Hubly Surgical Auto-Stop Drill Receives FDA 510(k) Clearance for Spinal Decompression Surgery: Laminectomy and Laminotomy

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.

The FDA's decision was supported by bench, usability, and cadaver testing conducted at UC San Diego Health, where Chief of Regional Neurosurgery and Hubly Drill user Dr. David Santiago-Dieppa said:

"The Hubly Drill for Neuro ICU has worked perfectly every time. I love that thing . . . I use the matchstick burr in my spine practice today. In our cadaver lab, the Hubly Drill felt safer for the dura and faster for the patient. Sign me up."

The single-use, cordless Hubly Auto-Stop Drill features SMART auto-stop that detects breakthrough and immediately stops rotation upon bone penetration. This proprietary mechanism is combined with mechanical plunge-prevention (tapered stainless-steel bit) to prevent forward movement of the drill upon this auto-stop and protect the patient from harm, as well as real-time visual force indication that aids user control. These design elements are intended to enhance safety, speed, and efficiency and streamline setup and workflow compared with today's standard of care.

"Today's clearance marks a pivotal step for Hubly's platform," said Casey Qadir, Founder & CEO of Hubly Surgical. "Our goal is to save and improve lives by giving surgeons intuitive tools that protect critical tissue every single time. With cranial and spinal indications now in hand, we can support neuro-spine teams across the board. One consistent, safe device experience across settings and use cases."

About Hubly Surgical

Hubly Surgical is a medical device company committed to advancing patient safety and improving outcomes through innovative surgical technologies. Its flagship product, the Hubly Auto-Stop Drill, incorporates safety features that can help reduce complications in cranial access and spinal decompression. For more information, visit hublysurgical.com.

SOURCE Hubly Surgical Inc.