BEUDAMED
    Product Code: OQG FDA class 2 21 CFR 888.3358

    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

    Orthopedic

    The Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented (product code OQG) is an orthopedic implant used for total hip arthroplasty. It is indicated for conditions including non-inflammatory degenerative joint disease such as osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, treatment of proximal femur fractures unmanageable by other techniques, and revision procedures where prior treatments have failed. As an FDA Class 2 device under regulation 888.3358, it requires 510(k) premarket clearance and falls within the Orthopedic specialty. The device is flagged as an implant and is available for both cemented and uncemented use. It is not life-sustaining.

    View on FDA
    510(k)s
    20
    FEI Numbers
    120
    Registration Numbers
    120
    Unique Applicants
    14
    Years Active
    10

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    Basic Information

    Product Code
    OQG
    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

    Definition

    1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 20 510(k) clearances via K numbers.

    K Number Device Name
    K202705 Prime and DYNASTY® Additive Manufacturing Shells
    K203472 KMTI Hip Replacement System
    K201660 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
    K200328 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
    K172651 FMP Extended Liners
    K171543 Renovis Surgical Hip Replacement System
    K173104 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
    K143647 Renovis Surgical Hip Replacement System
    K140130 X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
    K141972 KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
    K140701 NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
    K130652 VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
    K122783 PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
    K130365 X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
    K122158 PBP TOTAL HIP SYSTEM
    K122773 CROSS-OVER ACETABULAR SHELL & LINER
    K112897 RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
    K120370 VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
    K112802 PIPELINE TOTAL HIP SYSTEM
    K094035 EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM

    FEI Numbers

    This FDA classification entry is associated with 120 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 120 registration numbers. Click on an entry to view related FDA registrations.