Catalyst OrthoScience Gains FDA Clearance to Expand Use of Fracture Shoulder System
Catalyst OrthoScience has secured FDA 510(k) clearance to expand the indications of its Catalyst Fracture Shoulder System, allowing its use in anatomic total and hemi shoulder procedures. The update enables surgeons to manage complex proximal humeral fractures with one platform designed for both anatomic and reverse shoulder replacements. For anatomic use, the system incorporates the company’s ellipsoid head design, which aims to more closely restore natural joint geometry than traditional spherical options.
Ephraim Akyuz, PhD, chief technology officer at Catalyst, said the clearance represents both progress and purpose. “Achieving our fourth 510(k) clearance in three years is more than a regulatory milestone – it reflects the momentum and intentional investment behind our innovation strategy,” he said. “With these expanded indications, we’re equipping surgeons with even greater flexibility to achieve better patient outcomes.”
Catalyst reports strong adoption of the system since its commercial launch in August 2025. The expanded indications are expected to support further uptake, particularly because the design allows surgeons to convert from an anatomic to a reverse configuration without removing the fracture stem. The company notes that this approach may simplify revision procedures and reduce time in the operating room.
Orthopedic surgeon Dr. E. Scott Paxton said the broadened indications may help address longstanding challenges in shoulder fracture care. “Proximal humerus fractures are among the most complex cases in shoulder surgery, and past solutions often forced surgeons into compromises,” he said. “These expanded indications for the Catalyst Fracture System give surgeons additional confidence and tools to reconstruct the joint as intended, without trade-offs.”
Catalyst is also introducing dedicated Fracture Tuberosity Repair Kits to support the expanded indications. The kits are designed to streamline tuberosity management using a range of established surgical techniques. Together, the updates aim to expand treatment options and simplify procedures for surgeons treating these difficult fractures.
