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510(k) Data Aggregation

    K Number
    K241059
    Device Name
    Pantheon Proximal Femur Reconstruction (PFR) System
    Manufacturer
    Adler Ortho S.p.A
    Date Cleared
    2025-01-13

    (270 days)

    Product Code
    LPH, JDI, LZO, MBL
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    Adler Ortho S.p.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor. The FIXA Ti-Por cup is intended for cementless use.
    Device Description
    The Pantheon PFR System is manufactured of Ti6A14V (except for femoral heads which are made of CoCrMo or ceramic and acetabular inserts made of cross-linked UHMWPE) and includes various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The Pantheon PFR System consists of: - Pantheon Proximal Bodies made of Ti6Al4V Alloy additively manufactured. - CoCrMo Alloy Femoral Heads Taper 12/14 - Biolox Delta Ceramic Femoral Heads Taper 12/14 - Pantheon Shaft made of Ti6Al4V Alloy - Pantheon Bridging Collars made of Ti6Al4V Alloy additively manufactured - Pantheon Cylindrical Bridging Collars made of Ti6A14V Alloy additively manufactured - Pantheon Salvage Stem (Cemented) made of Ti6Al4V Alloy - Pantheon Salvage Stem (Uncemented) made of Ti6A14V alloy - Pantheon Proximal Body Locking Screw made of Ti6A14V Alloy - Pantheon Salvage Plate Compression Screws made of Ti6Al4V Alloy - Pantheon Salvage Plate with Spikes made of Ti6A14V Alloy - Fixa Ti-Por Cup Acetabular Shells made of Ti6Al4V Alloy additively manufactured. - Titanium Acetabular Screws made of Ti6A14V Alloy. - Acetabular Inserts Flat made of Cross-Linked PE. - Acetabular Inserts 15° Lipped made of Cross-Linked PE.
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