Catalyst OrthoScience Receives FDA Clearance for Expanded Indications of Catalyst Fracture Shoulder System
NAPLES, Fla., Dec. 4, 2025 – Catalyst OrthoScience Inc. (“Catalyst”), a private medical technology company redefining shoulder arthroplasty through simplified, surgeon-focused innovation, today announced that its Catalyst Fracture Shoulder system has received FDA 510(k) clearance for additional indications that now include anatomic (total or hemi) shoulder procedures, giving surgeons flexibility to treat complex proximal humeral fractures (PHFs) with a single, streamlined platform for both anatomic and reverse replacements. In anatomic indications, teh Catalyst Fracture System utilizes Catalyst’s ellipsoid head design, shown to better restore natural anatomy compared to customary spherical head designs on the market today.
“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,” said ephraim Akyuz, PhD, chief technology officer at Catalyst. “With these expanded indications, we’re equipping surgeons with even greater flexibility to achieve better patient outcomes, reinforcing catalyst’s role as a leader in next-generation shoulder solutions.”
The shoulder fracture market is estimated at over $250 million, and Catalyst has seen strong adoption of the catalyst Fracture System since its full commercial release in August 2025. with these expanded indications, Catalyst anticipates even stronger adoption of this system which also enables future conversion from anatomic to reverse without removing the fracture stem. This simplifies revision surgery, reduces risk, and saves valuable time in the operating room.
“Proximal humerus fractures are among the most complex cases in shoulder surgery, and past solutions often forced surgeons into comp