Arcuro Medical Achieves FDA 510(k) Clearance for SuperBall RC System Enhancing Rotator Cuff Repairs

Arcuro Medical's Latest Innovation: The SuperBall-RC™ System

Arcuro Medical Ltd., a leader in the development of minimally invasive orthopedic solutions, has recently announced that it has received FDA 510(k) clearance for its SuperBall-RC™ product. This innovative system is specifically designed for rotator cuff repair, a common procedure where patients often face re-tear rates as high as 20-40%, particularly in those over the age of 50. Such statistics highlight the critical need for improved surgical solutions in this area.

The SuperBall-RC™ is built upon Arcuro's established SuperBall technology platform, which has demonstrated success in over 5,000 meniscus repair procedures. The technology effectively addresses the complexities associated with rotator cuff augmentation, particularly when using biologic or biosynthetic grafts. Traditional surgical techniques can be technically demanding, creating a gap that this new instrument aims to fill.

Dr. Philip Davidson, the Medical Director at Arcuro, has praised the SuperBall-RC™ for its ability to enable safe and straightforward fixation of augmentation grafts, noting, "The device has exceeded my expectations and offers a very attractive alternative to fixate augmentation patches and enhance healing." This statement reflects the hope and optimism surrounding the new system's potential impact on surgical outcomes.

Jamal Rushdy, Arcuro's CEO, expressed enthusiasm for this significant regulatory achievement, emphasizing the importance of this milestone for the company. He commended the efforts of the product development and regulatory teams, stating, "We are thrilled to have received this regulatory clearance, which will enable surgeons to improve rotator cuff repair outcomes for their patients." With the SuperBall-RC™ poised to enter a limited user release in the second quarter of 2025, there is a palpable sense of excitement regarding its imminent market debut.

The initial phase of release is a strategic move as Arcuro anticipates full launch in the latter half of 2025, ahead of schedule, thanks to the timely approval from the FDA. The company plans to showcase the SuperBall-RC™ further at prominent upcoming events, including the Canaccord Genuity Musculoskeletal Conference in San Diego and the LSI Emerging MedTech Summit in Dana Point.

Arcuro Medical, headquartered in Israel with operations in both Minneapolis, Minnesota and Naples, Florida, is backed by The Trendlines Group and has an experienced team with over 40 years in the medical device sector. This background equips them to continue innovating within the field of sports medicine, ultimately striving to enhance the quality of life for patients.

As they expand their distribution network to introduce the SuperBall technology to healthcare professionals globally, Arcuro remains committed to developing transformative solutions. For additional details about the SuperBall-RC™ and other innovations by Arcuro Medical, visit their official website at arcuromedical.com.

In summary, the FDA clearance for the SuperBall-RC™ marks a pivotal moment not just for Arcuro Medical but for orthopedic surgery as a whole. By answering the call for more effective and simpler surgical solutions to common problems, they lay the groundwork for better patient outcomes in rotator cuff repair surgeries.