Fixed tendon, ligament - Vietnam Registration 2401077ĐKLH/BYT-HTTB

Purpose of Use These devices are intended to be used to fix soft tissue to bone, including tendons or ligaments to bone, or bone to bone. The device is also used for reattachment of soft tissue (e.g., fixation of tendon and ligament grafts). The device may be used in both open and arthroscopic surgery. Indications for Use Specific indications: Knee: Anterior Cruciate Ligament (ACL) injury, Posterior Cruciate Ligament (PCL) injury (Repair/Reconstruction), Reconstruction of the long head of the biceps tendon, Improvement of the vastus medialis oblique (VMO), Posterior Cruciate Ligament (PCL) injury, Repair/Reconstruction of the medial collateral ligament (MCL) and lateral collateral ligament (LCL), Repair/Reconstruction of the torn patellar tendon (Patellar tendon or quadriceps tendon), Instability of the patella - Repair/Reconstruction of the patellar ligament (MPFL) (Trade names: BIOTEK, SOFTFIX, SOFTFIX-PK) Ankle/Forefoot: Lateral stabilization, Midfoot stabilization, Reconstruction of the Achilles tendon, Reconstruction of the midfoot and forefoot, Repair of the ligaments/tendons of the foot, Transfer of the toe tendons, Reconstruction of the navicular bone, Reconstruction of the deltoid muscle (Trade names: BIOTEK, SOFTFIX, SOFTFIX-PK) Elbow: Allograft of the biceps tendon, Reconstruction of the lateral collateral ligament/medial collateral ligament, Treatment of lateral epicondylitis/tennis elbow (Trade names: BIOTEK, SOFTFIX, SOFTFIX-PK) Shoulder: Repair of the labrum, Biceps tendon surgery (Trade names: BIOTEK, SOFTFIX-PK), Treatment of shoulder instability (Trade names: BIOTEK BIO LATARJET, LCSLATARJET) The surgeon must use his professional judgment to determine the appropriate screw size based on the specific indication, preferred surgical technique, and patient history.