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510(k) Data Aggregation

    K Number
    K243963
    Device Name
    Pediatric Plating Platform Hip
    Manufacturer
    OrthoPediatrics Corp.
    Date Cleared
    2025-04-29

    (127 days)

    Product Code
    HRS,HWC,JDO
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K162307,K111086,K210837,K993289,K072095
    Why did this record match?
    Device Name :

    Pediatric Plating Platform Hip

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

    The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.

    Device Description

    The Pediatric Plating Platform | Hip consists of plates, screws and connector bolts in a variety of sizes and shapes to accommodate different anatomic requirements. The Pediatric Plating Platform | Hip also includes surgical instruments.

    The Pediatric Plating Platform | Hip offers a selection of plates and screws specifically designed for deformity correction and trauma of the proximal femur. Plates are offered in a variety of angles and offsets to accommodate the anatomy following planned osteotomies or fixation of traumatic fractures. The plate is fixed to the bone via the choice of beam, locking and non-locking screws to ensure stable fixation and healing. The Pediatric Plating Platform | Hip is available in infant, child and adolescent families providing a suitable range of screw and plate sizes.

    The implants of the Pediatric Plating Platform | Hip are manufactured from implant grade 316LVM Stainless Steel (ASTM F138 and/or F139).

    AI/ML Overview

    The provided FDA 510(k) clearance letter for the Pediatric Plating Platform | Hip is for a physical medical device (bone plates and screws), not an AI/Software as a Medical Device (SaMD).

    Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/SaMD (which typically involves metrics like sensitivity, specificity, AUC, human reader studies, etc.) is not applicable to this submission.

    The FDA clearance relies on traditional medical device testing and comparisons for physical implants, such as:

    • Biocompatibility: Based on the prior use of the OrthoPediatric Corp's Locking Proximal Femur System which shares the same materials, manufacturing, and cleaning processes.
    • MR Safety: Evaluated using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, determined to be MR Conditional.
    • Mechanical Performance: Included Torsional Properties, Insertion and Removal Torque, Axial Pullout Strength (per ASTM F543), and Static Compression Bending and Fatigue Compression Bending (per ASTM F384). The results demonstrated substantially equivalent mechanical performance to the predicate device.

    There is no mention of:

    • AI algorithm performance metrics.
    • Test sets, training sets, or data provenance for AI models.
    • Ground truth established by experts for AI.*
    • Multi-reader multi-case (MRMC) studies for AI assistance.
    • Standalone AI performance.

    In summary, a table of acceptance criteria and reported device performance, sample size, expert qualifications, and adjudication methods for AI/SaMD are not part of this 510(k) submission as it is for a physical orthopedic implant, not an AI software product.

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