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510(k) Data Aggregation

    K Number
    K251680

    Validate with FDA (Live)

    Device Name
    Biosteon® Screw
    Manufacturer
    Biocomposites, Ltd.
    Date Cleared
    2026-02-17

    (263 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K202535,K003641
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), lateral collateral ligament (LCL), and medial patellofemoral ligament (MPFL) reconstruction procedures where the surgeon:
    • places the graft in tibial and/or femoral tunnels; and
    • inserts between the tunnel wall and graft to hold the graft in place

    The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL, PCL, MCL, LCL, and MPFL reconstruction.

    The Bioston™ Screw is used to provide interference fixation during femoral and/or patellar tibial fixation in ACL, PCL, MCL, LCL, and MPFL reconstruction using a soft tissue graft (semi-tendonodesis gracilis).

    Device Description

    The Biosteon® Screw is a cannulated, tapered, sterile, single-use interference screw made of an absorbable polymer that will gradually be absorbed into the body. The Biosteon® Screw is manufactured from a mixture of hydroxyapatite (HA) and poly(L-lactide) (PLLA). The device is available in diameters 6mm - 12mm, and lengths 23mm -35mm.

    AI/ML Overview

    N/A

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