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    K Number
    K252191

    Validate with FDA (Live)

    Device Name
    BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
    Manufacturer
    Bonebridge AG
    Date Cleared
    2025-12-17

    (156 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 999
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BRUSIO Trauma Toolbox System is indicated for internal fixation of fractures, osteotomies and nonunions of bones and bone fragments of the appendicular skeleton that are appropriate for the implant size in adult patients. When used in the clavicle, scapula, humerus, olecranon, pelvis, femur, tibia or fibula, the BRUSIO Trauma Toolbox System is intended only for non-load-bearing stabilization and reduction.

    The TAMINA, TAMINA Long and TAMINA TF Proximal Humerus System is indicated for
    • Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic bone
    • Pseudarthroses (non-unions) of the proximal humerus
    • Osteotomies of the proximal humerus

    Device Description

    The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject devices BRUSIO Trauma Toolbox System and TAMINA 3.5mm Proximal Humerus System are variants of the Bonebridge Osteosynthesis Plating System.

    The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139).

    All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

    AI/ML Overview

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