FDA Clears Catalyst’s Fracture Shoulder System for Broader Surgical Use
Catalyst OrthoScience Receives FDA 510(k) Clearance for Expanded Indications of the 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, 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.
Catalyst OrthoScience Inc. has secured its fourth FDA 510(k) clearance in three years. This latest approval expands the use of its Catalyst Fracture Shoulder System for treating complex shoulder pain. The company, based in Naples, Florida, aims to improve patient outcomes with less invasive techniques.
Founded in 2014 by orthopaedic surgeon Dr. Steven Goldberg, Catalyst specialises in shoulder replacement innovations. The newly expanded indications now cover anatomic (total or hemi) shoulder procedures, allowing surgeons to address proximal humeral fractures (PHFs) with a single system. This flexibility means the same platform can handle both anatomic and reverse replacements.
The expanded clearance allows surgeons to treat a wider range of shoulder pain with a single, adaptable system. This development aligns with Catalyst’s goal of reducing complications and offering a more natural-feeling shoulder replacement. The company continues to build on its track record of regulatory approvals and surgical advancements.
