# K130755: Hicut Highspeed Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Adeor Medical AG
- Decided: Jun 27, 2014 after 465 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K862807 (1986). 36 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113476: Anspach Dissection Tools, The Anspach Effort, Inc. (2011) Summary page 2.
- K922299: Zeppelin Motor Drill System, Von Zeppelin Chirurgische Instrumente GmbH (1992) Summary page 2.
- K013091: ZMM 2000 Zeppelin Millennium Motordrill System, Von Zeppelin GmbH (2002) Summary page 2.
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)], Medtronic Xomed, Inc. (2008) Summary page 2.

## Most influential descendants
- K232684: Surgify Halo (2023), 3 descendants of its own
- K250380: Surgify Halo   (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (2025), 2 descendants of its own
- K251433: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (2025), 1 descendant of its own
- K253627: Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) (2026), 0 descendants of its own

## Indications for use
HiCutTm Highspeed Instruments are surgical burs indicated for trephination, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and biomnaterials in Orthopedic Surgery, Neurological and Spinal Surgery, ENT Surgery, Plastic and Maxillofacial Surgery, Arthroscopy, Stemnotomy and General Surgery.

Source page: https://510kreport.com/device/K130755
Methodology: https://510kreport.com/methodology