# K240340: Surgical Drive System (Model: ES70, ES90, E8)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Jinme Medical Technology Co., Ltd.
- Decided: Jul 18, 2024 after 164 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- 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 K931783 (1993). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213221: AMADEO, M-UK1015 (incl. attachments and accessories), W&H Dentalwerk Buermoss GmbH (2022) Summary page 5.

## Indications for use
The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, cutting, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery

Source page: https://510kreport.com/device/K240340
Methodology: https://510kreport.com/methodology