BEUDAMED
    Product Code: LZO FDA class 2 21 CFR 888.3353

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    Orthopedic

    The Cemented or Non-Porous Uncemented Semi-Constrained Metal/Ceramic/Polymer Hip Prosthesis (product code LZO) is an orthopedic implant used to replace the hip joint using a metal, ceramic, and polymer composite construct available in cemented or non-porous uncemented configurations. Regulated under 21 CFR 888.3353 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the Orthopedic specialty. It is not life-sustaining.

    View on FDA
    510(k)s
    523
    FEI Numbers
    284
    Registration Numbers
    284
    Unique Applicants
    149
    Years Active
    40

    Basic Information

    Product Code
    LZO
    Device Class
    FDA class 2
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 523 510(k) clearances via K numbers.

    K Number Device Name
    K251292 RECLAIM Monobloc Revision Femoral Stem
    K243927 MobileLink Acetabular Cup System - inhouse coatings
    K250444 NEXUS® Hip Stem
    K243043 Origin™ Cemented Hip Stem
    K250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)
    K250571 CATALYSTEM Femoral Stems
    K243029 Origin™ TT Stem
    K241767 Versacem Acetabular Shell and Double Mobility HC Liners
    K243809 Biolox® Delta Revision heads
    K241483 ceramys™ femoral head system
    K243466 Conformity Stem Extension Line, #0
    K243444 BIOCERAM AZUL® HEAD
    K240528 b-ONE® Total Hip System
    K240391 MUTARS® femoral stem cemented 160 mm and 200 mm
    K242249 Conformity Stem Extension Line
    K241241 Z1 Cemented Hip System
    K240381 CATALYSTEM Femoral Stems
    K240834 EcoFit® short stem cementless cpTi
    K234025 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
    K240452 Ceramic Femoral Head
    K233724 28mm/38D MDM X3 Insert for MDM Liner
    K233476 Z1 Hip System
    K223745 Novae® Dual Mobility System, Hype® Hip System
    K232371 Actinia® hip stems
    K233233 EMPHASYS Femoral Stems
    K231925 MINIMA S System
    K223103 BethaLoc® stem cementless HA
    K231109 Xerxes Hip Stem
    K221323 Exactech® Alteon® Short Tapered Wedge
    K223828 BENCOX Delta Option Heads
    K222296 ARTICUL/EZE Ceramic Heads
    K221149 U-Motion II Acetabular System-Extension line
    K221462 DePuy Reclaim Monobloc Revision Femoral Stem
    K220483 Platform® Acetabular System
    K213770 SP-CL Hip Stem and LCU Hip System
    K210678 implaFit® hip stems
    K211891 DM Converter - TiN coated
    K211567 BiMobile Instruments (for BiMobile Dual Mobility System)
    K212327 M-Vizion Monobloc
    K220405 Amis K Long
    K213675 MP Reconstruction System
    K212069 Corin MetaFix™ Hip Stem
    K213839 DePuy Corail AMT Hip Prosthesis
    K213129 Restoration Modular 115mm Conical Distal Stem
    K213580 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length
    K210263 Mpres Neck Preserving Stem
    K211657 EMPHASYS Femoral Stems
    K201657 Corin 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 Heads
    K203175 POLARSTEM Cemented Femoral Stem
    K211548 POLARSTEM Calcar Reamer Guide
    K203532 BI-MENTUM™ ALTRX® Dual Mobility Liner
    K201047 Fusion Taper System
    K202768 KOSMO Femoral Stem
    K203420 EcoFit® Hip System
    K201471 M-Vizion Femoral Revision System Extension
    K202730 Quadra-P
    K200196 Taperloc® Complete Hip Stems
    K203041 SMS Cementless Stem
    K203167 DePuy Corail AMT Hip Prosthesis
    K201673 SMS Cementless Stem
    K192883 Spartan Hip Stem
    K193545 Corin Optimized Positioning System (OPS) Femoral
    K201951 Cemented Origin Hip Stem
    K200959 Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
    K192024 Cemented TSI Hip Stem
    K191816 M-Vizion Femoral Revision System Extension
    K200007 PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
    K200112 Zimmer Hip Joint Replacement
    K192660 Zimmer M/L Taper Hip Prosthesis
    K192683 Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
    K191831 MobiliT Cup
    K193433 AMIStem-C
    K192827 Quadra-P
    K193050 Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
    K192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)
    K192189 Avenir Complete Hip System, Size 0 Coxa Vara
    K193030 Avenir Muller Stem, Avenir Cemented Hip Stem
    K192946 DePuy Corail AMT Hip Prosthesis
    K192126 AMIStem-P Short Neck
    K190344 DePuy Corail AMT Hip Prosthesis
    K190890 Exactech Alteon Modular Dual Mobility (MDM) System
    K191632 PROFEMUR TL2 Stems
    K192416 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
    K192352 MiniMAX
    K191399 BIOLOX CONTOURA Ceramic Femoral Head
    K190704 Signature Ceramic Femoral Head
    K183684 Libertas – Taper Uncemented Femoral Stem
    K183312 Conformity Stem
    K191781 Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
    K190535 BiMobile Dual Mobility System - E-Dur Inserts
    K191374 Revival Modular Hip Stem
    K190834 Corin Optimized Position System Functional Hip Analysis (OPS FHA)
    K183532 Latitud Hip Replacement System
    K191145 MasterLoc Extension
    K182321 MobileLink Acetabular Cup System
    K181491 Delta Dual Mobility System
    K181171 Zimmer Biomet Ceramic Heads
    K183365 Libertas Acetabular Hooded Liner
    K182705 Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
    K183141 LINK MP Monoblock Hip Prosthesis
    K183136 Zimmer Segmental System Proximal Femoral Component
    K181761 Zimmer Biomet Select Ceramic Heads
    K181744 BI-MENTUM dual mobility system
    K182048 Avenir Complete Hip System
    K181693 SMS Femoral Stem
    K182462 Exactech Alteon Highly Polished Femoral Stem
    K181254 Quadra P
    K173960 DePuy Corail AMT Hip Prosthesis
    K173898 MicroPort Orthopedics Total Hip Systems MR Labeling
    K181598 Prime E-CLASS XLPE Liner
    K181061 Corin Optimized Positioning System (OPS) Femoral
    K181532 Exactech Alteon Monobloc Revision Stem
    K173380 b-ONE® Total Hip System
    K180263 EcoFit Vit E Acetabular System
    K173776 BIOLOX delta Option and Extra-long Heads
    K180929 Klassic HD® Hip System
    K170339 Summit Hip System
    K172235 CoreHip® System
    K173794 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
    K172467 OMNI ARC Anteverted Neck Hip Stem
    K173267 MasterLoc Stem: Lateralized Plus
    K170690 M-Vizion Femoral Revision System
    K170473 C2 femoral stem
    K170359 Trinity™ Dual Mobility System
    K170089 U-Motion II Acetabular System— Additional sizes
    K163577 Ecofit® Hip System
    K171181 PROCOTYL® PRIME E-CLASS™ XLPE Liner
    K163441 Locking Cage, Full XPE Cup
    K171156 OMNI Anseris Hip Stem
    K170845 MiniMAX
    K162942 Corin MetaFix Hip Stem
    K163585 Responsive Orthopedics Total Hip Arthroplasty System
    K161635 AMIStem-H Proximal Coating
    K161840 LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
    K161226 Revision Femoral Stem
    K160895 Initia Total Hip System & BIOCERAM AZUL(R) HEAD
    K161830 Zimmer M/L Taper Hip Prosthesis
    K161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
    K152893 Corin Optimized Positioning System (OPS)
    K160289 MasterLoc Stem
    K152903 REVIVAL(TM) Modular Revision Hip Stem
    K152530 UCP Stem
    K152919 OMNI Skirted Heads
    K151307 ICONACY(TM) I-Hip (TM)
    K153381 Corin Metafix Hip Stem
    K151739 Revision Femoral Stem
    K151531 MasterLoc Stem
    K150576 TGM Biolox delta Ceramic Heads
    K151902 REDAPT¿ Revision Femoral System
    K150066 Exactech Alteon Monobloc Revision Stem
    K150133 PROFEMUR Preserve Size 1-3 Hip Stems
    K143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
    K150302 PROFEMUR Preserve Classic Stem
    K143096 SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
    K150062 Excia Total Hip System
    K143509 MasterSL femoral stem
    K142675 CI../..X liner for NOVAE Dual Mobility Acetabular Cup
    K143407 Klassic HD Hip System
    K141377 BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
    K142187 LINK MP RECONSTRUCTION PROSTHESIS
    K141235 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
    K141821 ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET
    K141653 BIOLOX DELTA CERAMIC OPTION HEADS
    K141327 MINIMA S SYSTEM
    K140915 EXCIA TOTAL HIP SYSTEM
    K140674 EXACTECH TAPERED WEDGE FEMORAL STEM
    K140975 MASTERSL FEMORAL STEM
    K140676 PROFEMUR TL CLASSIC LONG NECK HIP STEMS
    K140043 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
    K133381 OMNI ARC MONOBLOCK HIP STEM
    K131986 CORIN MINIHIP STEM
    K131952 CORIN METAFIX HIP STEM
    K131518 MECTACER BIOLOX OPTION HEADS
    K132435 SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
    K131684 BIOLOX(R) DELTA CERAMIC HEADS
    K130728 POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
    K131458 MPACT DM LINER CONVERTER
    K131647 TRINITY ACETABULAR SYSTEM
    K132455 U-MOTION II PS+ CUP
    K131884 AVENIR CEMENTED HIP STEM
    K130376 DYNASTY ACETABULAR SYSTEM WITH CERAMIC
    K130343 CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
    K130984 PROFEMUR RENAISSANCE CLASSIC HIP STEM
    K130634 CORIN METAFIX HIP STEM
    K123619 INTRABLOCK BIOBALL HIP SYSTEM (IBS)
    K130899 BIOLOX DELTA CERAMIC FEMORAL HEADS
    K130167 PROFEMUR XM DISTAL CENTRALIZER
    K123782 PARAGON HIP SYSTEM
    K130128 TRINITY ACETABULAR SYSTEM
    K123392 AVENIR MULLER STEM
    K123924 DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
    K122185 U-MOTION II ACETABULAR SYSTEM
    K123705 TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
    K123688 PROFEMUR TL CLASSIC HIP STEM
    K123434 PROFEMUR Z CLASSIC STEMS
    K121392 NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE
    K122305 CORIN TRINITY-I ACETABULAR SHELL
    K122911 VERSAFITCUP CC TRIO EXTENSION
    K111981 TREGOR DUAL MOBILITY ACETABULAR SYSTEM
    K122641 MPACT EXTENSION
    K121665 BENCOX FORET & BENCOX DELTA
    K121439 METAFIX FEMORAL HIP STEM SIZE 1
    K122296 SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
    K121221 PROFEMUR Z REVISION HIP STEM
    K120211 SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
    K121011 AMISTEM AND QUADRA - LINE EXTENSION
    K120362 METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
    K120531 VERSAFITCUP CC TRIO-ADDITIONAL LINERS
    K112682 METHA HIP SYSTEM
    K113556 WAGNER CONE PROSTHESIS SYSTEM
    K112115 MECTACER BIOLOX(R) DELTA FEMORAL HEADS
    K112463 UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
    K111936 ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
    K111572 NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
    K111046 CORIN MINIHIP FEMORAL STEM
    K111193 APEX ARC HIP STEM
    K110087 CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
    K110101 TAPER OXINIUM FEMORAL HEAD
    K093736 DEPUY CORAIL HIP SYSTEM, REVISION STEM
    K103120 CORIN BIOLOX DELTA FEMORAL HEADS
    K103352 VERSAFITCUP CC TRIO
    K103233 MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
    K101472 MULTIFIT TOTAL HIP SYSTEM
    K103189 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
    K102080 DEPUY RECLAIM REVISION HIP SYSTEM
    K103012 EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS
    K102487 NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
    K101296 ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
    K101451 APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
    K100008 CARDO MEDICAL CERAMIC HIP SYSTEM
    K100412 BIOLOX DELTA CERAMIC FEMORAL HEADS
    K100866 PROFEMUR HIP SYSTEM MODULAR NECKS
    K093991 SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
    K090845 APEX ARC HIP STEM
    K083312 MINIHIP STEM
    K093846 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
    K082525 CORIN METAFIX FEMORAL STEM
    K093944 MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
    K093549 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
    K090299 BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
    K083762 BIOLOX DELTA CERAMIC FEMORAL HEADS
    K083558 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
    K082371 SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
    K083495 MODIFICATION TO: METHA HIP SYSTEM
    K082996 BIOLOX DELTA OPTION CERAMIC HEADS
    K083392 NOVATION 12/14 CEMENTED FEMORAL STEMS
    K082844 BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
    K082991 BIOLOX DELTA CERAMIC FEMORAL HEAD
    K082398 ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
    K081860 ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS
    K081973 METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM
    K072852 SL-PLUS STANDARD AND LATERAL HIP STEMS
    K073567 BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
    K073570 DEPUY TRI-LOCK BONE PRESERVATION STEM
    K073337 MECTACER BIOLOX FORTE-FEMORAL HEADS
    K072656 DYNASTY CERAMIC FEMORAL HEAD
    K073102 BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
    K071535 BIOLOX DELTA CERAMIC FEMORAL HEAD
    K071830 DEPUY DELTA TS CERAMIC FEMORAL HEADS
    K071082 STRYKER MODULAR HIP SYSTEM
    K070554 DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
    K070928 CERAMIC BALL HEADS, 28, 32 AND 36 MM
    K070885 UNIVERSAL TAPER DELTA FEMORAL HEAD
    K070479 EXACTECH NOVATION CROWN CUP AND LINERS
    K063816 PCA ALUMINA FEMORAL HEADS
    K063616 TRIDENT II ACETABULAR SYSTEM
    K062997 ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
    K062748 MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
    K063279 NOVATION SPLINED RDD FEMORAL STEMS
    K062684 EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
    K061564 PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
    K061066 SYNERGY HIP SYSTEM
    K053246 PATIENT MATCHED HIP STEM
    K061312 36MM BIOLOX DELTA CERAMIC HEADS
    K060918 EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
    K051223 HIPSTAR FEMORAL STEM
    K060577 ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
    K053587 ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
    K060107 MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
    K052787 ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
    K052275 SMITH & NEPHEW PLATFORM HIP STEM
    K051858 ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
    K050398 EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
    K052718 V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
    K052542 ACCOLADE RPS HIP STEM
    K051741 ACCOLADE HFX FEMORAL STEM
    K052237 SC CERAMIC BALL HEADS
    K051738 SECUR-FIT MAX AND PLUS MAX HIP STEMS
    K051737 MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
    K051682 EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
    K051588 BIOLOX DELTA CERAMIC FEMORAL HEADS
    K051411 ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
    K050556 ALUMINA HEAD
    K043356 WAGNER SL REVISION STEM LATERAL
    K042091 BIOLOX DELTA CERAMIC HEADS
    K042992 CORAIL AMT HIP PROSTHESIS
    K041940 HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
    K042035 ALUMINA HEAD
    K041443 OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
    K042842 NOVATION 12/14 PRESS-FIT FEMORAL STEM
    K041170 SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
    K042249 CLS SPOTORNO STEM
    K040734 MODIFICATION TO RESTORATION MODULAR SYSTEM
    K040803 MS-30 FEMORAL STEM STANDARD AND LATERAL
    K040644 MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
    K033944 STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
    K033664 MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
    K032348 CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
    K032380 WAGNER CONE PROSTHESIS
    K031803 DEPUY CERAMIC FEMORAL HEADS
    K030724 ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
    K031217 GMRS PRESS FIT STEMS WITH PUREFIX HA
    K030151 CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
    K030373 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
    K023901 ALUMINA V40 FEMORAL HEADS
    K022985 ASCENDENT ACETABULAR SYSTEM
    K022403 GMRS PRESS FIT STEMS WITH PUREFIX HA
    K022549 RESTORATION MODULAR SYSTEM
    K022555 ACCOLADE C FEMORAL STEMS
    K022120 MPF ACETABULAR CUP GENERATION 2
    K021673 TOTAL HIP FEMORAL HEAD - 12/14 TAPER
    K020713 MS-30 LATERAL FEMORAL STEM
    K013106 2 PIECE MODULAR HIP STEM
    K011533 DEPUY FEMORAL HEADS
    K013989 ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
    K013935 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
    K012918 APEX MODULAR ALUMINA FEMORAL HEAD
    K012091 PRO-FEMUR
    K011836 MPF ACETABULAR CUP
    K010839 CLS VARUS STEM/CLS 135 STEM
    K003274 LPC-PLUS ACETABULAR CUP
    K010560 PORTRAIT FEMORAL COMPONENT
    K003923 APEX MODULAR ZIRCONIA FEMORAL HEAD
    K003316 OTI CERAMIC FEMORAL HEAD SYSTEM
    K003379 V-40/C-TAPER ADAPTER SLEEVE
    K003391 OSTEONICS ALUMINA C-TAPER HEAD
    K003413 ALUMINA V40 HEAD
    K002320 ACCOLADE C FEMORAL COMPONENT
    K002441 FENNING HIP STEM
    K001449 TRIDENT ACETABULAR SHELLS: PS
    K993874 BOFOR REVISION COUP
    K000432 RESPONSE 2000 CEMENTED HIP STEM
    K000392 RESPONSE 2000 HIP STEM
    K992359 MRS-TITAN
    K994184 PLR SPLINED REVISION STEM
    K993889 EXETER CERAMIC FEMORAL HEADS
    K991162 BIOLOX ALUMINA CERAMIC FEMORAL HEAD
    K992403 MRP-TITAN
    K993043 MS-30 FEMORAL STEM
    K992235 ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
    K992144 BIOPRO RIMMED ACETABULAR COMPOMENT
    K990261 PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
    K991708 ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
    K991952 OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
    K990183 IMPLEX ALUMINA FEMORAL HEAD
    K991226 FOUNDATION POROUS HIP STEM
    K983404 TYPE 3 FEMORAL COMPONENTS
    K981847 BIOLOX ALUMINA CERAMIC FEMORAL HEAD
    K981302 SMC 28MM CERAMIC FEMORAL HEADS
    K981201 OSTEOLOCK ACETABULAR CUP
    K980774 OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
    K980473 PRESS-FIT STEM
    K980239 PARTNERSHIP CALCAR FEMORAL COMPONENTS
    K980081 S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
    K973837 CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
    K973681 NATURAL-HIP COCR OFFSET STEM
    K972228 MERIDIAN TITANIUM FEMORAL STEMS
    K973261 WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
    K973307 S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
    K973087 MOST HEX INTRAMEDULLARY (I/M) STEM
    K972893 PARTNERSHIP REVISION FEMORAL STEMS
    K972690 ZIRCONIA CERAMIC FEMORAL HEAD
    K972637 PRECEDENT REVISION HIP SYSTEM
    K972361 V40 ZIRCONIA FEMORAL HEADS
    K970675 HEADLOC CERAMIC HEAD
    K964431 ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
    K971752 ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
    K971721 WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
    K971497 OSTEONICS ANTEVERTED NECK HIP STEM
    K971414 ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS
    K971435 HEADLOC CERAMIC FEMORAL HEADS
    K971426 HEADLOC CERAMIC HEAD
    K971409 OSTEONICS ALUMINA C-TAPER HEAD
    K965002 ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
    K970846 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
    K970490 PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
    K970200 RELIANCE PF FEMORAL STEMS
    K970166 NATURAL-HIP SYSTEM COCR REVISION STEM
    K970346 PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
    K964395 PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
    K964357 NATURAL-HIP SYSTEM COCR STEM
    K964704 DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
    K964249 BRIDGE LONG STEM FEMORAL COMPONENT
    K964150 WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD
    K953111 CORAIL
    K955877 ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
    K962248 P.F.C. CERAMIC HIP HEAD
    K962101 ZWEYMUELLER SL FEMORAL HIP STEM
    K961921 APR OVERSIZED HIP STEM
    K960588 WAGNER REVISION STEM
    K961727 NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
    K961589 APR FULLY TEXTURED HIP STEM
    K953690 CLS STEM (MODIFICATION)
    K955117 IMPLEX CERAMIC HEAD
    K955386 CONSENSUS ZIRCONIA FEMORAL HEAD
    K955350 BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
    K953925 FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
    K954768 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K953689 WAGNER REVISION STEM (MODIFICATION)
    K953688 CLS ACETABULAR COMPONENT (MODIFICATION)
    K953792 CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5
    K944689 ZIRCONIA CERAMIC FEMORAL HEAD
    K953045 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K952686 BUCHALTER FAUSER FEMORAL COMPONENTS
    K953169 STELKAST ALL POLYETHYLENE ACETABULAR CUP
    K952418 V40 ZIRCONIA FEMORAL HEADS
    K952088 ZIRCONIA ARTICUL/EZE FEMORAL BALLS
    K946026 HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS
    K943774 OSTEONICS RESTORATION MONOLITHIC HIP STEM
    K945516 NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
    K945096 CDH HIP STEM
    K945095 APC FEMORAL COMPONENT
    K945094 HNR-PC HIP
    K945093 P.C.A. E-SERIES HIP- CEMENTLESS USE
    K945092 P.C.A.PRIMARY HIP- CEMENTLESS USE
    K945090 HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
    K945089 SENTRY TOTAL HIP
    K945091 HOWMEDICA ALUMINA FEMORAL HEAD
    K944601 ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
    K935913 HOWMEDICA SENTRY S TOTAL HIP SYSTEM
    K944209 APR II NON POROUS HIP STEM
    K935921 ZIRCONIA CERAMIC FEMORAL HEAD
    K936256 MODULAR CERAMIC FEMORAL HEAD
    K943586 ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
    K933942 SOLUTION BOWED FEMORAL HIP PROTSTHESIS
    K935452 P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
    K942330 APR II FEMORAL COMPONENT (VARIOUS)
    K933275 P.F.C. CERAMIC HIP HEAD
    K933108 TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS
    K935193 CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEM
    K941942 SOLUTION HIP
    K941847 5/8 POROCOAT AML HIP POROCOAT POROUS COATING
    K934457 STABILITY HIP STEM WITH POROCOAT
    K935185 MORPHOMETRIC TOTAL HIP PROSTHESIS
    K932935 TITAN DYSPLASIC TOTAL HIP PROSTHESIS
    K931617 EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
    K932222 SLT FEMORAL HEAD
    K934694 KIRSCHNER ZIRCONIA FEMORAL HEAD
    K933499 CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM
    K933567 EUROFORM TOTAL HIP PROSTHESIS
    K933203 APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
    K931571 LINK CERAMIC HEADS 12/14 X 32MM
    K922247 KINAMED REALITY TOTAL HIP SYSTEM
    K931929 TECHMEDICA CONTINUUM HIP SYSTEM
    K931572 LINK CERAMIC HEADS 14/16 X 32MM
    K932519 OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
    K926395 ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
    K925345 ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
    K930788 ZIRCONIA CERAMIC FEMORAL HEAD
    K921225 INTEGRAL TOTAL HIP SYSTEM
    K921224 BIMETRIC TOTAL HIP SYSTEM
    K921181 MALLORY-HEAD TOTAL HIP SYSTEM
    K931189 P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
    K930963 SL-PLUS & SLR-PLUS STEMS W/BIOLOX CERAMIC HEADS
    K925682 BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED
    K930712 P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR
    K923808 MULLER STRAIGHT STEM FEMORAL PROSTHESIS
    K915222 WALKER HIP PROSTHESIS
    K923734 TOTAL HIP PROTHESIS FEMORAL COMPONENT
    K920968 INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD
    K925695 OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
    K925512 CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION
    K923583 ORTHOMET PERFECTA TOTAL HIP SYSTEM
    K921836 PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD
    K915641 ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
    K920290 KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL
    K920219 KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL
    K921111 S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD
    K915396 OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
    K920145 BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM
    K920593 CERAMIC FEMORAL HEAD
    K920756 FELDMUHLE CERAMIC HEAD
    K920577 HOWEDICA ZIRCONIA FEMORAL HEAD
    K915310 KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
    K915309 KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
    K915184 HOWMEDICA ALUMINA FEMORAL HEAD
    K913420 ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
    K914676 ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
    K914574 EXACTECH CERAMIC FEMORAL HEAD COMPONENT
    K912985 LIMA 28MM CERAMIC HEAD, MODIFICATION
    K914237 KINAMED CTN STEM
    K912641 BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
    K913633 TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS
    K912295 KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
    K905687 ZIRCONIA CERAMIC MODULAR HEADS
    K910547 FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)
    K910548 FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)
    K905739 ZIMMER CERAMIC FEMORAL HEADS
    K905260 TOTAL HIP FEMORAL COMPONENT
    K904028 DCW MODULAR PROXIMAL FEMORAL SYSTEM
    K903976 CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
    K902712 OSTEONICS PS HEAD AND NECK HIP STEM SERIES
    K902074 KINAMED CEMENTED CTH STEM
    K902073 KINAMED CEMENTED ATH-LONG STEM
    K896850 LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE
    K900628 MODULAR HIP SYSTEM
    K894904 KINAMED CERAMIC ATH TOTAL HIP - 28MM BALL
    K896669 WEBER PERMALOCK
    K895399 KIM MODULAR FEMORAL HIP PROSTHESIS
    K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
    K892644 BIOLOX CERAMIC BALL
    K894694 OMNIFIT CERAMIC MORSE TAPER HEAD
    K893685 CERAMIC FEMORAL HEAD
    K890472 ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
    K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
    K885102 OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
    K891083 CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER
    K891082 CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
    K884952 VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
    K890060 CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
    K861400 THREADED TITANIUM METAL BACKED ACETABULAR CUP
    K860275 TI-FIT ACETABULAR COMPONENT
    K844906 THREADED TITANIUM METAL BACKED ACETABULAR CUP

    FEI Numbers

    This FDA classification entry is associated with 284 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 284 registration numbers. Click on an entry to view related FDA registrations.