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510(k) Data Aggregation

    K Number
    K221135
    Device Name
    X-Twist PEEK Suture Anchor
    Manufacturer
    Parcus Medical LLC
    Date Cleared
    2022-05-19

    (30 days)

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

    Parcus Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-Twist PEEK Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications: Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
    Device Description
    The X-Twist PEEK Suture Anchor consists of an implantable anchor and anchor tip that are provided assembled to a driver. Retention suture(s) or suture tapes(s) are preloaded through the driver cannulation to secure the anchor tip onto the driver shaft. The anchor tip can be loaded with additional suture(s) or suture tapes(s) if needed for the intended surgical procedure. Clockwise rotation of the driver allows for advancement of the fully threaded anchor and anchor tip into the prepared bone socket to serve as the point of fixation for soft tissue repair.
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    K Number
    K212739
    Device Name
    ActiFlip
    Manufacturer
    Parcus Medical LLC.
    Date Cleared
    2021-10-06

    (37 days)

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

    Parcus Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction. The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.
    Device Description
    The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.
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