Adeor Medical AG · Class II · Cleared Mar 6, 2026
| K-number | K253772 |
| Device name | Velocity Alpha MR High Speed Surgical Drill System |
| Applicant | Adeor Medical AG |
| Product code | HBB |
| Device class | Class II |
| Decision date | Mar 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4370 |
The Velocity Alpha MR High Speed Surgical Drill System is a pneumatic-powered surgical motor drill system for neurosurgery. It performs trephination, incision, cutting, removal, shaping, and sawing of soft and hard tissue, bone, and biomaterials in or near magnetic fields of 3.0 Tesla or less. The system consists of a motor, motor hose, two attachments, and four cutting instruments.
The subject device is MR-conditional up to 3.0 Tesla, operates at maximum 80,000 rpm with 6–8 bar air pressure, uses compressed nitrogen or medical-grade compressed air, and includes four cutting instruments. The predicate device (Stryker Aria Pneumatic System) characteristics were not publicly available, making direct technological comparison limited.
ISO 10993-1 for biocompatibility evaluation; FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment' for MR-conditional validation. Testing included functional validation, sterilization validation, cleaning validation, packaging validation, lifetime testing, and cadaveric drill testing.
View the full FDA submission: accessdata.fda.gov