Hubly Receives FDA 510(k)

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

November 12, 2025
8:28 pm

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.

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

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