Capitan Ortho Earns FDA Breakthrough Nod for SupraSpacer Implant

Capitan Orthopedics has been awarded breakthrough designation from the U.S. Food and Drug Administration (FDA) for its SupraSpacer implant.

Over two million people are diagnosed with a rotator cuff injury annually and more than 700,000 have surgery to repair a primary rotator cuff tear. However, the company cited a gap in the care continuum that patients with irreparable rotator cuff treat have few options to restore range of motion and relieve pain. Traditional soft tissue procedures aren’t possible when the tendon is too damaged or retracted.

For most patients under 60, a reverse shoulder replacement isn’t the best option. The SupraSpacer implant is a long-term option engineered to restore joint alignment and allow pain-free range of motion, while preserving future surgical options.

“I am excited to announce that Capitan Orthopedics, Inc. has received Breakthrough Device Designation for its SupraSpacer implant technology,” said Capitan Orthopedics  This is yet another milestone achievement for our team and this designation validates the significant unmet medical need.”

The SupraSpacer system is purpose-built for the ambulatory surgery center (ASC) setting and includes sterile, pre-packaged instruments and implants to support procedural efficiency.

“Addressing irreparable rotator cuff tears with a biomechanical solution that significantly reduces or eliminates pain altogether and increases patient function is paramount,” said lead surgeon designer R. Sean Churchill, MD, MBA. “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.”