# K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Powered Surgical Solutions
- Decided: Mar 23, 2017 after 129 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020069 (2002). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870157: Oscillating Saw/ Reciprocating Saw/ Drill-Reamer, Micro-Aire Surgical Instruments, Inc. (1987) Summary page 5.
- K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System, Medtronic Midas Rex (2002) Summary page 5.
- K072315: Midas Rex Curved Bur, Medtronic Powered Surgical Solutions (2007) Summary page 5.
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700, Medtronic Powered Surgical Solutions (2009) Summary page 5.

## Most influential descendants
- K191597: Stealth Autoguide System, Midas Rex Legend Depth Stop System (2019), 4 descendants of its own
- K183515: MR8 Drill System, Midas Rex MR8 ClearView Tools (2019), 4 descendants of its own
- K183644: Stealth-Midas MR8 System (2019), 3 descendants of its own
- K210989: Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System (2021), 2 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own

## Indications for use
The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Pneumatic Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and 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 lnterbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar lnterbody Fusion (ALIF) - Direct Lateral lnterbody Fusion (DLIF)

Source page: https://510kreport.com/device/K163182
Methodology: https://510kreport.com/methodology