- In March 2025, restor3d announced FDA 510(k) clearance for its Ossera AFX Ankle Fusion System. This breakthrough 3D-printed fusion system incorporates their proprietary TIDAL Technology for optimized osseointegration and biomechanical stability. They also highlighted their Kinos Total Ankle System, a fully personalized total ankle arthroplasty solution designed for precision and surgical efficiency, and the Ossera Wedge Family for corrective foot and ankle procedures, all featuring TIDAL Technology to eliminate graft failure concerns. These products are set for commercial availability in May 2025.
- In April 2025, Medline UNITE announced FDA 510(k) clearance for its REFLEX HYBRID Nitinol Implant System. This innovative system combines the dynamic compression of a nitinol staple with the stability of a locking plate. It's designed for specific procedures like MTP fusions and Lapidus procedures and allows surgeons to achieve intraoperative compression and adjustment, addressing gaps in the current market. Biomechanical testing has shown it provides statistically significant better load to failure and gapping at failure results compared to traditional titanium plate and screw constructs.
