510(k) · Cleared
ClearedVersatrac (TM) Lumbar Retractor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
V. Mueller Neuro/Spine · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Jan 23, 1997 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 23, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK964402 Versatrac (TM) Lumbar Retractor SystemV. Mueller Neuro/Spine · 1997
- Descendant · cites it directly · 2 of its ownK071771 Instrumed RetractorsInstrumed International, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK180610 Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018
- Descendant · cites it directly · 1 of its ownK161004 Self-retaining RetractorFetzer Medical GmbH & Co. KG · 2016
- Descendant · 2 generations on · 0 of its ownK252995 Durashield Device KitSurGenTec, LLC · 2026
- Descendant · cites it directly · 0 of its ownK161680 MEDICON Spinal Spreading SystemsMedicon EG · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071771Instrumed RetractorsInstrumed International, Inc. · 2007 · cites it directly2descendants
- K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbH · 2018 · cites it directly1descendant
- K161004Self-retaining RetractorFetzer Medical GmbH & Co. KG · 2016 · cites it directly1descendant
- K252995Durashield Device KitSurGenTec, LLC · 2026 · 2 generations on0descendants
- K161680MEDICON Spinal Spreading SystemsMedicon EG · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964402 | Versatrac (TM) Lumbar Retractor System | V. Mueller Neuro/Spine | 1997 | — |
| +1 | K071771 | Instrumed Retractors | Instrumed International, Inc. | 2007 | — |
| +1 | K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | 2018 | — |
| +1 | K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016 | — |
| +2 | K252995 | Durashield Device Kit | SurGenTec, LLC | 2026 | — |
| +1 | K161680 | MEDICON Spinal Spreading Systems | Medicon EG | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZT device
- #1 K252995 Durashield Device Kitscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071771 (Instrumed International, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GZT devicesGZT Retractor, Self-Retaining, For Neurosurgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZT
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GZT
280in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZT
1in 2012
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GZT
1in 2025
MAUDE reports naming product code GZT, 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 | 2 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 1 (1) | 6 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 3 | 280 | 0 | 9 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K964402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964402: Versatrac (TM) Lumbar Retractor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964402
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026