Naples, Fla.-based Catalyst OrthoSciences received FDA 501(k) clearance for its Catalyst Fracture Shoulder System, according to an Oct. 15 news release from the company.
Here are five things to know:
1. The system is a reverse for fracture arthroplasty system to treat proximal humeral fractures.
2. In addition to the FDA approval, the first surgeries using the system have been completed.
3. The system is designed to improve tuberosity fixation and healing.
4. The company plans for a larger commercial release of the system in 2025.
5. Catalyst OrthoSciences raised $20 million in financing in September.