restor3d Gains FDA 510(k) for Patient Specific Resection Guides

restor3d was granted FDA 510(k) clearance to market the Axiom PSR (Patient Specific Resection) System for use with the company’s Kinos Axiom Total Ankle. The Axiom PSR is additively manufactured from titanium alloy, reportedly making it the first all-metal, patient-specific instrument system cleared for use with an ankle replacement system.

Initial launch will commence this month, with full launch to follow in June.

Axiom PSR is designed to consistently deliver precision, accuracy and efficiency for total ankle procedures. The 3D-printed all-metal resection guides ensure ideal anatomic fit and exact placement of the pre-planned cut required to place the Kinos Axiom Total Ankle System Implants. The system’s streamlined design features are focused to reduce operative time during total ankle surgeries.

Axiom PSR guides incorporate a proprietary surface topography to ensure added stability at the bone contact interface. Additional features of the all-metal resection guides include integrated radiographic markers for fluoroscopic visualization and a limited footprint, which reduces soft tissue disruption.

Integrating TIDAL Technology’s interconnected porosity, the Axiom PSR System is the latest addition to restor3d’s lower extremity portfolio, which features the Kinos Axiom Total Ankle System, TIDAL Osteotomy Wedge Systems and MTP Hemiarthroplasty System, and the mobile companion App for the r3id Personalized Surgery platform.

Source: restor3d