Model note · Cranial Drill
Medtronic Midas Rex MR8 high-speed drill system
The Midas Rex MR8 is a high-speed surgical drill platform used in neurosurgery, spine, ENT and other theatres to cut and shape bone and tissue, for example in craniotomy. It comes in electric versions powered by Medtronic's Integrated Power Console (IPC) and pneumatic versions, with reusable handpieces and attachments and single-use sterile dissecting tools, and navigated versions work with the StealthStation S8.
The model
Maker, model and type.
- Maker
- Medtronic Powered Surgical Solutions (Medtronic, Inc.)
- Model
- Medtronic Midas Rex MR8 high-speed drill system
- Device type
- Cranial Drill
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Power sources | Electric handpieces powered by the IPC, or pneumatic handpieces driven by air pressure | Source |
| System components | Electric and pneumatic handpieces, attachments, surgical dissecting tools and accessories; handpieces and attachments reusable and supplied non-sterile | Source |
| Dissecting tools | Single use, gamma sterilised, 5 year shelf life | Source |
| Tool overall length | 3 to 42 cm | Source |
| Tool head diameter | 0.5 to 25 mm | Source |
| Attachment types and length | Straight, angled, variable, double-lock, footed, telescoping, perforator, Jacobs chuck, J-Latch and metal cutting; 2 to 40 cm | Source |
| Indications | Cutting, drilling and sawing of bone, tissue and biomaterials in cranial and craniofacial, ENT, maxillofacial, orthopaedic, spinal, sternotomy and general surgery | Source |
| Standards | IEC 60601-1:2005 electrical safety and IEC 60601-1-2:2014 EMC for electric instruments | Source |
| Regulatory class | FDA Class II; product codes HBC, HBB, HSZ, ERL, HBE | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Refer to the MR8 instructions for use for contraindications, warnings and precautions; Medtronic states its product page does not replace them. Source
- Handpieces and attachments are supplied non-sterile and must be cleaned and sterilised before every use. Source
- Dissecting tools are single use only; do not reprocess them. Source
- Overheating is the most reported MAUDE problem for MR8, so watch for a hot handpiece or attachment during use and report it. Source
Sources
Where this note comes from.
- FDA 510(k) K163565 summary, MR8 Drill System
- FDA 510(k) K183515 summary, MR8 Drill System and ClearView Tools
- Medtronic Midas Rex MR8 product page (EMEA)
- openFDA MAUDE problem counts, Midas Rex MR8
- openFDA recalls, Midas Rex products since 2016
Not covered: The MR8 IFU and IPC console manual were not opened, so speed ranges, console error messages and the cleaning and lubrication procedure are not included; no FDA recall naming MR8 was found (Midas Rex recalls in the database concern the older Legend system and its tools).
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Cranial Drill