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510(k) Data Aggregation

    K Number
    K964259
    Device Name
    SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1997-01-09

    (76 days)

    Product Code
    JDO
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K190750
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

    Device Description

    Synthes DHS/DCS One-Step Lag Screw has a 12.7 mm or a 14.0 mm thread diameter and is available in various lengths. The DHS/DCS One-Step is manufactured from stainless steel. Additionally, Synthes Ti-DHS/DCS One-Step Lag Screw and DHS/DCS Lag Screws have a 12.7 mm or a 14.0 mm thread diameter and is available in various lengths. The Ti-DHS/DCS One-The DHS/DCS Lag Screw is Step Lag Screw is manufactured from Titanium Alloy. manufactured from stainless steel. Synthes DHS/DCS One-Step Lag Screw will be provided sterile; gamma radiation will be used to sterilize the device.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving that a device meets those criteria.

    This document describes the Synthes DHS/DCS One-Step Lag Screws, their intended use, and a comparison to other similar Synthes lag screws. It primarily focuses on:

    • Device Description:

      • Synthes DHS/DCS One-Step Lag Screws for use with Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates.
      • Intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures.
      • Available in 12.7 mm or 14.0 mm thread diameter and various lengths, manufactured from stainless steel.
      • Sterilized by gamma radiation.

    • Comparison/Equivalence:

      • States that Synthes DHS/DCS One-Step Lag Screws are compared to Synthes Ti DHS/DCS Lag Screws and Synthes DHS/DCS Lag Screws.
      • Mentions that Ti-DHS/DCS One-Step Lag Screws are made from Titanium Alloy, and DHS/DCS Lag Screws are made from stainless steel.
      • Concludes that the Synthes DHS/DCS One-Step Lag Screw is equivalent to the Synthes Ti-DHS/DCS One-Step Lag Screw and the Synthes DHS/DCS Lag Screw.

    No study details, acceptance criteria, or performance metrics are provided in this document. It reads like a summary for regulatory submission (e.g., a 510(k) summary) rather than a clinical study report. Therefore, I cannot extract the requested information.

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