510(k) · Cleared
ClearedSelf-retaining Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fetzer Medical GmbH & Co. KG · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Sep 9, 2016 as substantially equivalent to K071771 (Instrumed International, Inc., 2007) and 1 other predicate after a 151-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Sep 9, 2016
- Review
- 151 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K992898 (1999). 5 ancestors in all, the oldest K935529 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK992898 The Bright Medical Dilation Retractor SystemBright Medical Instruments · 1999
- 2 generations backK050706 Harmony Port System, Model 1907 SeriesSpinal Concepts, Inc. · 2005 · Recalled
- 1 generation backK071771 Instrumed RetractorsInstrumed International, Inc. · 2007
- This deviceK161004 Self-retaining RetractorFetzer Medical GmbH & Co. KG · 2016
- Descendant · cites it directly · 0 of its ownK161680 MEDICON Spinal Spreading SystemsMedicon EG · 2017
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −3 | K992898 | The Bright Medical Dilation Retractor System | Bright Medical Instruments | 1999 | — |
| −2 | K050706 | Harmony Port System, Model 1907 Series | Spinal Concepts, Inc. | 2005 | 1 |
| −1 | K071771 | Instrumed Retractors | Instrumed International, Inc. | 2007 | — |
| 0 (this device) | K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016 | — |
| +1 | K161680 | MEDICON Spinal Spreading Systems | Medicon EG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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? (2)
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 |
|---|---|---|---|
| * | K071771 | Instrumed RetractorsSummary page 4…GZT 2. Predicate Device: Trade name Instrumed Retractors Versatrac™ Lumbar Retractor System 510(k) No. K071771 K964402 510(k) submitter / holder INSTRUMED INTERNATIONAL, INC. I V. Mueller Neuro/Spine… | 2007 |
| * | K964402 | Versatrac (TM) Lumbar Retractor SystemSummary page 4…ice: Trade name Instrumed Retractors Versatrac™ Lumbar Retractor System 510(k) No. K071771 K964402 510(k) submitter / holder INSTRUMED INTERNATIONAL, INC. I V. Mueller Neuro/Spine 626 Cooper… | 1997 |
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 |
|---|---|---|---|
| K161680 | MEDICON Spinal Spreading Systems | 2017 | 0 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K161680 (Medicon EG, 2017) has gone furthest, with 0 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. 2016, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161004: Self-retaining Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161004
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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