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

New patient-specific solution expands Catalyst’s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy

NAPLES, Fla.--(BUSINESS WIRE)--Catalyst OrthoScience Inc. (“Catalyst”), a private medical technology company redefining shoulder arthroplasty through simplified, surgeon-focused innovation, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Archer® Patient-Specific Instrumentation (PSI). Licensed in partnership with 3D-Side, Archer PSI is a full suite of humeral and glenoid guides tailored to the patient’s anatomy that allow orthopedic surgeons to execute their 3D preoperative plans intraoperatively with greater precision, consistency, and confidence. Catalyst is one of the only companies to offer patient-specific guides for both the glenoid and humerus.

Used in combination with the Archer® 3D Planning Software, Archer PSI enhances preoperative planning accuracy and supports intraoperative efficiency. Archer PSI is indicated for anatomic and reverse procedures, enabling surgeons to personalize humeral and glenoid implant positioning while maintaining a streamlined surgical workflow.

“As the demand for enabling technologies continues to build, the Archer PSI system is yet another milestone in our commitment to delivering meaningful clinical and operational value to surgeons,” said Ephraim Akyuz, PhD, chief technology officer at Catalyst. “The addition of PSI to the Archer 3D planning system allows surgeons to now execute more accurately to their pre-operative plans while reducing the number of procedural steps and saving valuable operative time.”

Catalyst has initiated a limited market release (LMR) of Archer PSI with select surgeon partners, including use of Archer PSI in anatomic and reverse cases. Insights gathered during LMR will help guide final product optimization ahead of a broader commercial launch.

“Archer PSI integrates seamlessly into my surgical workflow and minimizes the risk of improper implant positioning,” said Dr. Matthew Kippe, a participating LMR surgeon/one of the Archer design surgeons. “The ability to plan cases in advance and execute with patient-specific guides, tailored to each person’s anatomy is extremely beneficial, especially in complex anatomy, and I look forward to contributing feedback as Catalyst prepares for full commercial release.”

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.

About 3D-Side S.A.

3D-Side is a Belgian medtech company founded in 2015, and offers customizable software and additive manufacturing technology to assist with complex bone surgery. From images to 3D printing, the company offers advanced tools for planning, team communication, and manufacturing of patient specific medical devices. For more information, visit www.3d-side.com.

Nicole Nelson
Media Relations
(239) 325-9976