BEUDAMED
    Product Code: LWJ FDA class 2 21 CFR 888.3360

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

    Orthopedic

    The Uncemented Semi-Constrained Metal/Polymer Hip Prosthesis (product code LWJ) is an orthopedic implant used to replace a damaged or diseased hip joint with a metal and polymer construct that achieves fixation through biological bone ingrowth rather than bone cement. Regulated under 21 CFR 888.3360 and classified as a Class 2 device, it requires a 510(k) premarket notification and is reviewed under the Orthopedic panel. The device is flagged as an implant due to its surgical placement within the body. It is not life-sustaining.

    View on FDA
    510(k)s
    81
    FEI Numbers
    163
    Registration Numbers
    163
    Unique Applicants
    37
    Years Active
    29

    Basic Information

    Product Code
    LWJ
    Device Class
    FDA class 2
    Regulation Number
    888.3360
    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 81 510(k) clearances via K numbers.

    K Number Device Name
    K120595 UNISYN PLUS HIP STEM
    K103518 TRINITY ACETABULAR SYSTEM
    K090764 NOVATION CFS PRESS-FIT AND CEMENTED STEMS
    K082146 METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
    K070061 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT
    K062978 U2 HIP STEM, TI PLASMA SPRAY
    K062383 UNISYN HA PLASMA MODULAR HIP
    K061699 EXCIA
    K051826 BETACONE HIP PROSTHESIS SYSTEM
    K050262 U2 ACETABULAR COMPONENT
    K042344 EXCIA TOTAL HIP SYSTEM
    K040685 Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
    K033313 QUATRO M FEMORAL COMPONENT
    K032709 MODULAR PLUS HIP STEM
    K032110 PROCLASS PRESS FIT HIP STEM
    K030971 MODIFICATION TO MODULAR PLUS REVISION STEM
    K023692 GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
    K030122 DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
    K024134 UNI HIP STEM
    K022966 PROXILOCK HIP PROSTHESIS; SIZE 12/36
    K003649 TRITON HIP SYSTEM
    K010243 TRI-FIT FEMORAL STEM
    K003016 PRO-FEMUR R
    K994146 EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
    K002941 ACETABULAR PLATES
    K002575 INTER-OP DURASUL ACETABULAR INSERTS (4MM)
    K002796 MODIFICATION TO PROVIDENT HIP SYSTEM
    K002141 ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
    K001471 THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
    K001745 MODIFICATION TO PROVIDENT HIP SYSTEM
    K001942 SL-PLUS AND SLR-PLUS STEMS
    K994126 MODULAR-PLUS REVISION STEM
    K993601 HOWMEDICA OSTEONICS FEMORAL HEADS
    K982936 OSTEONICS EXTENDED FEMORAL BEARING HEAD
    K971900 LATERAL FLARE INTERNAL COLLAR (LFIC)
    K973077 PLUS-FIT ACETABULAR CUP
    K972931 PLUS EPF ACETABULAR CUP
    K964178 PRESS-FIT HIP STEM
    K955553 PERFECTA REVISION HIP SYSTEM
    K962268 CHROME COBALT BALL HEAD
    K962034 SC, CEMENTLESS HIP SYSTEM
    K961378 DELTA HIP PROSTHESIS
    K963155 INTERMOORE FRACTURE HIP STEM (MODIFY)
    K960633 PRESS-FIT FLARED SHELL
    K960908 SRRS PRESSED FIT FEMORAL REVISION COMPONENT
    K954854 INTERMOORE FRACTURE HIP STEM
    K952776 LFIC OR FETTO HIP
    K953268 DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
    K952297 FOUNDATION TEXTURED STEM
    K950541 HOWMEDICA V40 22MM FEMORAL HEAD
    K931423 PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
    K934909 COBALT CHROME GEMINI
    K933359 OSTEONICS 22MM, +10 NECK BEARING HEADS
    K921382 FUTURA TEXTURE-TRAKKED TOTAL HIP STEM
    K923911 INTRINSIC STEM
    K910664 MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.
    K913708 VENUS HIP
    K914343 TI-FIT FEMORAL COMPONENT
    K903563 HOWMEDICA HNR SYSTEM
    K910010 Q SYSTEM 28 HIP STEM
    K905254 THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
    K905186 GERI TOTAL HIP SYSTEM
    K900435 ACSYS SHEARER ACETABULAR CUP PROSTHESIS
    K900262 ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
    K901687 F-24 FEMORAL HIP PROSTHESIS
    K901594 H.N. TOTAL HIP PROSTHESIS
    K895702 KDR ACETABULAR COMPONENT
    K890331 FREEMAN TOTAL HIP SYSTEM RIDGED STEM
    K894051 PREMIER-TOTAL HIP
    K893785 ARC-2F ACETABULAR CUP
    K893584 GRIPPER II ACETABULAR CUP
    K891539 CTI II STRAIGHT STEM
    K891262 KDG ACETABULAR COMPONENT
    K883794 RESUBMITTED CLW ACETABULAR CUP W/SULMESH
    K883661 MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
    K883921 OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
    K881983 HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
    K881288 CORIN MODULAR MOORE STEM
    K870088 S-ROM SUPERCUP ACETABULAR CUP
    K873797 TI-FIT TOTAL HIP SYSTEM
    K833970 MICRO-STRUCTURED HS2P HIP STEMS

    FEI Numbers

    This FDA classification entry is associated with 163 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 163 registration numbers. Click on an entry to view related FDA registrations.