LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071563
    Device Name
    PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2007-08-08

    (62 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K062216,K033669,K051735,K993106,K011335
    Predicate For
    K081106,K090675,K123055,K140357,K173166,K173293,K213126
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PERI-LOC* Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC° contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC* VLP One-Third Tubular Locking Plates are indicated for fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

    Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.

    Device Description

    PERI-LOC™ Periarticular Locked Plating System - VLP Plates and Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K062216. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ VLP locking bone plates and locking/non-locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

    AI/ML Overview

    The provided text is a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System. This type of submission is for medical devices and does not contain acceptance criteria or a study that evaluates the performance of an AI/ML powered device.

    Instead, a 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device. This typically involves:

    • Comparison of technological characteristics: Showing the new device has similar design features, materials, and technological properties to the predicate.
    • Comparison of indications for use: Demonstrating that the new device is intended for the same population and conditions as the predicate.
    • Performance testing (mechanical/biocompatibility): This usually involves non-clinical bench testing to ensure the device meets specified engineering and safety standards, but these are not the same as clinical studies evaluating AI model performance.

    Therefore, I cannot extract the requested information from the provided text because it describes a traditional medical device (bone plates and screws), not an AI/ML powered device. The questions you've asked are relevant for AI/ML device submissions, which typically require different types of studies and acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1