Catalyst OrthoScience Receives FDA 510(k) Clearance for Expanded Indications of the Fracture Shoulder System

Audio By Carbonatix

NAPLES, Fla.--(BUSINESS WIRE)--Dec 3, 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, the Catalyst Fracture System utilizes Catalyst’s ellipsoid head design, shown to better restore natural anatomy compared to traditional 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 compromises,” said Dr. E. Scott Paxton, orthopedic surgeon. “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.”

Supporting these expanded indications is the launch of dedicated Fracture Tuberosity Repair Kits, designed to streamline intraoperative tuberosity management and enable surgeons to use their preferred techniques for secure, anatomic reconstruction. Together, these advancements expand treatment options, simplify complex procedures, and continue to set new standards in orthopedic care.

About Catalyst OrthoScience Inc.

Catalyst OrthoScience, founded in 2014 by orthopedic surgeon Dr. Steven Goldberg and based in Naples, Fla., is redefining shoulder replacement surgery. With a focus on less invasive techniques, fewer complications, and a more natural-feeling shoulder, Catalyst is breaking away from traditional approaches. Our total shoulder systems are engineered for precision and efficiency – preserving bone and soft tissue while enabling delivery of consistent, reproducible results. With a growing portfolio of issued and pending patents, Catalyst technology is available across the U.S. Learn more at www.catalystortho.com and connect with us on LinkedIn.

View source version on businesswire.com:https://www.businesswire.com/news/home/20251203120298/en/

CONTACT: Nicole Nelson

Media Relations

(239) 325-9976

KEYWORD: FLORIDA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: MEDICAL SUPPLIES SURGERY GENERAL HEALTH HEALTH FDA MEDICAL DEVICES HEALTH TECHNOLOGY OTHER HEALTH

SOURCE: Catalyst OrthoScience Inc.

Copyright Business Wire 2025.

PUB: 12/03/2025 10:00 AM/DISC: 12/03/2025 10:01 AM

http://www.businesswire.com/news/home/20251203120298/en