Restor3D
This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.
Inclusion Criteria: * ≥22 Years of Age * Scheduled to receive TTR implant for one of the following indications: * Avascular necrosis of the talus * Avascular necrosis of the talus in addition to talar collapse, cysts or non-union * Large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments * Nonunion following talar fracture or talar extrusion, unresponsive to more conservative treatments * Have not had a prior Total Talus Replacement device implanted * Not planning to receive bilateral Tota…
The restor3d patient-specific TTR Implant and Instrumentation System is designed to replace a native talus bone that has been affected by a disease state or injury. The implant is an additively manufactured Cobalt Chromium alloy (ASTM F3213) construct produced by laser powder bed fusion. The data-driven design of the implant enables the patient to salvage their joint while maintaining ankle range of motion, reducing pain and improving physical function.
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