The United States Patent and Trademark Office issues patent to Fusion Orthopedics LLC for the surgically implantable TopLock soft tissue anchor medical device. The now patented TopLock Anchors are a new implant system for Fusion Orthopedics, LLC and release of this system to the market is not permitted until FDA clearance is obtained. Request for 510k clearance was submitted in late 2019 by Fusion Orthopedics, LLC. A release date for the TopLock medical device is currently unknown.
The TopLock Anchor system will feature PEEK suture anchors offered in five different sizes to address a variety of patient anatomy and indications. The 5.0 mm, 4.5 mm and 3.8 mm anchors lock suture after insertion into a patient. The TopLock Anchor system is a truly top locking mechanism for knotless Suture Anchor fixation. In addition, the top locking mechanism can afford rotary adjustments to decrease fraying of suture.
In addition there is a traditional anchor system available in 3.5mm diameter with a barbed and a threaded configuration.
Specialized instruments will be made primarily of surgical grade stainless steel (ASTM F899). The implant and associated instrumentation will be supplied sterile and non-sterile.
Fusion has a pending FDA clearance on the now patented TopLock Anchor System to secure soft tissue to bone of:
The Shoulder
Bankart Repair
SLAP Lesion Repair Acromio-Clavicular Separation Rotator Cuff Repair
Capsule Repair
Biceps Tenodesis
Deltoid Repair
Pectoralis Major Tendon Repair
The Elbow
Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction
Tennis Elbow Repair
Triceps Tendon Repair
The Hand and Wrist
Scapholunate Ligament Reconstruction
Ulnar / Radial Collateral Ligament Reconstruction Distal Radio-Ulnar Joint Repair
Triangular Fibrocartilage Complex Repair Extensor Tendon Repair
Flexor Tendon Repair
Tendon Transfer Surgery
The Knee
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Posterior Oblique Ligament Repair
Extra Capsular Reconstruction
Iliotibial Band Tenodesis
Patellar Tendon Repair
Quadriceps Tenon Repair
Tibial Fixation for ACL Reconstruction Meniscus Repair
Medial Patellofemoral Ligament Reconstruction
The Ankle and Foot
Lateral Ligament Stabilization Repair
Medial Ligament Stabilization Repair
Achilles Tendon Repair / Reconstruction
Metatarsal Ligament Repair
Hallux Valgus Reconstruction
Mid and Rear Foot Reconstruction
Spring Ligament Reconstruction
Syndesmosis Ligament Repair
Reconstruction of Claw Toe Deformity
Repair of Tibialis Anterior, Tibialis Posterior and Peroneal Tendon Tears Tendon Transfer Surgery
The TopLock Anchors achieve fixation of soft tissue to bone with barbed or threaded implants that limit the movement of suture to encourage a stable construct. The various anchor sizes and types of suture allow for a wide range of procedures and surgeon preferences.
**Disclaimer: The TopLock Anchor System is pending FDA clearance and the projected clearence is unknown.