Catalyst OrthoScience’s Catalyst Fracture Shoulder System 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 with a single, streamlined platform for both anatomic and reverse replacements.
In anatomic indications, Catalyst Fracture utilizes Catalyst’s ellipsoid head design, shown to better restore natural anatomy compared to traditional spherical head designs.
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.
“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, CTO at Catalyst. “With these expanded indications, we’re equipping surgeons with even greater flexibility to achieve better patient outcomes.”
Catalyst OrthoScience's Catalyst Fracture Shoulder System 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 with a single, streamlined platform for both anatomic and reverse replacements.
In anatomic...
Catalyst OrthoScience’s Catalyst Fracture Shoulder System 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 with a single, streamlined platform for both anatomic and reverse replacements.
In anatomic indications, Catalyst Fracture utilizes Catalyst’s ellipsoid head design, shown to better restore natural anatomy compared to traditional spherical head designs.
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.
“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, CTO at Catalyst. “With these expanded indications, we’re equipping surgeons with even greater flexibility to achieve better patient outcomes.”
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