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510(k) Data Aggregation

    K Number
    K112905
    Device Name
    COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
    Manufacturer
    BIOMET ORTHOPEDICS LLC.
    Date Cleared
    2012-05-24

    (234 days)

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

    BIOMET ORTHOPEDICS LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented 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. The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement. The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
    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 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. The Compress® Segmental Humeral Replacement System is a set of Compliant - Pre-Stress implants that replace the humeral stems that would normally be used during a proximal or distal humeral replacement surgery.
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