# K130497: D4000 Drive System; D4000A Drive System with Irrigation

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corporation D/B/A Conmed Linvatec
- Decided: Mar 29, 2013 after 31 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 K002523 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050519: Advanced Turbo Drive System, Linvatec Corp. (2005) Summary page 1.

## Indications for use
The D4000/D4000A System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.

Source page: https://510kreport.com/device/K130497
Methodology: https://510kreport.com/methodology