Catalyst Ortho’s Shoulder Fracture System Wins FDA Nod, Has 1st Cases

Catalyst OrthoSciences has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for its Catalyst fracture shoulder system, a reverse for fracture arthroplasty system to treat proximal humeral fractures (PHFs). The company also announced the first surgeries have been successfully performed using the system.
 
The Catalyst fracture system for RSA includes tuberosity-specific fossa designed to maximize tuberosity contact and healing to a porous surface. The company’s patented tuberosity retention rails are designed to further restrict tuberosity post-operatively.
 
The system touts uncemented, secure press-fit diaphyseal fixation and strong rotational stability, the company said, with cemented options as well. It’s compatible with glenospheres and baseplates in standard, augmented, and lateralized configurations.
 
“The use of reverse shoulder arthroplasty (RSA) for the treatment of PHFs is steadily increasing,” said Dr. Steven Goldberg, chief medical officer of Catalyst. “One of the most critical challenges in treating PHFs is ensuring tuberosity fixation and healing. Traditional reverse implants are designed to treat shoulder arthritis, but fractures are a completely different problem with different objectives for the surgeon. Catalyst has engineered a solution that specifically addresses the complexities of PHFs in an efficient and novel way.”
 
One of the first cases using the new fracture system was successfully performed by Dr. Matthew D. Budge from Salem, OR, who commented on the experience: “The unique design of the proximal body greatly simplified the usual difficulties encountered with tuberosity management. In addition, the ability to get excellent diaphyseal fixation of the implant without cement or screws greatly improved the efficiency of the case. Overall, I was very impressed.”
 
Catalyst said it will complete a limited user release to gather more data on the system’s performance ahead of broader commercial release next year.
 
“With the addition of the Catalyst Fracture System, we now have a comprehensive portfolio that allows surgeons to help a broader range of patients,” said Carl O’Connell, CEO of Catalyst. “This product is key to our strategy and builds our leadership in the orthopedics market.”
 
Last month, the company celebrated over 10,000 total shoulder arthroplasty procedures and secured $20 million in equity and venture debt financing.