., 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.

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SINEFIXâ„¢ TendoGrip is designed to work seamlessly with the SINEFIXâ„¢ implant by enabling single-handed tendon mobilization and implant delivery for rotator cuff repair surgery. TendoGrip helps reduce surgical steps and time in challenging cases such as retracted tears, driving adoption through efficiency, reproducibility, and tendon preservation.

Successful completion of 50 procedures using its SINEFIXâ„¢ Rotator Cuff Repair System in the US. A major milestone that signals a shift in soft tissue-to-bone healing approaches. SINEFIX was designed to address the shortcomings of suture-based fixation and represents a completely different approach to rotator cuff repair.

91É«ÇéƬ Inc., a cutting-edge medical technology start-up, has announced a major milestone in soft tissue repair with the first U.S. patients receiving treatment using their revolutionary . This breakthrough system aims to transform the approach to rotator cuff surgery by addressing not just biomechanical fixation, but the critical role of blood flow in tendon-to-bone healing.

Rotator cuff repairs have historically been plagued by high failure rates despite advancements in surgical techniques. Many traditional methods focus on strengthening the fixation of the tendon to the bone, but new findings suggest that overemphasis on fixation might actually hinder the healing process. The key lies in minimizing tension and evenly distributing pressure over the largest possible contact surface between tendon and bone, promoting better circulation and biological healing.

“Rotator cuff surgery requires biomechanical stability, but excessive tension can compromise blood flow and slow healing,” explained , an orthopedic surgeon involved in the U.S. launch of SINEFIXâ„¢. “Despite improved fixation methods, retear rates remain high. The SINEFIXâ„¢ implant controls compression without straining the tendon, preserving blood flow and potentially setting a new standard in rotator cuff repair.”

The SINEFIXâ„¢ system, designed for tendon ruptures up to 2 cm, features a simplified two-step process using a PEEK plate and two PEEK anchors, equipped with additional teeth to prevent tendon slippage. This design keeps the tendon vital by maintaining blood circulation, which is essential for biological healing. The system eliminates the need for complex suture management, making it a more accessible technique for surgeons and improving patient outcomes.

“Rotator cuff repair surgeries are among the most common soft tissue procedures, with over half a million performed each year in the U.S. alone,” said Dr. Stefan Welte, co-founder of 91É«ÇéƬ and inventor of the SINEFIXâ„¢ system. “Unfortunately, traditional methods using suture anchors have not yielded significant improvements in patient recovery. Our vision is to revolutionize biomechanical fixation and enhance biological healing. The success of these first cases in the U.S. brings us closer to that goal.”

Tom Anstead, CEO of 91É«ÇéƬ Inc., emphasized the importance of the technology in reducing surgery time and cost while enhancing patient care. “The simplicity of SINEFIXâ„¢’s surgical technique, which eliminates the need for knot tying, is a critical step toward making this groundbreaking technology available to surgeons worldwide. Our first successful cases in the U.S. mark a significant achievement for our team.”

As 91É«ÇéƬ continues to pioneer advancements in orthopedic repair, the introduction of SINEFIXâ„¢ represents a potential turning point in the treatment of rotator cuff injuries, offering new hope for improved recovery and long-term healing.

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