May 2026 The U.S. FDA implemented the reclassification of certain non-invasive bone growth stimulators from Class III to Class II, subject to premarket notification and special controls, establishing a revised regulatory pathway for these bone-healing devices.
December 2025 Xtant Medical commercially launched nanOss Strata, its next-generation synthetic bone graft. The product is designed to mimic human bone structure, increase graft surface area, improve osteoconductivity, and stimulate cellular activity.
November 2025 Ventris Medical received U.S. FDA 510(k) clearance for its Backpack bone graft containment system, expanding technologies designed to support controlled placement and containment of bone graft material in orthopedic procedures.
November 2025 CGBIO received FDA investigational device exemption approval for Novosis Putty, advancing the rhBMP-2-based bone graft solution for clinical evaluation in spinal fusion applications.