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Short answer: “Midas Rex” is a Medtronic brand name for high-speed pneumatic (air-powered) surgical drills used to cut bone. FDA does not classify products by brand. The generic device is “motor, drill, pneumatic” (product code HBB), regulated under 21 CFR 882.4370 as a Class II device. This page is general product and regulatory information, not medical advice.
What “Midas Rex” means: a brand, not a device category
Searchers use “Midas Rex drill” the way people say “Band-Aid” or “Kleenex”: as a shorthand for a whole kind of tool. Medtronic markets its Midas Rex MR8 as a high-speed pneumatic drill for bone cutting in surgery. That is one manufacturer’s product line. Regulators, procurement catalogs and filings describe the category by its generic name, so for supply or compliance work the useful terms are high-speed pneumatic neurosurgical drill, pneumatic cranial drill motor and motor, drill, pneumatic.
Definition and scope under 21 CFR 882.4370
The Code of Federal Regulations titles section 882.4370 “Pneumatic cranial drill motor.” It identifies the device as “a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient’s skull,” and classifies it as Class II (performance standards). The section sits in Part 882, Neurological Devices, Subpart E, Neurological Surgical Devices.
Two points follow from that wording. First, the regulation describes the power source: the motor that is driven by compressed gas. Second, the cutting tools and bits are described as removable, so they are a separate part of the system rather than the thing being classified in this section.
How the drill is used in practice
A pneumatic drill converts a compressed-gas supply into rotation at a handpiece, which holds a removable bit or attachment. The surgical technique itself, including bit selection and operating settings, belongs in the manufacturer’s instructions for use and in clinical training; this page deliberately does not describe procedure steps.
Types and related classifications
The FDA product classification record for code HBB and the neighboring powered cranial-drill regulation describe two different things. The table compares only what those two regulatory texts state.
| Feature | Pneumatic cranial drill motor (882.4370) | Powered compound cranial drills, burrs, trephines (882.4305) |
|---|---|---|
| What the regulation describes | A pneumatically operated power source used with removable rotating cutting tools or drill bits on a patient’s skull | Bone cutting and drilling instruments used on a patient’s skull, plus accessories |
| Clutch mechanism stated in the identification text | Not mentioned | Yes: a clutch disengages the tip after penetrating the skull to prevent plunging into the brain |
| Class | Class II (performance standards) | Class II (performance standards) |
For related instruments, see the CASRAI guides on neurosurgical instruments and their FDA classes, the trephine and the oscillating saw.
Where it matters for labs, clinics and supply decisions: a regulatory facts checklist
The FDA Product Classification database record for “motor, drill, pneumatic” (code HBB) lists the following. Use it as a checklist when reading a product listing or a filing.
- Device name and code: motor, drill, pneumatic; product code HBB; regulation number 882.4370; medical specialty Neurology.
- Device class: 2.
- GMP exempt: No. The record does not grant the exemption some lower-risk device types have.
- Summary malfunction reporting: Eligible. For how device problem reports work, see Medical Device Reporting (MDR).
- Third-party review: Eligible for the 510(k) Third Party Review Program.
- Implanted or life-sustaining: No for both.
Specifications, compatible attachments and safety information come from the manufacturer’s instructions for use, not from the classification record. The class and product code come from FDA, not from the brand page. The statutory background for device classes is in Medical Device Amendments of 1976.
Common misunderstandings
Is “Midas Rex” the name of the device type?
No. It is a brand. The FDA device type is “motor, drill, pneumatic,” and the regulation describes the generic device type regardless of brand.
Is a pneumatic drill the same as a powered compound cranial drill?
Not in the regulations. Section 882.4370 covers the pneumatic motor; section 882.4305 describes compound cranial drills, burrs and trephines that include a clutch mechanism.
Does Class II mean no special oversight?
No. The regulation states “Class II (performance standards)”, and the FDA record above shows the device is not GMP exempt.
FAQ
What is a Midas Rex drill?
A high-speed pneumatic surgical drill sold under a Medtronic brand and used to cut bone in surgery.
What is the FDA regulation for it?
21 CFR 882.4370, “Pneumatic cranial drill motor,” Class II, product code HBB.
Can this page tell me how to operate one?
No. Operation, bit selection and settings are clinical and manufacturer-instruction matters and are outside this page.
Sources
- 21 CFR 882.4370, Pneumatic cranial drill motor, via the Cornell Legal Information Institute e-CFR text, checked 2026-10-30.
- 21 CFR 882.4305, Powered compound cranial drills, burrs, trephines, and their accessories, via the Cornell Legal Information Institute e-CFR text, checked 2026-10-30.
- FDA Product Classification database, product code HBB, motor, drill, pneumatic, checked 2026-10-30.
- Medtronic, Midas Rex MR8 product page, checked 2026-10-30.
