510(k) Clearance for Shoulder System With Ellipsoid Anatomic Head

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a fully convertible stemmed total shoulder arthroplasty system with an ellipsoid anatomic head.

The shoulder system, according to the FDA summary document, is indicated for “use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.”

The shoulder system is “indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.” It is “intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.” The conditions include the following: osteoarthritis, avascular necrosis, rheumatoid arthritis, post-traumatic arthritis, and correction of functional deformity.

The system is also a “reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction” due to a number of conditions. The conditions include the following: “severe arthropathy with a grossly deficient rotator cuff; previously failed joint replacement with a grossly deficient rotator cuff; fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; bone defect in proximal humerus; non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; inflammatory arthritis including rheumatoid arthritis; and correction of functional deformity.”

In order to qualify for 510(k) clearance, the device must be substantially equivalent to a predicate device. The shoulder system is substantially equivalent to the AltiVate™ Shoulder System in regard to “intended use and indications, materials, size ranges, and design intent.”

According to the company’s press release, this is the “market’s first stemmed arthroplasty system featuring an ellipsoid humeral head, which allows for more accurate restoration of the natural joint kinematics compared to spherical head designs.”

Catalyst OrthoScience, Inc. submitted the Catalyst EA Convertible Stemmed Shoulder for FDA 510(k) clearance. Catalyst is a Naples, Florida based orthopedics company focused on shoulder replacement surgery. It plans to have a limited U.S. release of the shoulder system in the second quarter of 2023. It is anticipated that a larger commercial launch will occur later in the year.

Catalyst CEO and President Carl O’Connell said, “The addition of the fully convertible stemmed option allows Catalyst to offer a broader portfolio of arthroplasty options to shoulder surgeons and distribution partners across the market.”

O’Connell continued, “Catalyst OrthoScience is now positioned as the only company to offer anatomically shaped non-spherical heads in both stemmed and stemless solutions. Regardless of surgeon or patient need, Catalyst offers an innovative and differentiated clinical solution, creating implants that are purposefully designed to be better.”