510(k) · Cleared
Recalled · Class III · 2013Advanced Turbo Drive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · GEY Motor, Surgical Instrument, Ac-Powered
Cleared on May 17, 2005 as substantially equivalent to K002523 (Linvatec Corp., 2000) after a 77-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 17, 2005
- Review
- 77 days
- Class
- Class I
- Product code
- GEY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002523 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K130497D4000 Drive System; D4000A Drive System with IrrigationLinvatec Corporation D/B/A Conmed Linvatec · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002523 | Advantage Drive System | Linvatec Corp. | 2000 | — |
| 0 (this device) | K050519 | Advanced Turbo Drive System | Linvatec Corp. | 2005 | — |
| +1 | K130497 | D4000 Drive System; D4000A Drive System with Irrigation | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002523 | Advantage Drive SystemSummary page 5…TEC CORPORATION Advantage® Turbo Drive System Special 510(k) # A~6Stob9 February 18, 2005 D. Predicate/Legally Marketed Devices Advantage Drive System K002523 Linvatec Corporation E. Device Description The Advantage® Turbo Drive System device description is identical to the… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130497 | D4000 Drive System; D4000A Drive System with Irrigation | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2013 | Class III | Z-0916-2013 | Error in labeling | 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 edition IEC60606-01 Medical Electrical… |
| Jan 24, 2013 | Class III | Z-0917-2013 | Error in labeling | 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 edition IEC60606-01 Medical Electrical… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GEY devicesGEY Motor, Surgical Instrument, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEY
FDA has decided no GEY device since 2007.
Median 510(k) review, days · GEY
Too few GEY 510(k)s in any year since 2007 to give a median.
Recalls per year · GEY
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEY
965in 2025
MAUDE reports naming product code GEY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 19 |
| 2008 | 0 | — | 1 | 9 |
| 2009 | 0 | — | 1 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 1 | 14 |
| 2013 | 0 | — | 2 | 901 |
| 2014 | 0 | — | 0 | 738 |
| 2015 | 0 | — | 0 | 2,013 |
| 2016 | 0 | — | 0 | 1,943 |
| 2017 | 0 | — | 0 | 2,119 |
| 2018 | 0 | — | 0 | 1,288 |
| 2019 | 0 | — | 0 | 1,131 |
| 2020 | 0 | — | 0 | 952 |
| 2021 | 0 | — | 0 | 1,145 |
| 2022 | 0 | — | 0 | 1,360 |
| 2023 | 0 | — | 0 | 1,444 |
| 2024 | 0 | — | 0 | 1,447 |
| 2025 | 0 | — | 0 | 965 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050519: Advanced Turbo Drive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050519
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026