# K152960: ELAN 4 Motor System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 22, 2016 after 289 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: 2 generations back to K943589 (1994). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053526: Microspeed Uni Motor System, Aesculap, Inc. (2006) Summary page 4.

## Most influential descendants
- K203739: ELAN 4 Electro Motor System (2021), 0 descendants of its own
- K191479: Velocity Alpha Highspeed Surgical Drill System (2021), 0 descendants of its own
- K172907: ELAN 4 Air Motor System (2018), 0 descendants of its own

## Indications for use
The ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Source page: https://510kreport.com/device/K152960
Methodology: https://510kreport.com/methodology