Catalyst Receives FDA 510(k) Clearance for its Convertible Stemmed Total Shoulder Arthroplasty System
Catalyst is first-to-market with a fully convertible system that features an ellipsoid anatomic head
February 9, 2023
NAPLES, Fla.–(BUSINESS WIRE)–Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid anatomic head. 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 expects to begin the limited U.S. release in the second quarter of 2023 followed by a larger commercial launch later in 2023.
“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,” said Carl O’Connell, CEO and president of Catalyst. “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.”
In addition to its fully convertible stemmed total shoulder arthroplasty system, Catalyst offers:
- CSR Total Shoulder System
- R1 Reverse Shoulder System
- 3D Targeting Preoperative Shoulder Replacement Planning Software
“Catalyst now offers a comprehensive range of TSA solutions, including an anatomic stemless implant, a modernized reverse and an anatomic stemmed implant that can be converted to a reverse,” said Dr. Steven Goldberg, chief medical officer of Catalyst. “Our fully convertible system is the first to feature an ellipsoid anatomic head in a stemmed option, and it shares the design philosophy of the Catalyst CSRTM Anatomic Stemless System which has been shown in multiple peer reviewed clinical studies to provide excellent clinical outcomes. The stem design of the system features an inlay design with an anatomic neck shaft angle combined with a focus on a streamlined technique for efficiencies in the operating room. We look forward to introducing our fully convertible stemmed total shoulder arthroplasty system to the marketplace and working with surgeons and patients to improve shoulder replacement outcomes.”
About Catalyst OrthoScience Inc.
Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D., who saw the need to make shoulder replacement surgery less invasive, reduce complications and give patients a more natural-feeling shoulder after surgery. Catalyst OrthoScience is disrupting the usual approach to shoulder replacement surgery. Our CSRTM Total Shoulder System is unique, offering precision and accuracy in shoulder restoration while preserving the patient’s bone and soft tissue. The R1 Reverse Shoulder System is a single-tray arthroplasty system that offers surgeon-targeted implant positioning, a streamlined and versatile system and bone sparing implants. Catalyst OrthoScience has a growing portfolio of patents and pending patents on its distinctive surgical offerings. Headquartered in Naples, Fla., Catalyst products are available across the U.S. For more information, please visit www.catalystortho.com.
David Sharp, VP of Global Marketing