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# FDA Clears restor3D 510(k) for Ankle Device
- URL: https://www.fdaweb.com/fda-clears-restor3d-510-k-for-ankle-device/
- Published: 2023-04-06T12:00:00.000Z
- Updated: 2026-09-14T18:24:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154152

FDA has cleared a restor3d 510(k) for the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The 3-D manufactured patient-specific resection device is made from titanium alloy, and its streamlined features are designed to sit on the bone and offer greater saw control compared to historical polymer patient-specific instruments, the company says. Additional benefits of the all-metal resection guides include integrated radiographic markers for fluoroscopic visualization and a limited footprint which reduces soft tissue disruption, it says.