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510(k) Data Aggregation

    K Number
    K142746
    Device Name
    G7 Finned Acetabular Shell
    Manufacturer
    BIOMET MANUFACTUTING CORP.
    Date Cleared
    2014-12-29

    (96 days)

    Product Code
    LPH, JDI, KWZ, LZO, OQG, OQH, OQI, PBI
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET MANUFACTUTING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Noninflammatory 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. 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. Indications for Biomet G7 Freedom Constrained Liners: The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
    Device Description
    The G7™ Finned Acetabular Shell is a medical device intended to be used as part of a hip joint replacement in Total Hip Arthroplasty procedure by qualified surgeons in the field of orthopaedics. The G7™ Finned Acetabular Shell is utilized to replace the acetabulum, and will be used in conjunction with the existing G7 Acetabular Cup bearing system (K121874), instruments and modular femoral system. The G7™ Finned Acetabular Shell will have the same internal geometry, liner locking system and PPS coating as the G7 Acetabular Cup System Shells (K121874) but will feature fins to provide improved primary fixation and anti-rotational stability.
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    K Number
    K123297
    Device Name
    COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
    Manufacturer
    BIOMET MANUFACTUTING CORP.
    Date Cleared
    2012-11-20

    (29 days)

    Product Code
    MBF
    Regulation Number
    888.3670
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET MANUFACTUTING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compress® Segmental Humeral Replacement System is indicated for: 1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
    Device Description
    The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The Compress® Segmental Humeral Replacement System components are intended for uncemented use. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
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