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510(k) Data Aggregation

    K Number
    K251732

    Validate with FDA (Live)

    Device Name
    Wrist Fracture System
    Manufacturer
    Met One Technologies, LLC
    Date Cleared
    2026-02-12

    (251 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K172170,K222637,K233154,K233311
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wrist Fracture System Distal Radius Plate is indicated for fixation of fractures, osteotomies, and non-unions of the distal radius.

    The Wrist Fracture System Dorsal Bridge Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.

    Device Description

    The Met One Technologies Wrist Fracture System is an implant system for the repair of radius fractures. Included in the system are titanium fracture plates, titanium bone screws, k-wires, and surgical instrumentation.

    Distal radius plates are intended for fixation of fractures, osteotomies and non-unions of the distal radius. Various widths and lengths of distal radius plates are available to accommodate differences in patient anatomy. The dorsal bridge plate is intended for fixation of fractures, osteotomies and non-unions of the radius. One size of dorsal bridge plate is available. All plates are offered in multiple titanium grades and production processes which includes grade 23 titanium (Ti-6Al-4V ELI) per ASTM F 136, grade 4 titanium (CP Ti) per ASTM F67, additively manufactured grade 23 titanium (Ti-6Al-4V ELI) per ASTM F3001, and additively manufactured grade 1 titanium (CP Ti). Each plate is designed with pre-determined hole angles and incorporates a self-locking mechanism to resist movement of the screw relative to the plate.

    Screws are available in two diameters (2.4 mm and 3.0 mm) and in a variety of lengths to accommodate differences in patient anatomy. All screws are manufactured from grade 23 titanium (Ti-6Al-4V ELI) per ASTM F136. The 2.4 mm screws are designed to allow a 30° cone of variable angle locking when used with fracture plates. The 3.0 mm screws are intended to be inserted orthogonal to the bone plate in predetermined holes where they self-lock with the fracture plate.

    K-wires are available in 1.1 mm diameter and are used for temporary fixation or permanent implantation in specifically designed holes in fracture plates. K-wires are manufactured from 316L stainless steel per ASTM F138 or grade 23 titanium (Ti-6Al-4V ELI) per ASTM F136.

    Instruments are provided for the preparation, implantation, and removal of implants. All instruments are reusable.

    AI/ML Overview

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