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510(k) Data Aggregation

    K Number
    K053293
    Device Name
    ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Date Cleared
    2006-02-16

    (83 days)

    Product Code
    LPH,MBL
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENCOMPASS 1017 AND 1217 EXTENDED PRESS-FIT HIP STEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only.

      1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
      1. Previously failed surgery.
      1. Proximal femoral neck fractures or dislocation.
      1. Idiopathic avascular necrosis of the femoral head.
      1. Non-union of proximal femoral neck fractures.
      1. Treatment of fractures that are unmanageable using other forms of therapy.
      1. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the Encompass™ Press-Fit Hip Stem. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information.

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