Capitan Orthopedics, Inc. Announces Breakthrough Device Designation for its SupraSpacer™ Implant

GRAND RAPIDS, Mich., April 30, 2026 /PRNewswire/ -- Capitan Orthopedics, Inc. (https://capitanortho.com/) announced today that it has been granted Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its SupraSpacer^TM implant.

Today, over 2 million people a year are diagnosed with a rotator cuff injury and over 700,000+ undergo surgery to repair a primary rotator cuff tear. But there is a massive gap in the care continuum and for decades patients with irreparable rotator cuff tears have faced a frustrating reality: few options exist to restore range of motion and relieve pain. Traditional soft tissue procedures are not possible when the tendon is too damaged or retracted, and for most patients under age 60, a reverse shoulder replacement is not the best option. The SupraSpacer^TM implant is an innovative, long-term option designed to restore joint alignment and enable pain-free range of motion, all while preserving future surgical options.

Chance Leonard, CEO of Capitan Orthopedics, Inc., commented, "I am excited to announce that Capitan Orthopedics, Inc. has received Breakthrough Device Designation for its SupraSpacer™ implant technology. This is yet another milestone achievement for our team and this designation validates the significant unmet medical need."

R. Sean Churchill, MD, MBA, lead surgeon designer, stated, "Addressing irreparable rotator cuff tears with a biomechanical solution that significantly reduces or eliminates pain altogether and increases patient function is paramount. The SupraSpacer™ is a novel implant technology which provides surgeons with a simple, repeatable, and effective procedure that will have a positive impact on patient outcomes and surgical workflow. It is specifically designed to help maintain the humeral head centered in the joint, reduce the risk and advancement of shoulder arthritis, remove the painful abutment of the humeral head on the undersurface of the acromion, and allow for full impingement-free range of motion."

Mr. Leonard further noted, "Today is a special day. We continue to be encouraged by the strength of the unmet clinical need we are addressing and the progress we have made in delivering a solution that is both innovative and practical. With core development complete and a clear regulatory path ahead, we believe this is a compelling moment to accelerate forward."

About Capitan Orthopedics, Inc.

Capitan Orthopedics, Inc. is an innovator in the design of orthopedic implant products for shoulder surgery. The company has developed the SupraSpacer™ implant and procedure to successfully address the critical unmet need of irreparable rotator cuff tears in younger, active patients. This novel technology fills a distinct gap in the current care continuum and provides surgeons with a simple, reproducible solution that integrates smoothly into existing surgical workflows. The system is purpose-built for the ASC setting and includes sterile-packaged instruments and implants to support procedural efficiency.

Capitan Orthopedics, Inc. is backed by Genesis Innovation Group, Inc. (https://genesisinnovationgroup.com/), a leader in medical device development and commercialization and represents a compelling opportunity to bring a first-in-class solution to a large, underserved patient population. For investment information, please contact the company at 1-833-444-2468.

View original content to download multimedia:https://www.prnewswire.com/news-releases/capitan-orthopedics-inc-announces-breakthrough-device-designation-for-its-supraspacer-implant-302758266.html

SOURCE Capitan Orthopedics, Inc.