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510(k) Data Aggregation

    K Number
    K252401

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-12

    (224 days)

    Product Code
    Regulation Number
    888.3353
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The implaFit® short stems are intended to be used in total hip arthroplasty for the following indications:

    • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
    • Rheumatoid arthritis;
    • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
    • Revision of previously failed total hip arthroplasty.

    The implaFit® short stems are intended for uncemented, press-fit fixation.

    The implaFit® short stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head System for the following indications:

    • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
    • Rheumatoid arthritis
    • Correction of functional deformity
    • Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
    Device Description

    The components introduced with this submission are intended to mate with other previously cleared components to make a complete prosthesis. The implaFit® short stem with collar cementless are offered in standard and lateralized offset versions. The components included in this submission consist of titanium alloy femoral hip stems, used in total and hemi hip arthroplasty and are intended for uncemented press fit application.

    AI/ML Overview

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