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510(k) Data Aggregation

    K Number
    K211843

    Validate with FDA (Live)

    Device Name
    PolyLock Plating System
    Manufacturer
    Fusion Orthopedics
    Date Cleared
    2022-03-04

    (262 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K202959,K203511
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand, foot, and ankle, including the distal tibia, talus, and calcaneus. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

    Device Description

    The PolyLock Plating System consists of various shapes and sizes of plates for the management of orthopedic osteotomies, reconstruction, and trauma of the foot, ankle, and hand. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device (PolyLock Plating System). It does not contain any information about an AI/ML-based medical device study, acceptance criteria, or performance data related to AI/ML.

    Instead, it's about a metallic bone fixation appliance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:

    • "Engineering rational was performed to show substantial performance equivalence."
    • "No clinical studies were performed."

    Therefore, I cannot provide details on the requested points because the provided text does not describe an AI/ML study. It details the submission of a physical medical device.

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