Catalyst OrthoScience has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Archer patient-specific instrumentation (PSI).

Licensed in collaboration with 3D-Side, Archer PSI is a full suite of humeral and glenoid guides tailored to patient anatomy. According to the company, it allows surgeons to execute their 3D preoperative plans intraoperatively with more precision, consistency, and confidence.

Used with Archer 3D planning software, Archer PSI boosts pre-op planning accuracy and supports intra-op efficiency. It’s indicated for anatomic and reverse procedures so surgeons can personalized humeral and glenoid implant positioning.

“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.”

The company began a limited market release of Archer PSI with select surgeon partners, including using it in anatomic and reverse cases. Insights gathered during the limited release will guide final product optimization ahead of 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.”

In December, the company won FDA clearance for the indications of anatomic (total or hemi) shoulder procedures on its Catalyst fracture shoulder system.