510(k) · Cleared
Recalled · 2007Harmony Port System, Model 1907 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Apr 15, 2005 as substantially equivalent to K992898 (Bright Medical Instruments, 1999) after a 28-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 15, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- GZT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992898 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992898 The Bright Medical Dilation Retractor SystemBright Medical Instruments · 1999
- This deviceK050706 Harmony Port System, Model 1907 SeriesSpinal Concepts, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK071771 Instrumed RetractorsInstrumed International, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK161004 Self-retaining RetractorFetzer Medical GmbH & Co. KG · 2016
- Descendant · 3 generations on · 0 of its ownK161680 MEDICON Spinal Spreading SystemsMedicon EG · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992898 | The Bright Medical Dilation Retractor System | Bright Medical Instruments | 1999 | — |
| 0 (this device) | K050706 | Harmony Port System, Model 1907 Series | Spinal Concepts, Inc. | 2005 | — |
| +1 | K071771 | Instrumed Retractors | Instrumed International, Inc. | 2007 | — |
| +2 | K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016 | — |
| +3 | K161680 | MEDICON Spinal Spreading Systems | Medicon EG | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K992898 | The Bright Medical Dilation Retractor SystemSummary page 1…The Bright Medical Dilation Retractor System manufactured by Bright Medical Instruments, K992898, cleared October 21, 1999. DEVICE DESCRIPTION: The Harmony Port System includes the Harmony… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071771 | Instrumed Retractors | 2007 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2007 | Not classified | Z-0880-2008 | Device Design | Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050706 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050706: Harmony Port System, Model 1907 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050706
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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