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510(k) Data Aggregation

    K Number
    K162957
    Device Name
    U2 Femoral Head
    Manufacturer
    UNITED ORTHOPEDIC CORPORATION
    Date Cleared
    2017-07-17

    (266 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K132207,K132455,K151316,K152530,K994078,K022520,K111546,K122504,K152439
    Predicate For
    K221675
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is indicated for use in hip arthroplasty in patients with the following conditions:

    1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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.

    This device is a single use implant and intended for cemented stem which is designed for cemented use only.

    Device Description

    UNITED U2 femoral head is a modification of the cleared UNITED femoral head (K994078, K022520, K111546, K122504 and K152439) which is intended to use in primary or revision total/hemi hip arthroplasty. U2 femoral heads include three series of products: U2 Femoral head, U2 Femoral head, 3/4 polished and U2 Femoral head, 4/5 polished.

    U2 femoral heads provide five different diameters of 22 mm, 26 mm, 32 mm and 36 mm. 22 mm is available in +0, +3, +6 and +9 mm of neck length, 26 mm is available in -2, +0. +3, +6 and +9 mm of neck length and 28 mm to 36 mm are available in -3, +0, +2.5. +5, +7.5 and +10 mm of neck length. A variety of diameters and neck lengths are available for various patient anatomies, adjustment of the tension of the ligaments, and reconstruction of the center of the physiological head of the femur.

    U2 femoral heads is design for compatibility with various types of UNITED Hip Stem (K062978, K003237, K003237, K151316, K111546, K111546, K152530, K123550, K132207). For total hip replacement, U2 femoral heads can be used in conjunction with U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262, K121777), U2 Ti Plasma Spray Cup (K050262, K121777), U2 Ti Porous Coated Cup (K111546) and U-Motion II Acetabular System (K122185, K132455). For hemi hip arthroplasty, U2 femoral heads can be used with U2 Bipolar Implant (K152439).

    AI/ML Overview

    The provided document describes the FDA 510(k) summary for the U2 Femoral Head prosthesis. This document does not describe the acceptance criteria and study proving device meets the acceptance criteria for an AI/ML device. Instead, it focuses on the substantial equivalence of a physical medical device (a femoral head implant) to previously cleared predicate devices.

    Therefore, the requested information elements (acceptance criteria, device performance table, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC study, standalone performance, training set details) are not available in the provided text.

    The document only states the following:

    Performance Data:

    • Non-clinical Performance:
      • Tests were conducted to evaluate safety and effectiveness.
      • Tests included:
        • Disassembly force between U2 femoral head and stem component.
        • Range of Motion.
        • Bacterial endotoxin testing, which met the endotoxin limit specified in USP <161>.
      • The performance data demonstrated the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
    • Clinical Performance Data/Information: None provided as a basis for substantial equivalence.

    This information pertains to the physical and biological properties of the implant, not to the performance of an AI/ML algorithm.

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