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    K Number
    K170339
    Device Name
    Summit Hip System
    Manufacturer
    DePuy Orthopaedics, Inc.
    Date Cleared
    2018-04-26

    (448 days)

    Product Code
    LZO,JDI,KWL,KWY,LPH,LWJ,LZY,MEH
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K001991
    Why did this record match?
    Reference Devices :

    K011489 Summit Duofix Hip Prosthesis, K013352 Summit Cemented Hip Prosthesis, K023453 DePuy Cemented

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

    Total hip replacement is indicated in the following conditions:

    1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
    2. Avascular necrosis of the femoral head.
    3. Acute traumatic fracture of the femoral head or neck.
    4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
    5. Certain cases of ankylosis.

    Hemi hip replacement is indicated in the following conditions:

    1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
    2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
    3. Avascular necrosis of the femoral head.
    4. Non-union of femoral neck fractures.
    5. Certain high subcapital and femoral neck fractures in the elderly.
    6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
    7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

    The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
    The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.

    Device Description

    The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices.
    The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
    The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
    The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only.
    The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only.
    The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.

    AI/ML Overview

    This is a 510(k) summary for the Summit Hip System, which is a medical device. This document does not describe acceptance criteria for an AI/ML device, nor does it contain information about a study proving such a device meets acceptance criteria. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence of the Summit Hip System to predicate devices.

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