LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K252949

    Validate with FDA (Live)

    Device Name
    Geminus Volar Distal Radius Plating System
    Manufacturer
    Skeletal Dynamics Inc
    Date Cleared
    2025-11-13

    (58 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K935481,K122310,K122737,K242436,K241815,K963798,K182492
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K935481, K122310, K122737, K242436, K241815, K963798

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Skeletal Dynamics Geminus Volar Distal Radius Plating System is intended for fixation of fractures and osteotomies of the distal radius.

    Device Description

    The current Geminus Volar Distal Radius Plating System includes medical grade titanium alloy (Ti 6Al-V4 ELI) bone plates offered in 12 sizes, an ulnar hook plate, Cobalt-Chromium-Molybdenum (CoCrMo) and titanium alloy (Ti 6Al-V4 ELI) bone screws and pegs, and specialized instrumentation for the repair of distal radius and osteotomies. The system also includes the Radial Hook Plate extensions to buttress a volar marginal fragment, and the Buttress Button assembly to capture and hold small dorsal corner fractures.

    The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

    The Geminus Volar Distal Radius Plating System is comprised of:

    System ComponentsMaterial(s)Standard(s)
    Geminus Volar Distal Radius PlatesTi 6Al-V4 ELIASTM F136
    Locking Smooth PegsLocking Threaded PegsHigh Compression Locking PegsNon-Locking Threaded PegsCortical Non-Locking ScrewsCortical Locking ScrewsTi 6Al-V4 ELIASTM F136
    Washer ButtonTi 6Al-V4 ELIASTM F136
    Polyaxial Locking ScrewsCoCrMoASTM F1537
    Geminus Hook Plate ScrewsTi 6Al-V4 ELIASTM F136
    Geminus Ulnar Hook PlateTi 6Al-V4 ELIASTM F136
    Geminus Radial Hook PlateTi 6Al-V4 ELIASTM F136
    Geminus Buttress Button AssemblyTi 6Al-V4 ELICP Ti Grade 2ASTM F136ASTM F86
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K162825

    Validate with FDA (Live)

    Device Name
    CAPTIVATE™ Compression Screws
    Manufacturer
    GLOBUS MEDICAL, INC.
    Date Cleared
    2017-05-01

    (206 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K090952,K122737,K021932,K143039,K111994,K090949
    Predicate For
    K222409,K222967
    Why did this record match?
    Reference Devices :

    K090952, K122737, K021932

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CAPTIVATE™ Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

    CAPTIVATE™ VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

    CAPTIVATE™ VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

    Device Description

    CAPTIVATE™ Compression Screws consist of bone screws designed to compact juxtaposed bone for reconstruction and enhanced arthrodesis. The implants are available in various diameters and lengths to accommodate patient anatomy, with headless, partially or fully threaded, solid or cannulated, and variable length (VL) options. CAPTIVATE™ implants are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537 and F138.

    AI/ML Overview

    This document is a 510(k) premarket notification summary for CAPTIVATE™ Compression Screws. It describes the device and its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in human clinical performance metrics.

    The "Performance Data" section discusses mechanical testing of the device (bending strength, torsional strength, driving torque, pullout testing, cyclic bending, and bacterial endotoxin testing). This type of testing is typically done to ensure the physical integrity and safety of the device itself, rather than to evaluate its performance in a clinical setting against specific clinical acceptance criteria for human outcomes.

    Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially concerning clinical performance, AI performance, MRMC studies, or standalone algorithm performance) cannot be extracted from the provided text. The document focuses on regulatory clearance based on substantial equivalence to existing devices through similar technological characteristics and laboratory-based mechanical performance data.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1