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510(k) Data Aggregation

    K Number
    K243466
    Device Name
    Conformity Stem Extension Line, #0
    Manufacturer
    United Orthopedic Corporation
    Date Cleared
    2025-01-06

    (59 days)

    Product Code
    LZO,MEH
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K183312,K242249,K994078,K022520,K111546,K122504,K152439,K162957,K221675,K103497,K112463,K122185
    Why did this record match?
    Reference Devices :

    K183312, K242249, K994078, K022520, K111546, K122504, K152439, K162957, K221675, K103497, K112463, K122185

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

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

    1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement or total hip replacement.
    5. Certain cases of ankylosis.
      Conformity stem is for cementless use only.
    Device Description

    The subject device is an extension line of 510(K) cleared device Conformity stem, cementless (K183312, K242249), which introduces four new variations: (1) Conformity stem, #0; (2) Conformity stem, collared, #0; (3) Conformity stem, coxa vara, 125° STD, collared, #0; and (4) Conformity stem, short neck, collared #0. The indications, design rationales, materials, manufacturing process, and sterilization method of the subject devices are identical to the 510(k) cleared Conformity Stem, cementless (K183312, K242249).
    Conformity Stem can collocate with “United” metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

    • Conformity stem, #0
      Conformity stem, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity Stem, #1, #11 (K183312)The only differences in the items are the offset specifications and stem length.
    • Conformity stem, collared, #0
    • Conformity stem, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, collared, #1-11 (K183312). The material, coating thickness, neck angle (135°), and neck length (35.5mm) design are identical to 510 (k) cleared device Conformity stem, collared, #1, #11 (K183312).The only differences in the items are the offset specifications and stem length.
    • Conformity Stem, coxa vara, 125° STD, collared, #0
    • Conformity Stem, coxa vara, 125° STD, collared, #0 is an extension in terms of sizes to 510 (k) cleared device Conformity stem, coxa vara 125° STD, collared, #1-7 (K242249). The material, coating thickness, neck angle (125°), and neck length (32.5mm) design are identical to 510 (k) cleared device Conformity stem, 125° STD, collared, #1, #7 (K242249). The only differences in the items are the offset specifications and stem length.
    • Conformity Stem, short neck, collared #0
    • Conformity Stem, short neck, collared #0 is an extension in terms of sizes to 510 (k) cleared device Conformity Stem, short neck, collared, #1-7 (K183312 and K242249). The material, coating thickness, neck angle (135°), and neck length (28.5mm) design are identical to 510 (k) cleared device Conformity Stem, short neck, collared, #1, #7 (K183312 and K242249). The only differences in the items are the offset specifications and stem length.
    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (hip stem extension line). It details the device's identity, intended use, and comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/ML-driven device.

    The document primarily focuses on demonstrating substantial equivalence to existing legally marketed devices based on:

    1. Identical Indications for Use: The new device has the same indications as the predicate devices.
    2. Similar Technological Characteristics: The material, principle of operation, regulation number, product code, risk class, intended users, fixation method, surface coating, locking mechanism, and sterilization method are the same as the predicate device.
    3. Non-Clinical Performance Data: The submission includes tests like Range of Motion, Neck Fatigue Assessment, Stem Fatigue Test, Characterization of HA Plasma Spray Coating, and Usability Evaluation. These are standard engineering and material tests for orthopedic implants, not AI/ML performance metrics.

    Therefore, I cannot extract the requested information regarding:

    • A table of acceptance criteria and reported device performance (for AI/ML).
    • Sample size and data provenance for a test set (for AI/ML).
    • Number and qualifications of experts for ground truth (for AI/ML).
    • Adjudication method (for AI/ML).
    • MRMC comparative effectiveness study or human reader improvement with AI.
    • Standalone algorithm performance.
    • Type of ground truth (expert consensus, pathology, outcomes data, etc.) for AI/ML validation.
    • Sample size for the training set (for AI/ML).
    • How ground truth for the training set was established (for AI/ML).

    The document is about a physical orthopedic implant and its substantial equivalence based on mechanical and material testing, not an AI/ML diagnostic or assistive device.

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