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510(k) Data Aggregation

    K Number
    K223779
    Device Name
    EMPOWR™ blade stem
    Manufacturer
    Date Cleared
    2023-02-13

    (59 days)

    Product Code
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    Encore Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. Joint replacement is indicated for patients suffering from disability due to: - noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; - rheumatoid arthritis; - correction of functional deformity; - femoral fracture; and - revision procedures where other treatments or devices have failed. This stem is to be press-fit. This stem is intended for cementless use.
    Device Description
    The EMPOWR™ blade stem represents the latest generation of a press-fit, porous coated, wedge style femoral stem. Building on the design principles of its predicate, Linear® Hip Stem, the EMPOWR™ blade stem system features enhancements such as addition of coxa vara offset, neck angle update, and distal angle reduction for wider application. The EMPOWR™ blade stem is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures in all age groups. It offers a stem design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation. The EMPOWR™ blade stem features streamlined and accurate instrumentation that is highly adaptable to any surgical approach.
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