# K183515: MR8 Drill System, Midas Rex MR8 ClearView Tools

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Powered Surgical Solutions
- Decided: May 12, 2019 after 145 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K862807 (1986). 67 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163565: MR8 Drill System, Medtronic Powered Surgical Solutions (2017) Summary page 6.
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools, Medtronic Powered Surgical Solutions (2017) Summary page 6.
- K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories, Medtronic Powered Surgical Solutions (2017) Summary page 6.

## Most influential descendants
- K183644: Stealth-Midas MR8 System (2019), 3 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K240568: DuraPro™ Oscillating System (2024), 0 descendants of its own
- K202552: Midas Rex Attachments and Dissecting Tools (2020), 0 descendants of its own

## Indications for use
The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures. Additionally, the MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: • Lumbar Microdiscectomy • Lumbar Stenosis Decompression • Posterior Lumbar Interbody Fusion (PLIF) • Transforaminal Lumbar Interbody Fusion (TLIF) • Anterior Lumbar Interbody Fusion (ALIF) • Direct Lateral Interbody Fusion (DLIF) The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User’s Guides for the Indications of Use.

Source page: https://510kreport.com/device/K183515
Methodology: https://510kreport.com/methodology