# K172907: ELAN 4 Air Motor System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Nov 9, 2018 after 410 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943589 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152960: ELAN 4 Motor System, Aesculap, Inc. (2016) Summary page 4.

## Recalls of this device
- Aug 18, 2025 · Class II · Z-0027-2026: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- Aug 18, 2025 · Class II · Z-0026-2026: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

## Indications for use
The ELAN 4 Air 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/K172907
Methodology: https://510kreport.com/methodology