Catalyst OrthoScience Inc. has 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,” a news release states.
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, Ph.D., 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.”
