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510(k) Data Aggregation

    K Number
    K254053

    Validate with FDA (Live)

    Device Name
    APS Spear Locking Plate
    Manufacturer
    A Plus Biotechnology Co., Ltd.
    Date Cleared
    2026-03-17

    (90 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K101962,K033975
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The APS Spear Locking Plate System is indicated for use in small bone reconstruction, corrective osteotomies, and fracture fixation.

    2.4mm Locking Screw
    The 2.4mm Locking Screw is intended for use with the Spear Locking Plate in metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation.

    2.7mm Continuous Locking Screw
    The 2.7mm Continuous Locking Screw is intended for use with the Spear Locking Plate, for fixation and compression at the osteotomy or fracture site. It is suitable for metacarpal and metatarsal corrective osteotomies and fracture stabilization.

    Spear Locking Plate
    The Spear Locking Plate is intended for use in metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation.

    Spear Locking Plate II
    The Spear Locking Plate II is intended for metacarpal and metatarsal reconstruction, corrective osteotomies, and fracture fixation.

    Device Description

    The APS Spear Locking Plate System (2.4mm locking screw (0824-4302-xx); 2.7mm continuous locking screw (0827-2302-xx); Spear locking plate (1300-0005-xx) and Spear locking plate ii (1301-0005-xx)) is an internal fixation device consisting of anatomically contoured titanium plates and associated locking screws, designed for use in small bone reconstruction, corrective osteotomies, and fracture fixation. The system functions by engaging locking screws into threaded plate holes, forming a fixed-angle construct that stabilizes bone fragments. The implants are manufactured under rigid fixation principles. All components are manufactured from ELI alloy (ASTM F136, ISO 5832-3), a biocompatible material with proven use in orthopedic implants. The system includes 2.4 mm Locking Screws, 2.7 mm Continuous Locking Screws, Spear Locking Plates, and Spear Locking Plates II. These implants are CNC-machined, surface-finished, and laser-marked, followed by validated cleaning and packaging. Supplied sterile and intended for single use, the devices are sterilized by healthcare providers using moist heat (ISO 17665). Mechanical testing (ASTM F382, ASTM F543) confirms that the plates and screws provide strength, stability, and fatigue resistance comparable to predicate devices, while biocompatibility has been established under the ISO 10993 series.

    AI/ML Overview

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