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510(k) Data Aggregation

    K Number
    K961625
    Device Name
    QUATROLOC FEMORAL COMPONENT & HEAD
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    1996-09-10

    (137 days)

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

    QUATROLOC FEMORAL COMPONENT & HEAD

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

    This device is intended to be used for :

    • noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
      1. rheumatoid arthritis,
    • correction of functional deformity, 3.
    • revision procedures where other treatments or devices have failed, and 4.
    • treatment of non-unions, femoral neck and trochanteric fractures of the proximal 5. femur with head involvement, unmanageable using other techniques.
    Device Description

    The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AJ- 4V (ASTM 1472) stem with a tapered proximal end intended to seat a conventional cobalt-chrome modular spheric articular interface. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. Th distal will be a smooth taper A-P and will be step-cut with parallel sides M-L. The proximal stem will be porous coated with commercially pure titanium beads on all surfaces excluding the articular interface trunnion.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device, specifically a modular femoral component and head for hip replacement. This document primarily focuses on describing the device, its intended use, and manufacturing materials.

    It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any form of clinical or performance data that would typically be described in the context of device validation or verification studies.

    Therefore, I cannot provide the requested information. The document is a regulatory submission summary, not a study report.

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