Inovedis Inc., a cutting-edge orthopedic company, announced today that the U.S. Food and Drug Administration (FDA) has cleared expanded clinical applications for the SINEFIX Implant. Designed to replace traditional suture anchors for soft tissue-to-bone fixation, SINEFIX can now be used across a wider range of procedures, including:
- Shoulder: Rotator Cuff Repairs, Deltoid Repair.
- Foot/Ankle: Achilles Tendon Repair.
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Quadriceps Tendon Rupture Repair.
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
- Hip: Gluteus Medius Repair, Gluteus Minimus Repair.
SINEFIX is composed of a polyether ether ketone (PEEK) and includes one baseplate and two PEEK anchors, equipped with additional teeth to prevent tendon slippage. The innovative design addresses key limitations of traditional fixation methods.
Rather than relying on sutures that can concentrate force and cut through tendon, SINEFIX secures tissue by distributing compression across a broad surface area, effectively “stapling” the tendon to bone. This approach eliminates point-loading of sutures and distributes the pressure evenly across the repair footprint while also maintaining blood circulation at the repair site, which is critical to biological healing.