Medtech company Catalyst OrthoScience has received FDA 510(k) clearance for additional indications for its Catalyst Fracture Shoulder System.
The new indications include anatomic shoulder procedures, allowing surgeons to treat complex proximal humeral fractures with a single platform for anatomic and reverse replacements, according to a Dec. 3 news release from the company.
In anatomic indications, the system uses an ellipsoid head design compared to traditional spherical head designs.
To support the expanded indications, Catalyst has launched fracture tuberosity repair kits to streamline intraoperative tuberosity management, the release said.
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