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    K Number
    K254055

    Validate with FDA (Live)

    Device Name
    OSSIOfiber® Suture Anchor
    Manufacturer
    OSSIO , Ltd.
    Date Cleared
    2026-02-24

    (69 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    2 - 21
    Reference & Predicate Devices
    K231272,K243760,K252022,K251309
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231272, K243760, K252022

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

    The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation, in the following procedures:

    • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
    • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
    • Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 Anchors only).
    • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
    • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).
    Device Description

    The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

    The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

    AI/ML Overview

    N/A

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