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510(k) Data Aggregation

    K Number
    K221758
    Device Name
    SMR Stemless Anatomic
    Manufacturer
    LimaCorporate S.p.A
    Date Cleared
    2023-03-17

    (274 days)

    Product Code
    PKC
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K100858,K110598,K110847,K113254,K133349,K143256,K153722,K163397,K161476,K143552,K171858,K173388,K212800,K183194
    Why did this record match?
    Reference Devices :

    K100858, K110598, K110847, K113254, K133349, K143256, K153722, K163397, K161476, K143552, K171858, K173388

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

    The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to:

    · non-inflammatory degenerative joint disease including osteoarthritis;

    • revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant);

    · glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

    The SMR Stemless Anatomic is intended for uncemented use.

    Device Description

    The SMR Stemless Anatomic is a modular system comprised of a stemless core and humeral head adaptor taper. The modular components are available in various sizes and are interchangeable allowing for independent sizing and positioning. The SMR humeral heads were previously cleared (K161476, K100858), and the SMR Stemless Anatomic is compatible with the previously cleared Cemented SMR metal back Glenoid Components (K113254, K133349, K143256), Cemented SMR all polyethylene glenoid components (K100858, K130642, K153722), and SMR TT Hybrid Glenoid System (K163397).

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "SMR Stemless Anatomic." It's not a study report of an AI/ML powered medical device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, study methodologies for AI performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML product.

    The document discusses performance testing for a mechanical orthopedic implant, specifically a shoulder joint prosthesis, covering aspects like fatigue, micromotion, and pull-out strength. It also mentions "Clinical Data" related to the device's success in patients, comparing it to a predicate device. This is a traditional medical device clearance, not an AI/ML software as a medical device (SaMD) or AI-powered medical device.

    Therefore, I cannot extract the requested information (table of acceptance criteria with AI performance, sample sizes for AI test sets, expert details for AI ground truth, MRMC studies, etc.) from this document. The concepts and methodologies described in the prompt are specific to the evaluation and clearance of AI/ML-driven medical devices, which this document does not concern.

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