Catalyst OrthoScience receives FDA 510(k) clearance of proximal humerus fracture system
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Key takeaways:
- Catalyst OrthoScience received FDA 510(k) clearance of the Catalyst shoulder fracture system.
- The system is designed for use in reverse shoulder arthroplasty for patients with proximal humerus fractures.
Catalyst OrthoScience announced FDA 510(k) clearance of the Catalyst shoulder fracture system for patients with proximal humerus fractures, according to a company press release.
“With the addition of the Catalyst fracture system, we now have a comprehensive portfolio that allows surgeons to help a broader range of patients,” Carl O’Connell, CEO of Catalyst, said in the release. “This product is key to our strategy and builds our leadership in the orthopedics market.”
The Catalyst fracture system is designed for use during reverse shoulder arthroplasty for patients with proximal humerus fractures, according to the release.
“The use of RSA for the treatment of [proximal humerus fractures] PHFs is steadily increasing,” Steven Goldberg, MD, founder and chief medical officer of Catalyst, said in the release. “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 proximal humerus fractures in an efficient and novel way.”
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