Archer PSI System

The Archer PSI System is a patient-specific surgical instrument made from polyamide using additive manufacturing. It guides physicians in positioning shoulder replacement components and directing bone cuts during total shoulder arthroplasty, and is designed from pre-operative CT imaging and surgical planning validated through the Archer 3D Targeting platform.

Both the subject device and predicate are polyamide instruments manufactured additively based on surgeon-validated pre-operative planning, compatible with specific shoulder implant components. The key difference is that the anatomic humeral component cut slot characteristics differ between systems due to geometry differences in the compatible humeral components.

Not stated in this summary.

The Archer PSI System shares the same intended use as the predicate (MyShoulder Placement Guides K190738): both assist with instrumentation positioning during total shoulder arthroplasty via deltopectoral approach for anatomic and reverse configurations. Both employ polyamide with additive manufacturing based on surgeon-validated pre-operative planning. Nonclinical testing (biocompatibility, sterilization validation, mechanical integrity, debris generation) and cadaveric testing comparing manual versus PSI techniques for both anatomic and reverse procedures demonstrated substantial equivalence in performance and safety despite minor design variations in humeral component geometry.