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510(k) Data Aggregation

    K Number
    K983592
    Device Name
    SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Date Cleared
    1999-01-28

    (107 days)

    Product Code
    HWC,GAT,MAI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS

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

    The Sulzer Orthopedics Sysorb Interference Screws are intended for use in the following diagnostic indications:

    1. Tibial and femoral fixation (primary anchorage) of the autologous tendon-transplants as it is used in the reconstruction of the cruciate ligaments of the human knee.
    Device Description

    The Sulzer Orthopedics Sysorb Interference Screws are a bioresorbable interference screw used in attachment of autologous tendon tranfers in cruciate ligament reconstruction. The Sysorb interference screws are manufactured from the bioresorbable material Poly (D,L-Lactide) (Resomer R208), an amorphous polymer derivative of lactic acid. The screw provides an initial interference fit fixation of the tissue graft and resorbs over time as the graft is naturally incorporated into the surrounding structure.
    The Sysorb Interference Screw uses a nearly symmetrical thread profile which takes into account both the strength of the material and the relative strength of cancellous bone. The design also allows the screw to be introduced without drilling or tapping. A continuous "turbine" shaped driving feature allows torque to be applied along the complete length of the screw upon implantation, thus minimizing the potential for fracture of the implant.

    AI/ML Overview

    The provided document is a 510(k) summary for the Sulzer Orthopedics Sysorb Interference Screw. This type of document is for a medical device that does not perform diagnostic functions or involve AI. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not applicable to this submission.

    The document discusses the product description, its intended use, and its substantial equivalence to other marketed resorbable interference screws. It also includes an FDA letter confirming the device's substantial equivalence.

    In summary, none of the requested information about acceptance criteria, study design, expert ground truth, or AI performance can be extracted from this document as it pertains to a non-AI, non-diagnostic medical device.

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