BETA
Lisle, Illinois-based manufacturer of single-use, battery-powered surgical drills for cranial access and spinal procedures.
Hubly Surgical develops and markets surgical drilling technology for neurosurgical care. Founded in 2019 and based in Lisle, Illinois, the company offers the Hubly Auto-Stop Drill and Cranial Access Kit for hospital use. The cordless drill combines automatic stopping, a tapered bit and visual force feedback.
The Hubly Electric Drill received FDA 510(k) clearance for adult cranial bone drilling in May 2023. A second clearance in November 2025 added drilling through the lamina during adult laminectomy and laminotomy procedures. These are two clearance decisions for the drill platform, rather than a count of individual indications.
Commercial development includes a company-announced $3 million seed round in July 2023 and a Vizient Innovative Technology contract announced in September 2025. Hubly reported more than 6,000 drills sold by that announcement; this is a dated company sales claim, rather than an independently audited count of procedures or customer hospitals.
Hubly’s H100 auto-stop cranial drill has two documented 510(k) decisions, K230619 and K250815. Current manufacturer material and device-distribution records support commercial availability; clearance remains specific to the labeled drill configurations and intended use. [10][11][4][12][13][16]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [18][19]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
Documented commercial product families.
Sterile, disposable, battery-powered drill with automatic stopping on bone breakthrough, a tapered stainless-steel bit and LED force feedback. Offered with the Hubly Cranial Access Kit for cranial access; the H100 also has a cleared spinal indication. [12][2][4][5][6][7][8][9]
FDA-clearedCompany offers the drill and Cranial Access Kit for sale in the United States.
Hubly announced the new spinal clearance and described supporting bench, usability and cadaver testing. The FDA summary states clinical testing was not performed for this submission. [14]
The FDA cleared K250815, adding drilling through the lamina during adult laminectomy and laminotomy procedures for H100. The decision date precedes the company announcement. [3]
Hubly announced an Innovative Technology contract for its Auto-Stop Drill + Cranial Access Kit. The announcement also reported over 6,000 drills sold. A purchasing contract does not establish sales to every Vizient client. [15]
Hubly reported 5,000 Auto-Stop Drills sold. This dated company-reported sales milestone does not establish a procedure count or a verified customer total. [13]
Hubly announced an oversubscribed $3 million seed round to support commercialization, development and post-market data collection. This is an announced round amount, not cumulative funding. [22]
The FDA cleared the Hubly Electric Drill (H100) under K230619 for adult cranial bone drilling. [1]
Accessed 10/29/2026