Inovedis Receives FDA Clearance of the SINEFIX™ Implant System for Rotator Cuff Repair

Jul 6, 2023

Company to Launch SINEFIX in Selected Clinical Sites in 2023

ALBSTADT, Germany – Inovedis GmbH, a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for SINEFIX™, a new implant system for the repair of rotator cuff tears.

In the United States, over 1 million rotator cuff surgeries per year are performed. A rotator cuff tear is a common cause of shoulder pain and disability, and surgery typically involves re-attaching the tendon to the head of the humerus (upper arm bone). The SINEFIX implant system allows refixation of the rotator cuff tendon to bone with a simplified surgical technique that has been optimized for minimally invasive surgery. The technique is easy and quick to learn for the surgeon and aims to significantly reduce time and cost of the procedure.

“Current clinical standards rely on anchoring the ruptured tendon onto its anatomical insertion zone, or ‘footprint,’ upon the humerus using a ‘knot and anchoring technique’. However, these techniques are complex, time-consuming, require an extensive range of instruments and are quite expensive. Moreover, they mainly focus on improving the mechanical fixation of the tendon-bone interface to the detriment of biological healing,” said Stefan Welte, MD, shoulder surgeon and inventor of SINEFIX.

Unlike the traditional surgery, the new technique shall both provide effective mechanical reinforcement of the fixed tendon and stimulate the patient’s intrinsic healing potential. SINEFIX is a simple staple implant, which creates a flat and even contact of tendon and bone. It distributes the shear stress uniformly and does not cause punctual pressure peaks, while also maintaining blood circulation and supporting the healing process.

The insertion of the implant is possible with a simple, easy-to-learn two-step technique: The base plate is positioned, and the fixation points are driven into the bone with a hammer and the appropriate SINEFIX instruments provided by Inovedis. No preliminary work is needed, and the device may be implanted using arthroscopic techniques or open reconstruction. This simplified technique is designed to reduce the risk of complications due to surgical errors and significantly shortens surgery time, contributing to time and cost savings in clinical surgeries.

“With FDA clearance we will now initiate a first mover application to generate real-world experience in the U.S. to evaluate the potential of the technology,” says Lukas Flöss, Founder and CEO. “We are looking forward to the launch of SINEFIX at the upcoming American Orthopaedic Society for Sports Medicine (AOSSM) annual meeting July 13-16th in Washington DC, followed by enrolling clinical sites into our limited market release to begin gathering experience around SINEFIX.”

About Inovedis

Inovedis GmbH is a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions. Since its founding in 2019, Inovedis has been developing SINEFIX™ to simplify rotator cuff tear surgery and improve patient outcomes. SINEFIX received FDA clearance in 2023.

SINEFIX is not approved for sale outside the U.S.

To learn more, visit our website and follow us on LinkedIn.

Lukas Flöss, Founder and CEO
Phone: +49 (0) 7432 – 13099 20