Catalyst OrthoScience has received U.S. Food and Drug Administration (FDA) 510(k) clearance for additional indications on its Catalyst fracture shoulder system.

The new indications now include anatomic (total or hemi) shoulder procedures—surgeons can now treat complex proximal humeral fractures (PHFs) with a single, streamlined platform for both anatomic and reverse replacements. In anatomic indications, the Catalyst fracture system uses the company’s ellipsoid head design, which was shown to better restore natural anatomy compared to spherical head designs on the market today.

Catalyst Ortho released the Catalyst fracture system in August 2025. With the expanded indications, the company expects stronger adoption of the system, which also allows future conversion from anatomic to reverse without removing the fracture stem. This simplifies revision surgery, according to the company, reduces risk, and saves valuable OR time.

Orthopedic surgeon Dr. E. Scott Paxton told the press that proximal humerus fractures are among the most complex cases in shoulder surgery, and past solutions often forced surgeons to compromise.

These expanded indications for the Catalyst Fracture System give surgeons additional confidence and tools to reconstruct the joint as intended, without trade-offs, and set a new standard for how we approach these complex fractures,” said Dr. Paxton.

The launch of dedicated Fracture Tuberosity Repair Kits supported the expanded indications. They’re designed to streamline intraoperative tuberosity management and enable surgeons to use their preferred techniques for secure, anatomic reconstruction.

“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, Ph.D., 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.”

In October, the company secured $15 million in equity and debt financing to advance its high-growth commercial and clinical programs, led by RC Capital, with participation from Mutual Capital Partners, Dr. Derace Schaffer, and Western Alliance Bank, Member FDIC.