510(k) · Cleared
ClearedMEDICON Spinal Spreading Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicon EG · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Mar 24, 2017 as substantially equivalent to K161004 (Fetzer Medical GmbH & Co. KG, 2016) and 2 other predicates after a 280-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Mar 24, 2017
- Review
- 280 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K992898 (1999). 6 ancestors in all, the oldest K935529 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK992898 The Bright Medical Dilation Retractor SystemBright Medical Instruments · 1999
- 3 generations backK050706 Harmony Port System, Model 1907 SeriesSpinal Concepts, Inc. · 2005 · Recalled
- 2 generations backK071771 Instrumed RetractorsInstrumed International, Inc. · 2007
- 1 generation backK161004 Self-retaining RetractorFetzer Medical GmbH & Co. KG · 2016
- This deviceK161680 MEDICON Spinal Spreading SystemsMedicon EG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992898 | The Bright Medical Dilation Retractor System | Bright Medical Instruments | 1999 | — |
| −3 | K050706 | Harmony Port System, Model 1907 Series | Spinal Concepts, Inc. | 2005 | 1 |
| −2 | K071771 | Instrumed Retractors | Instrumed International, Inc. | 2007 | — |
| −1 | K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016 | — |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K161004 | Self-retaining Retractor Cleared while this submission was under review Summary page 4…ng Versatrac™ Lumbar Retractor Cervical Self-Retaining Retractor Retractors System 510(k) No.: K161004 K964402 K935529 510(k) submitter: Fetzer Medical GmbH & Co. KG I V.… | 2016 |
| * | K964402 | Versatrac (TM) Lumbar Retractor SystemSummary page 4…Cervical Self-Retaining Retractor Retractors System 510(k) No.: K161004 K964402 K935529 510(k) submitter: Fetzer Medical GmbH & Co. KG I V. Mueller… | 1997 |
| * | K935529 | Cervical Self-Retaining RetractorSummary page 4…ractor Retractors System 510(k) No.: K161004 K964402 K935529 510(k) submitter: Fetzer Medical GmbH & Co. KG I V. Mueller Koros Surgical Instruments, Corp… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2017, 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?
The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161680 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161680: MEDICON Spinal Spreading Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161680
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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