MedTech Intelligence

Catalyst OrthoScience Gets FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty

Catalyst OrthoScience announced FDA 510(k) clearance for its Archer® Patient‑Specific Instrumentation (PSI), a suite of humeral and glenoid guides designed to translate 3D pre‑operative plans into the operating room. The system pairs with Archer® 3D Planning Software, supporting both anatomic and reverse shoulder arthroplasty. Catalyst has begun a limited market release with select surgeon partners to collect real‑world data before a broader launch. The company positions itself as one of the few providers offering patient‑specific guides for both glenoid and humerus components.