LISLE, Ill., Nov. 12, 2025 /PRNewswire/ — Hubly Surgical today announced FDA 510(k) clearance expanding Hubly Auto-Stop Drill indications to include spinal decompression procedures. To date, many thousands of neurosurgical patient lives have been saved using Hubly Auto-Stop Drills; the device’s SMART auto-stop halts rotation and prevents forward plunge at the instant of skull penetration, preventing over-drilling into patients’ brains. The new clearance expands use to laminectomy and laminotomy for spinal decompression to drill through the vertebral lamina and protect patients from damage to the spinal cord.

DALLAS, Nov. 6, 2025 /PRNewswire/ — Dallas-based MedCAD has been awarded 510(k) FDA clearance for its AccuStride fixation plates, part of a patient-specific solution available to surgeons as a complete foot and ankle (F&A) system. The company received 510(k) FDA clearance for its foot and ankle guides and planning system in March 2025. The AccuStride implant and surgical guide system coupled with the company’s proprietary planning software will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure.

Zimmer Biomet (NYSE: ZBH)+
announced today that it received FDA breakthrough device designation for its iodine-treated total hip replacement system.

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.

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.