stem2Cleared 510(K)
- K211548POLARSTEM Calcar Reamer Guide2Cleared 510(K)
- K203532BI-MENTUM™ ALTRX® Dual Mobility Liner2Cleared 510(K)
- K201047Fusion Taper System2Cleared 510(K)
- K202768KOSMO Femoral Stem2Cleared 510(K)
- K203420EcoFit® Hip System2Cleared 510(K)
- K201471M-Vizion Femoral Revision System Extension2Cleared 510(K)
- K202730Quadra-P2Cleared 510(K)
- K200196Taperloc® Complete Hip Stems2Cleared 510(K)
- K203041SMS Cementless Stem2Cleared 510(K)
- K203167DePuy Corail AMT Hip Prosthesis2Cleared 510(K)
- K201673SMS Cementless Stem2Cleared 510(K)
- K192883Spartan Hip Stem2Cleared 510(K)
- K193545Corin Optimized Positioning System (OPS) Femoral2Cleared 510(K)
- K201951Cemented Origin Hip Stem2Cleared 510(K)
- K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling2Cleared 510(K)
- K192024Cemented TSI Hip Stem2Cleared 510(K)
- K191816M-Vizion Femoral Revision System Extension2Cleared 510(K)
- K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar2Cleared 510(K)
- K200112Zimmer Hip Joint Replacement2Cleared 510(K)
- K192660Zimmer M/L Taper Hip Prosthesis2Cleared 510(K)
- K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads2Cleared 510(K)
- K191831MobiliT Cup2Cleared 510(K)
- K193433AMIStem-C2Cleared 510(K)
- K192827Quadra-P2Cleared 510(K)
- K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2Cleared 510(K)
- K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)2Cleared 510(K)
- K192189Avenir Complete Hip System, Size 0 Coxa Vara2Cleared 510(K)
- K193030Avenir Muller Stem, Avenir Cemented Hip Stem2Cleared 510(K)
- K192946DePuy Corail AMT Hip Prosthesis2Cleared 510(K)
- K192126AMIStem-P Short Neck2Cleared 510(K)
- K190344DePuy Corail AMT Hip Prosthesis2Cleared 510(K)
- K190890Exactech Alteon Modular Dual Mobility (MDM) System2Cleared 510(K)
- K191632PROFEMUR TL2 Stems2Cleared 510(K)
- K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System2Cleared 510(K)
- K192352MiniMAX2Cleared 510(K)
- K191399BIOLOX CONTOURA Ceramic Femoral Head2Cleared 510(K)
- K190704Signature Ceramic Femoral Head2Cleared 510(K)
- K183684Libertas – Taper Uncemented Femoral Stem2Cleared 510(K)
- K183312Conformity Stem2Cleared 510(K)
- K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System2Cleared 510(K)
- K190535BiMobile Dual Mobility System - E-Dur Inserts2Cleared 510(K)
- K191374Revival Modular Hip Stem2Cleared 510(K)
- K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)2Cleared 510(K)
- K183532Latitud Hip Replacement System2Cleared 510(K)
- K191145MasterLoc Extension2Cleared 510(K)
- K182321MobileLink Acetabular Cup System2Cleared 510(K)
- K181491Delta Dual Mobility System2Cleared 510(K)
- K181171Zimmer Biomet Ceramic Heads2Cleared 510(K)
- K183365Libertas Acetabular Hooded Liner2Cleared 510(K)
- K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups2Cleared 510(K)
- K183141LINK MP Monoblock Hip Prosthesis2Cleared 510(K)
- K183136Zimmer Segmental System Proximal Femoral Component2Cleared 510(K)
- K181761Zimmer Biomet Select Ceramic Heads2Cleared 510(K)
- K181744BI-MENTUM dual mobility system2Cleared 510(K)
- K182048Avenir Complete Hip System2Cleared 510(K)
- K181693SMS Femoral Stem2Cleared 510(K)
- K182462Exactech Alteon Highly Polished Femoral Stem2Cleared 510(K)
- K181254Quadra P2Cleared 510(K)
- K173960DePuy Corail AMT Hip Prosthesis2Cleared 510(K)
- K173898MicroPort Orthopedics Total Hip Systems MR Labeling2Cleared 510(K)
- K181598Prime E-CLASS XLPE Liner2Cleared 510(K)
- K181061Corin Optimized Positioning System (OPS) Femoral2Cleared 510(K)
- K181532Exactech Alteon Monobloc Revision Stem2Cleared 510(K)
- K173380b-ONE® Total Hip System2Cleared 510(K)
- K180263EcoFit Vit E Acetabular System2Cleared 510(K)
- K173776BIOLOX delta Option and Extra-long Heads2Cleared 510(K)
- K180929Klassic HD® Hip System2Cleared 510(K)
- K170339Summit Hip System2Cleared 510(K)
- K172235CoreHip® System2Cleared 510(K)
- K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared2Cleared 510(K)
- K172467OMNI ARC Anteverted Neck Hip Stem2Cleared 510(K)
- K173267MasterLoc Stem: Lateralized Plus2Cleared 510(K)
- K170690M-Vizion Femoral Revision System2Cleared 510(K)
- K170473C2 femoral stem2Cleared 510(K)
- K170359Trinity™ Dual Mobility System2Cleared 510(K)
- K170089U-Motion II Acetabular System— Additional sizes2Cleared 510(K)
- K163577Ecofit® Hip System2Cleared 510(K)
- K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner2Cleared 510(K)
- K163441Locking Cage, Full XPE Cup2Cleared 510(K)
- K171156OMNI Anseris Hip Stem2Cleared 510(K)
- K170845MiniMAX2Cleared 510(K)
- K162942Corin MetaFix Hip Stem2Cleared 510(K)
- K163585Responsive Orthopedics Total Hip Arthroplasty System2Cleared 510(K)
- K161635AMIStem-H Proximal Coating2Cleared 510(K)
- K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated2Cleared 510(K)
- K161226Revision Femoral Stem2Cleared 510(K)
- K160895Initia Total Hip System & BIOCERAM AZUL(R) HEAD2Cleared 510(K)
- K161830Zimmer M/L Taper Hip Prosthesis2Cleared 510(K)
- K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System2Cleared 510(K)
- K152893Corin Optimized Positioning System (OPS)2Cleared 510(K)
- K160289MasterLoc Stem2Cleared 510(K)
- K152903REVIVAL(TM) Modular Revision Hip Stem2Cleared 510(K)
- K152530UCP Stem2Cleared 510(K)
- K152919OMNI Skirted Heads2Cleared 510(K)
- K151307ICONACY(TM) I-Hip (TM)2Cleared 510(K)
- K153381Corin Metafix Hip Stem2Cleared 510(K)
- K151739Revision Femoral Stem2Cleared 510(K)
- K151531MasterLoc Stem2Cleared 510(K)
- K150576TGM Biolox delta Ceramic Heads2Cleared 510(K)
- K151902REDAPT¿ Revision Femoral System2Cleared 510(K)
- K150066Exactech Alteon Monobloc Revision Stem2Cleared 510(K)
- K150133PROFEMUR Preserve Size 1-3 Hip Stems2Cleared 510(K)
- K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA2Cleared 510(K)
- K150302PROFEMUR Preserve Classic Stem2Cleared 510(K)
- K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA2Cleared 510(K)
- K150062Excia Total Hip System2Cleared 510(K)
- K143509MasterSL femoral stem2Cleared 510(K)
- K142675CI../..X liner for NOVAE Dual Mobility Acetabular Cup2Cleared 510(K)
- K143407Klassic HD Hip System2Cleared 510(K)
- K141377BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD2Cleared 510(K)
- K142187LINK MP RECONSTRUCTION PROSTHESIS2Cleared 510(K)
- K141235PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS2Cleared 510(K)
- K141821ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET2Cleared 510(K)
- K141653BIOLOX DELTA CERAMIC OPTION HEADS2Cleared 510(K)
- K141327MINIMA S SYSTEM2Cleared 510(K)
- K140915EXCIA TOTAL HIP SYSTEM2Cleared 510(K)
- K140674EXACTECH TAPERED WEDGE FEMORAL STEM2Cleared 510(K)
- K140975MASTERSL FEMORAL STEM2Cleared 510(K)
- K140676PROFEMUR TL CLASSIC LONG NECK HIP STEMS2Cleared 510(K)
- K140043DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD2Cleared 510(K)
- K133381OMNI ARC MONOBLOCK HIP STEM2Cleared 510(K)
- K131986CORIN MINIHIP STEM2Cleared 510(K)
- K131952CORIN METAFIX HIP STEM2Cleared 510(K)
- K131518MECTACER BIOLOX OPTION HEADS2Cleared 510(K)
- K132435SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS2Cleared 510(K)
- K131684BIOLOX(R) DELTA CERAMIC HEADS2Cleared 510(K)
- K130728POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA2Cleared 510(K)
- K131458MPACT DM LINER CONVERTER2Cleared 510(K)
- K131647TRINITY ACETABULAR SYSTEM2Cleared 510(K)
- K132455U-MOTION II PS+ CUP2Cleared 510(K)
- K131884AVENIR CEMENTED HIP STEM2Cleared 510(K)
- K130376DYNASTY ACETABULAR SYSTEM WITH CERAMIC2Cleared 510(K)
- K130343CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS2Cleared 510(K)
- K130984PROFEMUR RENAISSANCE CLASSIC HIP STEM2Cleared 510(K)
- K130634CORIN METAFIX HIP STEM2Cleared 510(K)
- K123619INTRABLOCK BIOBALL HIP SYSTEM (IBS)2Cleared 510(K)
- K130899BIOLOX DELTA CERAMIC FEMORAL HEADS2Cleared 510(K)
- K130167PROFEMUR XM DISTAL CENTRALIZER2Cleared 510(K)
- K123782PARAGON HIP SYSTEM2Cleared 510(K)
- K130128TRINITY ACETABULAR SYSTEM2Cleared 510(K)
- K123392AVENIR MULLER STEM2Cleared 510(K)
- K123924DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS2Cleared 510(K)
- K122185U-MOTION II ACETABULAR SYSTEM2Cleared 510(K)
- K123705TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS2Cleared 510(K)
- K123688PROFEMUR TL CLASSIC HIP STEM2Cleared 510(K)
- K123434PROFEMUR Z CLASSIC STEMS2Cleared 510(K)
- K121392NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE2Cleared 510(K)
- K122305CORIN TRINITY-I ACETABULAR SHELL2Cleared 510(K)
- K122911VERSAFITCUP CC TRIO EXTENSION2Cleared 510(K)
- K111981TREGOR DUAL MOBILITY ACETABULAR SYSTEM2Cleared 510(K)
- K122641MPACT EXTENSION2Cleared 510(K)
- K121665BENCOX FORET & BENCOX DELTA2Cleared 510(K)
- K121439METAFIX FEMORAL HIP STEM SIZE 12Cleared 510(K)
- K122296SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING2Cleared 510(K)
- K121221PROFEMUR Z REVISION HIP STEM2Cleared 510(K)
- K120211SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING2Cleared 510(K)
- K121011AMISTEM AND QUADRA - LINE EXTENSION2Cleared 510(K)
- K120362METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY2Cleared 510(K)
- K120531VERSAFITCUP CC TRIO-ADDITIONAL LINERS2Cleared 510(K)
- K112682METHA HIP SYSTEM2Cleared 510(K)
- K113556WAGNER CONE PROSTHESIS SYSTEM2Cleared 510(K)
- K112115MECTACER BIOLOX(R) DELTA FEMORAL HEADS2Cleared 510(K)
- K112463UNITED 36MM CERAMIC FEMORAL HEAD, DELTA2Cleared 510(K)
- K111936ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD2Cleared 510(K)
- K111572NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL2Cleared 510(K)
- K111046CORIN MINIHIP FEMORAL STEM2Cleared 510(K)
- K111193APEX ARC HIP STEM2Cleared 510(K)
- K110087CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS2Cleared 510(K)
- K110101TAPER OXINIUM FEMORAL HEAD2Cleared 510(K)
- K093736DEPUY CORAIL HIP SYSTEM, REVISION STEM2Cleared 510(K)
- K103120CORIN BIOLOX DELTA FEMORAL HEADS2Cleared 510(K)
- K103352VERSAFITCUP CC TRIO2Cleared 510(K)
- K103233MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT2Cleared 510(K)
- K101472MULTIFIT TOTAL HIP SYSTEM2Cleared 510(K)
- K103189MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK2Cleared 510(K)
- K102080DEPUY RECLAIM REVISION HIP SYSTEM2Cleared 510(K)
- K103012EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS2Cleared 510(K)
- K102487NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/202Cleared 510(K)
- K101296ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS2Cleared 510(K)
- K101451APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD2Cleared 510(K)
- K100008CARDO MEDICAL CERAMIC HIP SYSTEM2Cleared 510(K)
- K100412BIOLOX DELTA CERAMIC FEMORAL HEADS2Cleared 510(K)
- K100866PROFEMUR HIP SYSTEM MODULAR NECKS2Cleared 510(K)
- K093991SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS2Cleared 510(K)
- K090845APEX ARC HIP STEM2Cleared 510(K)
- K083312MINIHIP STEM2Cleared 510(K)
- K093846LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS2Cleared 510(K)
- K082525CORIN METAFIX FEMORAL STEM2Cleared 510(K)
- K093944MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S2Cleared 510(K)
- K09354944MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM2Cleared 510(K)
- K090299BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS2Cleared 510(K)
- K083762BIOLOX DELTA CERAMIC FEMORAL HEADS2Cleared 510(K)
- K083558MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C2Cleared 510(K)
- K082371SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM2Cleared 510(K)
- K083495MODIFICATION TO: METHA HIP SYSTEM2Cleared 510(K)
- K082996BIOLOX DELTA OPTION CERAMIC HEADS2Cleared 510(K)
- K083392NOVATION 12/14 CEMENTED FEMORAL STEMS2Cleared 510(K)
- K082844BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE2Cleared 510(K)
- K082991BIOLOX DELTA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K082398ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS2Cleared 510(K)
- K081860ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS2Cleared 510(K)
- K081973METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM2Cleared 510(K)
- K072852SL-PLUS STANDARD AND LATERAL HIP STEMS2Cleared 510(K)
- K073567BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES2Cleared 510(K)
- K073570DEPUY TRI-LOCK BONE PRESERVATION STEM2Cleared 510(K)
- K073337MECTACER BIOLOX FORTE-FEMORAL HEADS2Cleared 510(K)
- K072656DYNASTY CERAMIC FEMORAL HEAD2Cleared 510(K)
- K073102BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS2Cleared 510(K)
- K071535BIOLOX DELTA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K071830DEPUY DELTA TS CERAMIC FEMORAL HEADS2Cleared 510(K)
- K071082STRYKER MODULAR HIP SYSTEM2Cleared 510(K)
- K070554DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS2Cleared 510(K)
- K070928CERAMIC BALL HEADS, 28, 32 AND 36 MM2Cleared 510(K)
- K070885UNIVERSAL TAPER DELTA FEMORAL HEAD2Cleared 510(K)
- K070479EXACTECH NOVATION CROWN CUP AND LINERS2Cleared 510(K)
- K063816PCA ALUMINA FEMORAL HEADS2Cleared 510(K)
- K063616TRIDENT II ACETABULAR SYSTEM2Cleared 510(K)
- K062997ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS2Cleared 510(K)
- K062748MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K063279NOVATION SPLINED RDD FEMORAL STEMS2Cleared 510(K)
- K062684EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD2Cleared 510(K)
- K061564PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD2Cleared 510(K)
- K061066SYNERGY HIP SYSTEM2Cleared 510(K)
- K053246PATIENT MATCHED HIP STEM2Cleared 510(K)
- K06131236MM BIOLOX DELTA CERAMIC HEADS2Cleared 510(K)
- K060918EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD2Cleared 510(K)
- K051223HIPSTAR FEMORAL STEM2Cleared 510(K)
- K060577ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS2Cleared 510(K)
- K053587ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS2Cleared 510(K)
- K060107MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS2Cleared 510(K)
- K052787ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)2Cleared 510(K)
- K052275SMITH & NEPHEW PLATFORM HIP STEM2Cleared 510(K)
- K051858ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM2Cleared 510(K)
- K050398EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS2Cleared 510(K)
- K052718V40 BIOLOX DELTA CERAMIC FEMORAL HEADS2Cleared 510(K)
- K052542ACCOLADE RPS HIP STEM2Cleared 510(K)
- K051741ACCOLADE HFX FEMORAL STEM2Cleared 510(K)
- K052237SC CERAMIC BALL HEADS2Cleared 510(K)
- K051737MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE2Cleared 510(K)
- K051738SECUR-FIT MAX AND PLUS MAX HIP STEMS2Cleared 510(K)
- K051682EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM2Cleared 510(K)
- K051588BIOLOX DELTA CERAMIC FEMORAL HEADS2Cleared 510(K)
- K051411ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS2Cleared 510(K)
- K050556ALUMINA HEAD2Cleared 510(K)
- K043356WAGNER SL REVISION STEM LATERAL2Cleared 510(K)
- K042091BIOLOX DELTA CERAMIC HEADS2Cleared 510(K)
- K042992CORAIL AMT HIP PROSTHESIS2Cleared 510(K)
- K041940HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS2Cleared 510(K)
- K042035ALUMINA HEAD2Cleared 510(K)
- K041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM2Cleared 510(K)
- K042842NOVATION 12/14 PRESS-FIT FEMORAL STEM2Cleared 510(K)
- K041170SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS2Cleared 510(K)
- K042249CLS SPOTORNO STEM2Cleared 510(K)
- K040734MODIFICATION TO RESTORATION MODULAR SYSTEM2Cleared 510(K)
- K040803MS-30 FEMORAL STEM STANDARD AND LATERAL2Cleared 510(K)
- K040644MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD2Cleared 510(K)
- K033944STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD2Cleared 510(K)
- K033664MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM2Cleared 510(K)
- K032348CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP2Cleared 510(K)
- K032380WAGNER CONE PROSTHESIS2Cleared 510(K)
- K031803DEPUY CERAMIC FEMORAL HEADS2Cleared 510(K)
- K030724ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM2Cleared 510(K)
- K031217GMRS PRESS FIT STEMS WITH PUREFIX HA2Cleared 510(K)
- K030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM2Cleared 510(K)
- K030373ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM2Cleared 510(K)
- K023901ALUMINA V40 FEMORAL HEADS2Cleared 510(K)
- K022985ASCENDENT ACETABULAR SYSTEM2Cleared 510(K)
- K022403GMRS PRESS FIT STEMS WITH PUREFIX HA2Cleared 510(K)
- K022549RESTORATION MODULAR SYSTEM2Cleared 510(K)
- K022555ACCOLADE C FEMORAL STEMS2Cleared 510(K)
- K022120MPF ACETABULAR CUP GENERATION 22Cleared 510(K)
- K021673TOTAL HIP FEMORAL HEAD - 12/14 TAPER2Cleared 510(K)
- K020713MS-30 LATERAL FEMORAL STEM2Cleared 510(K)
- K0131062 PIECE MODULAR HIP STEM2Cleared 510(K)
- K011533DEPUY FEMORAL HEADS2Cleared 510(K)
- K013989ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER2Cleared 510(K)
- K013935ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS2Cleared 510(K)
- K012918APEX MODULAR ALUMINA FEMORAL HEAD2Cleared 510(K)
- K012091PRO-FEMUR2Cleared 510(K)
- K011836MPF ACETABULAR CUP2Cleared 510(K)
- K010839CLS VARUS STEM/CLS 135 STEM2Cleared 510(K)
- K003274LPC-PLUS ACETABULAR CUP2Cleared 510(K)
- K010560PORTRAIT FEMORAL COMPONENT2Cleared 510(K)
- K003923APEX MODULAR ZIRCONIA FEMORAL HEAD2Cleared 510(K)
- K003316OTI CERAMIC FEMORAL HEAD SYSTEM2Cleared 510(K)
- K003379V-40/C-TAPER ADAPTER SLEEVE2Cleared 510(K)
- K003391OSTEONICS ALUMINA C-TAPER HEAD2Cleared 510(K)
- K003413ALUMINA V40 HEAD2Cleared 510(K)
- K002320ACCOLADE C FEMORAL COMPONENT2Cleared 510(K)
- K002441FENNING HIP STEM2Cleared 510(K)
- K001449TRIDENT ACETABULAR SHELLS: PS2Cleared 510(K)
- K993874BOFOR REVISION COUP2Cleared 510(K)
- K000432RESPONSE 2000 CEMENTED HIP STEM2Cleared 510(K)
- K000392RESPONSE 2000 HIP STEM2Cleared 510(K)
- K992359MRS-TITAN2Cleared 510(K)
- K994184PLR SPLINED REVISION STEM2Cleared 510(K)
- K993889EXETER CERAMIC FEMORAL HEADS2Cleared 510(K)
- K991162BIOLOX ALUMINA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K992403MRP-TITAN2Cleared 510(K)
- K993043MS-30 FEMORAL STEM2Cleared 510(K)
- K992235ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS2Cleared 510(K)
- K992144BIOPRO RIMMED ACETABULAR COMPOMENT2Cleared 510(K)
- K990261PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)2Cleared 510(K)
- K991708ZIRCONIA 22.22MM CERAMIC MODULAR HEADS2Cleared 510(K)
- K991952OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS2Cleared 510(K)
- K990183IMPLEX ALUMINA FEMORAL HEAD2Cleared 510(K)
- K991226FOUNDATION POROUS HIP STEM2Cleared 510(K)
- K983404TYPE 3 FEMORAL COMPONENTS2Cleared 510(K)
- K981847BIOLOX ALUMINA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K981302SMC 28MM CERAMIC FEMORAL HEADS2Cleared 510(K)
- K981201OSTEOLOCK ACETABULAR CUP2Cleared 510(K)
- K980774OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS2Cleared 510(K)
- K980473PRESS-FIT STEM2Cleared 510(K)
- K980239PARTNERSHIP CALCAR FEMORAL COMPONENTS2Cleared 510(K)
- K980081S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD2Cleared 510(K)
- K973837CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL2Cleared 510(K)
- K973681NATURAL-HIP COCR OFFSET STEM2Cleared 510(K)
- K972228MERIDIAN TITANIUM FEMORAL STEMS2Cleared 510(K)
- K973261WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD2Cleared 510(K)
- K973307S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD2Cleared 510(K)
- K973087MOST HEX INTRAMEDULLARY (I/M) STEM2Cleared 510(K)
- K972893PARTNERSHIP REVISION FEMORAL STEMS2Cleared 510(K)
- K972690ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K972637PRECEDENT REVISION HIP SYSTEM2Cleared 510(K)
- K972361V40 ZIRCONIA FEMORAL HEADS2Cleared 510(K)
- K970675HEADLOC CERAMIC HEAD2Cleared 510(K)
- K964431ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)2Cleared 510(K)
- K971752ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)2Cleared 510(K)
- K971721WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K971497OSTEONICS ANTEVERTED NECK HIP STEM2Cleared 510(K)
- K971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS2Cleared 510(K)
- K971435HEADLOC CERAMIC FEMORAL HEADS2Cleared 510(K)
- K971426HEADLOC CERAMIC HEAD2Cleared 510(K)
- K971409OSTEONICS ALUMINA C-TAPER HEAD2Cleared 510(K)
- K965002ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND2Cleared 510(K)
- K97084622.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD2Cleared 510(K)
- K970490PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT2Cleared 510(K)
- K970200RELIANCE PF FEMORAL STEMS2Cleared 510(K)
- K970166NATURAL-HIP SYSTEM COCR REVISION STEM2Cleared 510(K)
- K970346PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT2Cleared 510(K)
- K964395PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT2Cleared 510(K)
- K964357NATURAL-HIP SYSTEM COCR STEM2Cleared 510(K)
- K964704DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM2Cleared 510(K)
- K964249BRIDGE LONG STEM FEMORAL COMPONENT2Cleared 510(K)
- K964150WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K953111CORAIL2Cleared 510(K)
- K955877ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K962248P.F.C. CERAMIC HIP HEAD2Cleared 510(K)
- K962101ZWEYMUELLER SL FEMORAL HIP STEM2Cleared 510(K)
- K961921APR OVERSIZED HIP STEM2Cleared 510(K)
- K960588WAGNER REVISION STEM2Cleared 510(K)
- K961727NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM2Cleared 510(K)
- K961589APR FULLY TEXTURED HIP STEM2Cleared 510(K)
- K953690CLS STEM (MODIFICATION)2Cleared 510(K)
- K955117IMPLEX CERAMIC HEAD2Cleared 510(K)
- K955386CONSENSUS ZIRCONIA FEMORAL HEAD2Cleared 510(K)
- K955350BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM2Cleared 510(K)
- K953925FINE GRAIN CAST COBALT CHROMIUM HIP STEMS2Cleared 510(K)
- K954768BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD2Cleared 510(K)
- K953689WAGNER REVISION STEM (MODIFICATION)2Cleared 510(K)
- K953688CLS ACETABULAR COMPONENT (MODIFICATION)2Cleared 510(K)
- K953792CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +52Cleared 510(K)
- K944689ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K953045BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD2Cleared 510(K)
- K952686BUCHALTER FAUSER FEMORAL COMPONENTS2Cleared 510(K)
- K953169STELKAST ALL POLYETHYLENE ACETABULAR CUP2Cleared 510(K)
- K952418V40 ZIRCONIA FEMORAL HEADS2Cleared 510(K)
- K952088ZIRCONIA ARTICUL/EZE FEMORAL BALLS2Cleared 510(K)
- K946026HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS2Cleared 510(K)
- K943774OSTEONICS RESTORATION MONOLITHIC HIP STEM2Cleared 510(K)
- K945516NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM2Cleared 510(K)
- K945093P.C.A. E-SERIES HIP- CEMENTLESS USE2Cleared 510(K)
- K945092P.C.A.PRIMARY HIP- CEMENTLESS USE2Cleared 510(K)
- K945090HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K945089SENTRY TOTAL HIP2Cleared 510(K)
- K945096CDH HIP STEM2Cleared 510(K)
- K945094HNR-PC HIP2Cleared 510(K)
- K945095APC FEMORAL COMPONENT2Cleared 510(K)
- K945091HOWMEDICA ALUMINA FEMORAL HEAD2Cleared 510(K)
- K944601ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K935913HOWMEDICA SENTRY S TOTAL HIP SYSTEM2Cleared 510(K)
- K944209APR II NON POROUS HIP STEM2Cleared 510(K)
- K935921ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K936256MODULAR CERAMIC FEMORAL HEAD2Cleared 510(K)
- K943586ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)2Cleared 510(K)
- K933942SOLUTION BOWED FEMORAL HIP PROTSTHESIS2Cleared 510(K)
- K935452P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT2Cleared 510(K)
- K942330APR II FEMORAL COMPONENT (VARIOUS)2Cleared 510(K)
- K933275P.F.C. CERAMIC HIP HEAD2Cleared 510(K)
- K933108TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS2Cleared 510(K)
- K935193CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM2Cleared 510(K)
- K941942SOLUTION HIP2Cleared 510(K)
- K9418475/8 POROCOAT AML HIP POROCOAT POROUS COATING2Cleared 510(K)
- K934457STABILITY HIP STEM WITH POROCOAT2Cleared 510(K)
- K935185MORPHOMETRIC TOTAL HIP PROSTHESIS2Cleared 510(K)
- K932935TITAN DYSPLASIC TOTAL HIP PROSTHESIS2Cleared 510(K)
- K931617EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT2Cleared 510(K)
- K932222SLT FEMORAL HEAD2Cleared 510(K)
- K934694KIRSCHNER ZIRCONIA FEMORAL HEAD2Cleared 510(K)
- K933499CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM2Cleared 510(K)
- K933567EUROFORM TOTAL HIP PROSTHESIS2Cleared 510(K)
- K933203APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP2Cleared 510(K)
- K931571LINK CERAMIC HEADS 12/14 X 32MM2Cleared 510(K)
- K922247KINAMED REALITY TOTAL HIP SYSTEM2Cleared 510(K)
- K931929TECHMEDICA CONTINUUM HIP SYSTEM2Cleared 510(K)
- K931572LINK CERAMIC HEADS 14/16 X 32MM2Cleared 510(K)
- K932519OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM2Cleared 510(K)
- K926395ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM2Cleared 510(K)
- K925345ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)2Cleared 510(K)
- K930788ZIRCONIA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K921224BIMETRIC TOTAL HIP SYSTEM2Cleared 510(K)
- K921225INTEGRAL TOTAL HIP SYSTEM2Cleared 510(K)
- K921181MALLORY-HEAD TOTAL HIP SYSTEM2Cleared 510(K)
- K931189P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET2Cleared 510(K)
- K930963SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS2Cleared 510(K)
- K925682BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED2Cleared 510(K)
- K930712P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR2Cleared 510(K)
- K923808MULLER STRAIGHT STEM FEMORAL PROSTHESIS2Cleared 510(K)
- K915222WALKER HIP PROSTHESIS2Cleared 510(K)
- K923734TOTAL HIP PROTHESIS FEMORAL COMPONENT2Cleared 510(K)
- K920968INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD2Cleared 510(K)
- K925695OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD2Cleared 510(K)
- K925512CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION2Cleared 510(K)
- K923583ORTHOMET PERFECTA TOTAL HIP SYSTEM2Cleared 510(K)
- K921836PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD2Cleared 510(K)
- K915641ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER2Cleared 510(K)
- K920290KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL2Cleared 510(K)
- K920219KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL2Cleared 510(K)
- K921111S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD2Cleared 510(K)
- K915396OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD2Cleared 510(K)
- K920145BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K920593CERAMIC FEMORAL HEAD2Cleared 510(K)
- K920756FELDMUHLE CERAMIC HEAD2Cleared 510(K)
- K920577HOWEDICA ZIRCONIA FEMORAL HEAD2Cleared 510(K)
- K915310KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL2Cleared 510(K)
- K915309KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL2Cleared 510(K)
- K915184HOWMEDICA ALUMINA FEMORAL HEAD2Cleared 510(K)
- K913420ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF2Cleared 510(K)
- K914676ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER2Cleared 510(K)
- K914574EXACTECH CERAMIC FEMORAL HEAD COMPONENT2Cleared 510(K)
- K912985LIMA 28MM CERAMIC HEAD, MODIFICATION2Cleared 510(K)
- K914237KINAMED CTN STEM2Cleared 510(K)
- K912641BIOPRO ZIRALLOY MODULAR FEMORAL HEADS2Cleared 510(K)
- K913633TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS2Cleared 510(K)
- K912295KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL2Cleared 510(K)
- K905687ZIRCONIA CERAMIC MODULAR HEADS2Cleared 510(K)
- K910547FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)2Cleared 510(K)
- K910548FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)2Cleared 510(K)
- K905739ZIMMER CERAMIC FEMORAL HEADS2Cleared 510(K)
- K905260TOTAL HIP FEMORAL COMPONENT2Cleared 510(K)
- K904028DCW MODULAR PROXIMAL FEMORAL SYSTEM2Cleared 510(K)
- K903976CTH STABILO TOTAL HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K902712OSTEONICS PS HEAD AND NECK HIP STEM SERIES2Cleared 510(K)
- K902073KINAMED CEMENTED ATH-LONG STEM2Cleared 510(K)
- K902074KINAMED CEMENTED CTH STEM2Cleared 510(K)
- K896850LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE2Cleared 510(K)
- K900628MODULAR HIP SYSTEM2Cleared 510(K)
- K894904KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL2Cleared 510(K)
- K896669WEBER PERMALOCK2Cleared 510(K)
- K895399KIM MODULAR FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K896204ZIRCONIA CERAMIC HEAD ADD'L SIZES2Cleared 510(K)
- K892644BIOLOX CERAMIC BALL2Cleared 510(K)
- K894694OMNIFIT CERAMIC MORSE TAPER HEAD2Cleared 510(K)
- K893685CERAMIC FEMORAL HEAD2Cleared 510(K)
- K890472ATH CERAMIC UHMWPE TOTAL HIP SYSTEM2Cleared 510(K)
- K885069ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)2Cleared 510(K)
- K885102OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)2Cleared 510(K)
- K891082CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER2Cleared 510(K)
- K891083CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER2Cleared 510(K)
- K884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC2Cleared 510(K)
- K890060CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER2Cleared 510(K)
- K861400THREADED TITANIUM METAL BACKED ACETABULAR CUP2Cleared 510(K)
- K860275TI-FIT ACETABULAR COMPONENT2Cleared 510(K)
- K844906THREADED TITANIUM METAL BACKED ACETABULAR CUP2Cleared 510(K)
- 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
TGM Biolox delta Ceramic Heads
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150576
- 510(k) Type
- Traditional
- Applicant
- TGM MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/9/2015
- Days to Decision
- 187 days
- Submission Type
- Summary