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510(k) Data Aggregation

    K Number
    K252443
    Device Name
    SpaceFix Shoulder Spacer
    Manufacturer
    G21 S.R.L
    Date Cleared
    2025-09-15

    (42 days)

    Product Code
    MBB
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K202338,K152267
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SpaceFix Shoulder Spacer is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing a total or hemi shoulder arthroplasty revision due to prosthetic joint infection.

    The device is indicated for use when the infecting organism is sensitive to gentamicin, as the PMMA bone cement includes gentamicin for local antibiotic delivery.

    Following prosthesis explantation and thorough debridement, the device is implanted in the glenoid cavity and humeral canal.

    At the conclusion of the temporary implantation period (not to exceed 180 days), the device must be removed and either replaced with a definitive shoulder prosthesis or alternative surgical intervention (e.g., resection arthroplasty, fusion).

    Device Description

    The SpaceFix Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stainless steel core. The subject device is provided sterile, single use and is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing total or hemi shoulder arthroplasty revision due to prosthetic joint infection.

    AI/ML Overview

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