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    K Number
    K252743

    Validate with FDA (Live)

    Device Name
    STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
    Manufacturer
    Ethicon, Inc.
    Date Cleared
    2025-12-22

    (116 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    18 - 74
    Reference & Predicate Devices
    K192144,K182873
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

    Device Description

    STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are antibacterial monofilament, synthetic absorbable devices consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4H6O3)X. The devices contain IRGACARE® MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 μg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

    The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are available in Unidirectional and Bidirectional forms:

    • The STRATAFIX™ Spiral PDS™ Plus Unidirectional Knotless Tissue Control Devices consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDS™ Plus Unidirectional Knotless Tissue Control Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

    • The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The device also contains an un-barbed center transition zone that facilitates the initiation of the device use. The barbs allow for tissue approximation without the need to tie surgical knots.

    While the formation of barbs in the STRATAFIX™ Spiral PDS™ Plus Devices reduce the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDS™ Plus Devices can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDS™ Plus Devices suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.

    AI/ML Overview

    N/A

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