BEUDAMED
    Product Code: LPH FDA class 2 21 CFR 888.3358

    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    Orthopedic

    This device is a semi-constrained, porous uncemented hip prosthesis with metal-on-polymer bearing surfaces, used in total hip arthroplasty to replace a diseased or damaged hip joint and achieve fixation through bone ingrowth into the porous coating. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LPH, regulated under 21 CFR 888.3358, within the Orthopedic medical specialty. This device carries the implant flag, as it is permanently placed within the patient's body.

    View on FDA
    510(k)s
    552
    FEI Numbers
    271
    Registration Numbers
    271
    Unique Applicants
    157
    Years Active
    41

    Basic Information

    Product Code
    LPH
    Device Class
    FDA class 2
    Regulation Number
    888.3358
    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 552 510(k) clearances via K numbers.

    K Number Device Name
    K243456 ONVOY™ Acetabular System
    K242744 Trinity EVO Acetabular Shell
    K242232 Mpact 3D Metal Augments II
    K242045 Initia T3 Acetabular Hemispherical Shell System
    K243784 Stryker Orthopaedics Hip Devices Labeling Update
    K243977 EMPHASYS Acetabular System
    K241059 Pantheon Proximal Femur Reconstruction (PFR) System
    K241636 MobileLink Acetabular Cup System - Line Extension (Multiple)
    K242833 Legend® Acetabular Shell
    K242375 OR3O Dual Mobility System
    K242084 EMPHASYS Acetabular Shell with RapiTite HA
    K240046 Ethylene Oxide Sterilization Supplier Change for MPO Hips
    K231522 EMPHASYS™ Dual Mobility System
    K233498 Stryker Orthopaedics Hip Systems Labeling Update
    K232667 OR3O Dual Mobility Liners
    K232556 DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
    K230011 Mpact Extension
    K222436 Latitud™ Hip Replacement System
    K222066 LINK MobileLink Acetabular Cup System
    K223223 BENCOX Mirabo Z Cup Cortinium
    K223779 EMPOWR™ blade stem
    K223348 My3D® Personalized Pelvic Reconstruction
    K211047 CoCr Head
    K221675 United U2 femoral head, 22mm delta ceramic head
    K213842 ONVOY Acetabular System
    K220336 Mg-PSZ Ceramic Femoral Head
    K221636 EMPHASYS Acetabular System
    K220959 OR3O Dual Mobility System
    K212815 My3D® Personalized Pelvic Reconstruction
    K211176 Smith & Nephew Hip Systems
    K201348 DePuy 3D Additive TriFlange Acetabular Cup
    K210614 BENCOX Mirabo Z Cup Cortinium
    K220468 BENCOX Mirabo Cup System
    K212761 Biocore9 Acetabular Cup System
    K220376 Acetabular Dome Hole Plug
    K212187 Restoration® Modular Hip System
    K211330 R3 Large Head Liners
    K202568 Mpact® 3D Metal Implants - DMLS Technology
    K200011 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
    K211866 Bencox THR System
    K201733 Provident II Hip Stems
    K200607 LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
    K200391 MPACT Extension
    K210893 Restoration Anatomic Shell
    K203557 EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
    K202472 ACTIS Duofix Hip Prosthesis
    K202484 Cordera Hip System
    K200854 DePuy PINNACLE Dual Mobility Liner
    K191708 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
    K200656 Delta Multihole TT Pro Acetabular System
    K193233 Restoration® Modular Hip System
    K191826 KeYi Total Hip System
    K192450 Precision Casting Solutions Total Hip System
    K190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
    K190660 G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
    K192919 Pinnacle Duofix HA Acetabular Cup Prosthesis
    K192198 Conformis Hip System
    K183457 Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
    K191622 Delta Multihole TT Pro Acetabular System
    K191002 OR3O Dual Mobility System
    K190847 REDAPT Blade Augments
    K191358 Trident II Acetabular System
    K192071 iNSitu Total Hip System
    K190904 Conformis BeneFIT Hip System
    K191936 iNSitu Total Hip System
    K183129 Medtronic Total Hip Arthroplasty System
    K190123 MicroPort CoCr Femoral Heads
    K190057 DJO Acetabular System
    K182678 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
    K182221 Bencox Mirabo Cup Multi Hole
    K183582 MPACT Extension
    K182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
    K182502 Alteon Acetabular Cup System
    K190276 Provident II Hip Stem
    K182099 Delta TT Pro
    K182109 REDAPT Modular Acetabular Shell
    K181366 REDAPT Porous Acetabular Shell
    K172857 Latitud Hip Replacement System
    K180798 Prime Acetabular Cup System
    K172551 Trinity PLUS Acetabular Shell
    K173951 Legend Acetabular Liners
    K171966 Mpact® 3D Metal™ Implants and Augments 3D Metal™
    K172456 Bone Screws 6.5mm
    K171934 Birmingham Hip (BH) Dual Mobility Insert
    K171073 Smith & Nephew, Inc. REDAPT Augments
    K172251 UTS Stem
    K172806 Bencox Mirabo Cup System
    K172684 Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
    K171768 Trident® II Acetabular System
    K172501 iNSitu Total Hip System
    K171962 Klassic HD® Hip System
    K162957 U2 Femoral Head
    K170444 PROCOTYL® PRIME Acetabular Cup System
    K162719 iTotal® Hip Replacement System
    K163193 UTF Stem, reduced, #0, #00
    K162127 Bencox M Stem Lateralized & Bencox Mirabo Cup System
    K161073 Klassic HD Hip System
    K161569 Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
    K161184 iNSitu Total Hip System
    K151424 The Progressive Orthopaedic Total Hip System
    K161190 G7 Dual Mobility System, Active Articulation System
    K153345 Stryker Orthopaedics Hip Systems Labeling Update
    K161080 Escalade Legend Acetabular Shell
    K152084 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
    K160266 ICONACY(TM) I-Hip(TM)
    K150790 REDAPT Porous Acetabular Shell and Cemented Liner
    K151603 Arcos One-piece Femoral Revision System
    K151440 Klassic HD Hip System
    K141960 Exactech® Novation® Crown Cup®
    K151448 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
    K151316 U2 Hip Stem, Ti Porous Coated, Matrix
    K151264 Restoration Anatomic Shell
    K150007 Modified Bencox Hip System
    K150522 G7 Dual Mobility System
    K150503 Echo Bi-Metric Microplasty Line Extension
    K143453 Mpact Double Mobility System
    K143314 Progressive Orthopaedic Total Hip System
    K142119 PROCOTYL L-O ACETABULAR SYSTEM
    K142882 G7 Freedom and Offset Liners, Freedom Head, Size 32
    K143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
    K142606 Trident® Tritanium® PST® Acetabular Shells
    K142201 OMNI Interface Acetabular System
    K140547 EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM
    K142746 G7 Finned Acetabular Shell
    K143009 Echo Bi-Metric Microplasty Hip System
    K140669 G7 OSSEOTI ACETUBLAR SHELLS
    K142462 Restoration Anatomic Shell
    K141676 RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
    K141001 ALPINE HIP STEM; ALPINE HA HIP STEM
    K141797 ALTEON 6.5MM BONE SCREWS
    K133370 REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
    K141395 DELTA TT ACETABULAR SYSTEM
    K132697 ENCOMPASS 10/12 HIP STEM
    K141043 CS2 MULTI-HOLE ACETABULAR SHELL
    K132312 RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
    K132572 I-HIP TOTAL HIP SYSTEM
    K133832 KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
    K133386 OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
    K132959 DEPUY PINNACLE ALTRX ACETABULAR LINERS
    K132158 NOVOHIP TOTAL HIP SYSTEM
    K131454 KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
    K132879 MPACT EXTENSION
    K133228 ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
    K131022 OVATION 10/12 HIP STEM
    K132626 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
    K132207 UTF STEM-REDUCED, ADDITIONAL SIZES
    K131279 ICONACY I-HIP SYSTEM
    K130353 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
    K130099 TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
    K131237 PIPELINE TOTAL HIP SYSTEM
    K130149 U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
    K123550 UTF STEM, REDUCED
    K120599 DEPUY M-SPEC 36MM FEMORAL HEADS
    K130063 ARCOS TROCHANTER BUTTON
    K121297 ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
    K112898 DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
    K122512 CS2 HIP SYSTEM
    K122636 REVELATION POROUS COATED HIP STEM, SIZE 8
    K123012 SMITH & NEPHEW SMF HIP STEM
    K121636 ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
    K123019 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
    K122798 INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
    K122504 FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
    K122099 BENCOX II STEM, BENCOX METAL HEAD
    K121684 NOVATION LPI PRIME FEMORAL STEM
    K113296 ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
    K121935 TAPERSET HIP SMALL STEMS
    K120924 BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
    K121034 IOI TOTAL HIP
    K122244 POLARCUP DUAL MOBILITY SYSTEM
    K120030 TAPERLOC COMPLETE SIZE 4MM AND XR 123
    K121308 HIP SYSTEMS
    K121777 U2 ACETABULAR CUP, PLASMA SPRAY
    K121024 LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;
    K121263 TAPER SET HIP SYSTEM RDP STEM
    K112158 MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
    K120241 LINEAR HIP STEM, SIZE 5
    K113242 APEX ARC HIP STEM
    K113609 NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
    K112779 APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
    K110135 POLARCUP DUAL MOBILITY SYSTEM
    K111472 HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
    K110245 UNITED UTF STEM
    K103431 COREN TOTAL HIP SYSTEM
    K111546 U2 HIP SYSTEM
    K110947 APEX K1 HIP STEM
    K103662 CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI
    K101072 TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
    K110542 CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
    K110555 ARCOMXL ACTIVE ARTICULATION
    K103721 MPACT ACETABULAR SYSTEM
    K103384 ESCALADE ACETABULAR CUP SYSTEM
    K102019 RESTORATION ACETABULAR WEDGE AUGMENTS
    K103256 SMITH & NEPHEW SMF HIP STEM
    K101336 E1 AVANTAGE HEAD
    K101229 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
    K100445 KLASSIC HD HIP SYSTEM
    K102399 CONSENSUS TAPERSET HIP SYSTEM
    K103124 SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
    K102975 NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
    K102423 DEPUY PINNACLE ALTRX ACETABULAR LINERS
    K100933 CONSENSUS CS2 PLUS ACETABULAR INSERT
    K101761 EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13
    K101976 INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
    K101575 APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
    K100269 NOVATION CROWN CUP GXL LINERS
    K093561 ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
    K094045 MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM
    K100555 APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
    K092098 PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
    K092443 INTERFACE ACETABULAR CUP LINERS
    K090897 TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
    K091508 ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
    K081566 SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
    K081679 REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05
    K081171 TRITANIUM ACETABULAR SHELL SYSTEM
    K072817 ECHELON TITANIUM HIP SYSTEM
    K080625 SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
    K073150 APEX-LNK POLY ACETABULAR CUP LINERS
    K073068 ACCIN HIP SYSTEM
    K072888 REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
    K072417 SMITH & NEPHEW MIS HIP STEM
    K072963 DEPUY PINNACLE ALTRX ACETABULAR LINERS
    K072154 FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
    K072101 RIGI-FIX HIP STEM SYSTEM
    K071160 REFLECTION, TANDEM UNIPOLAR
    K062489 APEX HCLA ACETABULAR CUP LINERS
    K071784 DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
    K070050 VITALITY HIP SYSTEM MODEL#420
    K070278 POLARCUP DUAL MOBILITY SYSTEM
    K070369 REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
    K063822 MODIFICATION TO HIPSTAR FEMORAL STEM
    K062775 EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
    K061461 MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
    K063257 FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT
    K062419 TRIDENT LARGE DIAMETER ACETABULAR INSERTS
    K062148 DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
    K060072 MONOBLOCK PRESS-FIT HIP STEM
    K061434 TRIDENT LARGE DIAMETER HIP SYSTEM
    K061226 TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
    K061786 VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
    K053417 M-COR HIP REPLACEMENT SYSTEM
    K061168 PCA 36MM FEMORAL HEADS
    K061124 ORTHOPEDIC SOURCE PRESS-FIT HIP
    K061833 DEPUY AML HIP PROSTHESIS
    K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER
    K060630 REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
    K061067 TRABECULAR METAL ACETABULAR AUGMENTS
    K060581 DEPUY SOLUTION SYSTEM HIP PROSTHESIS
    K060040 ZIMMER M/L TAPER HIP PROSTHESIS
    K060635 CONSENSUS ACETABULAR SHELL SYSTEM
    K052996 POROUS TITANIUM ACETABULAR SHELLS
    K052089 XR-SERIES BI-METRIC FEMORAL COMPONENTS
    K053293 ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
    K052321 VERSYS EPOCH FULLCOAT HIP PROSTHESIS
    K060031 DEPUY MODULAR M HEADS
    K053557 ESKA-LIBUR HIP STEM
    K052026 LINEAGE A-CLASS POLY LINER
    K052255 ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
    K050327 E-POLY (VITAMIN E) ACETABULAR LINERS
    K051556 ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
    K051491 TRABECULAR METAL PRIMARY HIP PROSTHESIS
    K050937 TRABECULAR METAL ACETABULAR REVISION SHELLS
    K042989 RX90 LOW PROFILE ACETABULAR SYSTEM
    K042565 ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
    K042051 ARCOMXL POLYETHYLENE LINERS
    K043123 APEX MODULAR HA HIP STEM
    K033716 TRIDENT ACETABULAR SYSTEM
    K042774 MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
    K043537 TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
    K042871 TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3
    K041950 APEX K2 HIP SYSTEM
    K041850 MEDALLION MODULAR HIP SYSTEM
    K042252 NEXFLEX TOTAL HIP SYSTEM
    K031402 PERFECTA FEMORAL STEM
    K042029 X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
    K042776 VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
    K042337 ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
    K041906 EXACTECH 12/14 TOTAL HIP SYSTEM
    K040191 BICONTACT HIP STEM AND FEMORAL HEAD
    K033580 NEXFLEX TOTAL HIP SYSTEM
    K041109 ZIMMER ANATOMIC II HIP PROSTHESIS
    K040544 DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
    K040412 TRIDENT T ACETABULAR SHELLS
    K040383 TRIFLANGE II ACETABULAR CUP SYSTEM
    K033273 DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
    K033893 SPECTRUM MODULAR SYSTEM
    K033338 PINNACLE REVISION SYSTEM
    K032729 Z-SERIES MODULAR TOTAL HIP SYSTEM
    K032964 EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS
    K033034 VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
    K032385 GLOBAL PRESS-FIT STEM
    K032726 ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
    K032581 GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
    K030055 MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
    K031693 MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
    K031572 ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
    K030861 HA PMI FLANGED ACETABULAR COMPONENT
    K031495 PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
    K031110 APEX MODULAR ACETABULAR CUP
    K030733 MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
    K030979 MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
    K030501 X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
    K021878 ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
    K022520 U2 ACETABULAR CUP
    K030236 ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
    K030079 VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
    K030048 HA PMI FEMORAL HIP STEM
    K023409 HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
    K023357 ARCPM 1050 RESIN-HIPS
    K023375 MODIFICATION TO ESOP CO-CR FEMORAL HEADS
    K022382 RHS ACETABULAR COMPONENT
    K022902 SMITH & NEPHEW HIP SYSTEM
    K021891 ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
    K022556 REFLECTION MODIFIED ACETABULAR SHELLS
    K022711 MODIFICATION TO AVALON CUP SYSTEM
    K022463 HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
    K014070 EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
    K021466 CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
    K021970 THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
    K021911 TRIDENT CROSSFIRE POLYUETHYLENE LINERS
    K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
    K021109 ESOP CO-CR FEMORAL HEADS
    K020153 CONSENSUS ACETABLAR SHELL, TI COATED
    K020145 ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
    K020580 X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
    K012787 VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE
    K020497 TRIDENT ELEVATED RIM LINER
    K020170 KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
    K013490 CEMENTED CALCAR HIP SYSTEM
    K013475 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
    K013658 MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
    K012739 CONVERGE ACETABULAR SYSTEM
    K012364 AML HIP PROSTHESIS
    K012507 THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
    K011489 SUMMIT DUOFIX HIP PROSTHESIS
    K011081 ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
    K010170 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
    K010171 DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
    K010367 MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
    K003875 TI-REPLICA HIP STEM
    K004032 PERFECTA AND EXTEND
    K010282 LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
    K010120 MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
    K003800 AML HIP PROSTHESIS
    K010241 PROTRACT PRESS FIT HIP STEM-HA COATED
    K003478 TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
    K003237 U2 HIP STEM, TI POROUS COATED
    K003199 TRIAD II MODULAR TOTAL HIP SYSTEM
    K003447 PROTRACT PRESS FIT HIP STEM
    K002747 REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
    K002960 TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
    K994078 U1 HIP SYSTEM
    K003429 MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
    K003181 IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
    K002149 LINEAGE ACETABULAR SYSTEM
    K001991 TITAN POROCOAT HIP PROSTHESIS
    K000788 APEX MODULAR HIP STEM
    K001982 TRI-LOCK HIP STEM
    K001778 POROCOAT PRODIGY HIP PROSTHESIS
    K001320 SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
    K001277 TRIFLANGE ACETABULAR CUP SYSTEM
    K001039 THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
    K001660 MALLORY HEAD MODULAR CALCAR
    K001534 PINNACLE ACETABULAR SYSTEM
    K000760 REACH FEMORAL COMPONENT
    K000521 KEYSTONE HIP
    K990830 MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
    K000321 HEMISPHERE MODULAR CUP SYSTEM
    K993027 ESKA MODULAR HIP SYSTEM
    K992154 BICON-PLUS ACETABULAR COMPONENTS
    K000306 PINNACLE ACETABULAR SYSTEM
    K000538 MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
    K994286 ZMR HIP SYSTEM-POROUS REVISION
    K993259 INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
    K000335 MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
    K000334 IMPACT MODULAR TOTAL HIP SYSTEM
    K000207 POROCOAT PRODIGY HIP PROSTHESIS
    K994415 MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
    K994070 REVELATION POROUS HIP STEM
    K993736 EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
    K994038 MODULAR REACH HIP
    K990849 DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
    K993352 CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
    K993082 EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
    K992667 ZMR HIP SYSTEM-REVISION TAPER
    K991026 REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
    K992109 ENCORE FULLY COATED HIP
    K991485 SYNERGY POROUS SIZE 8 HIP STEM
    K990135 TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
    K991807 TITANIUM LOW PROFILE SCREWS
    K983837 HEDROCEL ACETABULAR CAGE SYSTEM
    K991325 MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
    K991123 PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
    K990523 B2C, ESPACE REVISION CUP SYSTEM
    K984492 TIGRAN HIP PROSTHESIS
    K990003 J-SERIES OMEGA TOTAL HIP SYSTEM
    K983834 ECHELON HIP STEM
    K984296 LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
    K984408 130 MODIFIED INTEGRAL FEMORAL COMPONENT
    K983509 INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
    K984459 DEPUY PROFILE FEMORAL HIP WITH POROCOAT
    K983502 OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
    K983491 DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
    K983035 CUSTOM FLANGED ACETABULAR COMPONENT
    K980711 HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
    K983014 SUMMIT ACETABULAR SYSTEM
    K982248 HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
    K982367 REACH HIP COMPONENT
    K981211 APR -T REVISION HIP STEM
    K980981 OMEGA HA COATED TOTAL HIP SYSTEM
    K980020 ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
    K974740 DEPUY TRI-LOCK HIP STEM
    K974506 LSF HA COATED TRIAD TOTAL HIP SYSTEM
    K971206 MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING
    K974331 UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM
    K974095 FOUNDATION POROUS COATED FLARED RIM SHELL
    K974093 FOUNDATION POROUS COATED HEMISPHERICAL SHELL
    K973119 FOUNDATION POROUS ACETABULAR SYSTEM
    K974294 ENCORE LINEAR POROUS COATED HIP
    K973714 VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
    K973685 REVELATION POROUS HIP STEM
    K973675 NATURAL-HIP POROUS STEM WITH OFFSET
    K971824 REACH FEMORAL HIP COMPONENT
    K973302 FOUNDATION POROUS HIP STEM
    K973163 ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
    K972596 DEPUY DURALOC ACETABULAR CUP SYSTEM
    K973124 APR POROUS HA HIP SYSTEM
    K971018 SMC ACETABULAR COMPONENT
    K973530 INFINTY DISTAL FEMORAL COMPONENT
    K972393 INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
    K970241 DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
    K964616 QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
    K971854 OSTEOLOCK ACETABULAR SHELL SYSTEM
    K971718 MICRO-SEAL ACETABULAR SYSTEM
    K971429 INTERSEAL ACETABULAR SCREW HOLE PLUG
    K970300 NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
    K964650 TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
    K964509 IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
    K971020 LSF TRIAD TOTAL HIP SYSTEM
    K970706 INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
    K970705 INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
    K970501 PEGGED ACETABULAR COMPONENT
    K965164 HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
    K964882 IMPLEX REPLACEMENT ACETABULAR CUP INSERT
    K964924 OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
    K964769 VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
    K963101 B-P HEMISPHERICAL ACETABULAR COMPONENT
    K963100 TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
    K963998 METAL BACKED ACETABULAR COMPONENT
    K963946 OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
    K963509 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
    K964227 METAL ACETABULAR COMPONENT
    K943230 MAYO HIP PROSTHESIS
    K963309 APEX HOLE ELIMINATOR PS
    K963266 NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
    K962769 HORIZON HIP SYSTEM
    K962923 DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
    K961526 PRESS-FIT POROUS SHELL
    K961186 DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
    K961625 QUATROLOC FEMORAL COMPONENT & HEAD
    K961939 S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
    K955563 FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
    K960303 FENNING FEMORAL COMPONENT
    K960660 HEMISPHERE ACETABULAR CUP
    K960180 22 MM COCR HEAD & POLYETHLENE LINER
    K960172 DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
    K955739 MODULAR ACETABULAR SHELL II
    K955871 HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
    K955511 ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
    K955170 NEXFLEX FEMORAL STEM, STANDARD DESIGN
    K953703 DEPUY VISION SOLUTION HIP PROSTHESIS
    K953694 DEPUY VISION AML HIP PROTHESIS
    K955033 RIM FLARE ACETABULAR COMPONENT
    K955271 MICRO-SEAL ACETABULAR SYSTEM
    K954935 S-ROM FEMORAL HIP STEM - SIZE 14 X 8
    K953337 BETA HIP PROSTHESIS
    K954811 DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT
    K954698 TRILOGY ACETABULAR COMPONENT 7MM OFFSET
    K954417 A-B ACETABULAR COMPONENT
    K954466 PROFORM POROUS BEADED FEMORAL STEM
    K954288 EXTEND HIP SYSTEM
    K954213 ATH FULL PROFILE ACETABULAR CUP SYSTEM
    K953664 VITALOCK SPIKED ACETABULAR SHELL
    K953490 TRILOGY ACETABULAR SHELL & LINERS 36MM
    K952740 DEPUY DURALOC 400 ACETABULAR CUP
    K936292 PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
    K934060 HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE
    K933882 OSTEONICS PS HEMI-HIP STEM SERIES
    K951741 REPLICA TOTAL HIP SYSTEM
    K952397 VITALOCK SOLID BACKED ACETABULAR SHELL
    K941612 F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)
    K951356 VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED
    K951115 HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS
    K951114 SYSTEM 12 P1 26MM ACETABULAR INSERT
    K940715 OSTEONICS OMNIFIT AD HIP STEM SERIES
    K936310 ORTHOMET HMC FEMORAL STEM COMPONENT
    K944592 PRECISION OSTEOLOCK FEMORAL COMPONENT
    K951674 DEPUY DURALOC 100C ACETABULAR CUP
    K951095 10.5MM REPLICA HIP STEM
    K951301 DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
    K950827 PROFORM POROUS ACETABULAR ASSEMBLY
    K951000 ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
    K934515 BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
    K921525 HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
    K934334 APOGEE HIP STEM WITH POROCOAT
    K931333 ORTHOMET ACETABULAR CUP SYSTEM
    K943054 OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
    K942115 INFINITY REVISION HIP STEM
    K941141 PRECISION OSTELOCK SP FEMORAL COMPONENT
    K935875 OSTEONICS SCREWLESS ACETABULAR COMPONENTS
    K935484 PROVIDENT HIP SYSTEM
    K934412 COATED ZT PROXIMAL SLEEVE
    K933102 HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
    K932924 IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
    K932755 REFLECTION ACETABULAR COMPONENT
    K932923 IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS
    K934765 TRILOGY ACETABULAR SYSTEM
    K931642 RMHS MONOLITHIC FEMORAL COMPONENT
    K933787 POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
    K931641 POROCOAT POROUS COATING
    K926156 REPLICA(TM) TOTAL HIP SYSTEM
    K935731 ACETABULAR SHELL
    K925172 PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)
    K922071 ZIMMER ANATOMIC HIP SYSTEM
    K921557 BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
    K921308 HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
    K923452 PMI HIP FEMORAL
    K921301 TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
    K921277 RANAWAT/BURSTEIN TOTAL HIP SYSTEM
    K921274 METALLIC TOATAL HIP SYSTEM
    K920955 APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE
    K922500 PSL TOTAL HIP REPLACEMENT SYSTEM
    K921114 EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
    K921113 EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
    K922159 INFINITY POROUS-COATED TROCHANTERIC MODULE
    K926107 ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
    K926201 OSTEONICS MICROSUTERED FEMORAL COMPONENTES
    K921400 HIP JOINT PROTHESIS
    K924492 POLY-DIAL INSERTS
    K921639 BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
    K920831 PCA TOTAL HIP SYSTEM (CEMENTLESS USE)
    K896637 ACCESS(TM), SOFTWARE RELEASE 4.11P
    K862702 TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
    K862326 POROUS COATED HIP FEMORAL PROSTHESIS
    K860442 PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259
    K860635 OPTI-FIX TOTAL HIP SYSTEM
    K852198 AML PROXIMAL POROCOAT FEMORAL HIP
    K851421 S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP
    K833681 POROCOAT HPS II HIP PROSTHESIS
    K833439 POROCOAT NEB TOTAL HIP SYSTEM
    K833464 POROCOAT SCHATZKER ACETABULUM

    FEI Numbers

    This FDA classification entry is associated with 271 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 271 registration numbers. Click on an entry to view related FDA registrations.