# K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Powered Surgical Solutions
- Decided: May 15, 2017 after 103 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: 9 generations back to K862807 (1986). 62 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)], Medtronic Xomed, Inc. (2008) Summary page 5.
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery), Sodemsystems (2001) 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.
- K121264: Triton Electric High Torque Handpiece and Software Module, Medtronic Surgical Technologies (2012) Summary page 5.

## Cited in the summary but kept off the family tree
- K870157: Oscillating Saw/ Reciprocating Saw/ Drill-Reamer, Micro-Aire Surgical Instruments, Inc. (1987). Our reading of the summary gave K870157, FDA’s number for Oscillating Saw/ Reciprocating Saw/ Drill-Reamer (Micro-Aire Surgical Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Surgical Dissecting Tools”. Kept off the family tree. 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 Electric Drill System is a electrically operated surgical instrument system. The electric 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 Electric 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 lnterbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar lnterbody Fusion (ALIF) - Direct Lateral lnterbody Fusion (DLIF)

Source page: https://510kreport.com/device/K170312
Methodology: https://510kreport.com/methodology