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510(k) Data Aggregation

    K Number
    K223441
    Device Name
    SpaceFlex Acetabular Cup
    Manufacturer
    G21, S.r.l.
    Date Cleared
    2023-03-23

    (129 days)

    Product Code
    KWY, KWL
    Regulation Number
    888.3390
    Why did this record match?
    Applicant Name (Manufacturer) :

    G21, S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process. The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement) and positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The molded acetabular cup is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The molded temporary Acetabular cup prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.
    Device Description
    The SpaceFlex Acetabular Cup consists of disposable cement spacer molds. The molds are comprised of a lower mold, an upper mold, an injector, and tightening clips. The lower mold has a fixed diameter and couples with one of three upper molds. The upper mold has five channels for air flow and four holes for clips. The injector connects to the upper mold for bone cement injection. Tightening clips secure the upper and lower molds. The system is filled with low viscosity antibiotic polymethylmethacrylate bone cement. After curing, the temporary spacer is removed and placed into the joint space for up to 180 days.
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