Blog

- ORTHOPEDICS

Onkos Surgical® Receives FDA 510(k) Clearance for ELEOS™ Proximal Tibia with NanoCept® Antibacterial Technology

PARSIPPANY, N.J., Oct. 21, 2025 /PRNewswire/ — Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, announced that it has recently received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ELEOS Proximal Tibia with NanoCept Antibacterial Technology. This marks the first 510(k) clearance for the NanoCept Antibacterial Technology since the original De Novo authorization was granted in April of 2024.

Read More »

Centinel Spine® Receives Two-Level FDA Approval for prodisc® C Vivo and prodisc® C SK Match-the-Disc™ Cervical Total Disc Replacement Devices

WEST CHESTER, Pa., Oct. 14, 2025 /PRNewswire/ — Centinel Spine®, LLC (“the Company”), the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for 2-level indications for the prodiscC Vivo and prodisc C SK Cervical TDR devices. Since receiving FDA approval for 1-level indications in July 2022, nearly 20,000 prodiscC Vivo and prodisc C SK spinal levels have been implanted in the U.S. by over 1,100 surgeons.

Read More »

Next-Generation AI-Driven SyncAR® Spine Receives FDA Clearance for Spine Surgery

CLEVELAND, Oct. 10, 2025 /PRNewswire/ — Surgical Theater, the leader in surgical XR visualization, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for SyncAR® Spine, the next-generation release of its spine platform. This clearance expands the system’s capabilities with advanced XR tools powered by AI algorithms. This brings patient MRI and CT directly into the operating room, aligning preoperative plans with intraoperative execution for greater clarity and control in spine surgery.

Read More »