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510(k) Data Aggregation

    K Number
    K243726
    Device Name
    Osprey Suture Anchor
    Manufacturer
    Responsive Arthroscopy, Inc.
    Date Cleared
    2025-01-30

    (58 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Responsive Arthroscopy, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osprey Suture Anchor is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, and elbow in the following procedures: - Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot reconstruction, Metatarsal Ligament Repair, Bunionectomy. - Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Meniscal Root Repair. Secondary fixation for ACL/PCL reconstruction. - Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
    Device Description
    The Osprey Suture Anchor is an anchor device comprised of polyether ether ketone (PEEK) material that is designed for the fixation of soft tissue to bone. The device creates a secure point for the fixation of soft tissue to bone when inserted through a pilot hole and deployed within bone. The system features a knotless 5.35mm diameter suture anchor preloaded on an inserter with two suture pull tabs. The system also includes two 2.3mm repair suture tapes and an auxiliary #0 suture that holds the anchor in place on the inserter until use and is then discarded. The Osprey system is designed to be used with manual surgical instruments including a 2.4mm guide drill, a 5.0mm cannulated drill, and a suture passer to aid in device placement. The Osprey Suture Anchor is pre-loaded on disposable inserters and provided to the end user sterile via ethylene oxide (EO) sterilization, while the reusable instruments (drills and suture passer) are non-sterile and are intended to be sterilized by the end user. The Responsive Arthroscopy Osprey Suture anchors and instrumentation are designed to accommodate an arthroscopic surgical approach.
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