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510(k) Data Aggregation

    K Number
    K252623

    Validate with FDA (Live)

    Device Name
    G7® Revision Acetabular System
    Manufacturer
    Zimmer, Inc.
    Date Cleared
    2026-02-04

    (169 days)

    Product Code
    LPH,KWZ,LZO,OQG,OQH,OQI,PBI
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K140669
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The G7® TM Acetabular System is intended for total hip arthroplasty in skeletally mature patients for the following indications:

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

    Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

    Device Description

    The G7® TM Acetabular System consists of a Trabecular Metal® coated acetabular shell, available in multi screw hole patterns, and Rim Fix™ screws.

    The G7® TM Acetabular System is intended for use without bone cement in total hip arthroplasties. This system provides surgeons with multiple acetabular implant options to address a range of patient anatomies.

    The G7® TM acetabular shells are made from Tivanium® (Ti-6Al-4V ELI Alloy) as per ASTM F136-13 with a porous Tantalum pad (Trabecular Metal®) per ASTM F560-22 that is diffusion bonded to the exterior of the shell.

    The subject shells are designed to be compatible with the existing G7® acetabular liners and other accessories and instruments provided in the G7® Acetabular System platform.

    The Rim Fix™ screws are self-tapping screws made from the same material of the shell, Tivanium® (Ti-6Al-4V Alloy) per ASTM F136-13. The subject screws are designed for use in the perimeter of the G7® TM acetabular shell rim to provide additional inferior fixation.

    The subject implants are provided sterile and are for single-use only.

    AI/ML Overview

    N/A

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