# K050519: Advanced Turbo Drive System

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corp.
- Decided: May 17, 2005 after 77 days
- Product code: GEY (Motor, Surgical Instrument, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4820
- 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: 1 generation back to K002523 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002523: Advantage Drive System, Linvatec Corp. (2000) Summary page 5.

## Most influential descendants
- K130497: D4000 Drive System; D4000A Drive System with Irrigation (2013), 0 descendants of its own

## Recalls of this device
- Jan 24, 2013 · Class III · Z-0916-2013: The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third 
- Jan 24, 2013 · Class III · Z-0917-2013: The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third 

## Indications for use
The Advantage® Turbo Drive 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, Neurosurgical, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive and Spinal surgical procedures.

Source page: https://510kreport.com/device/K050519
Methodology: https://510kreport.com/methodology