510(k) · Cleared
ClearedQuadrant Retractor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · GAD Retractor
Cleared on Feb 23, 2005 as substantially equivalent to K002931 (Medtronic Sofamor Danek, Inc., 2000) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 2000. 1 of the 32 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Feb 23, 2005
- Review
- 56 days
- Class
- Class I
- Product code
- GAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002931 (2000). 2 ancestors in all. 29 later devices descend from it, 5 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
- This deviceK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- Descendant · 2 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- Descendant · cites it directly · 10 of its ownK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK120691 Brain PortNico Corporation · 2012 · Recalled
- Descendant · 3 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060973 Vycor Surgical Access Systemscites it directly · 2006
Most influential descendants
Showing 5 of 29 · See all- K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · cites it directly14descendants
- K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 2 generations on13descendants
- K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · cites it directly10descendants
- K120691Brain PortNico Corporation · 2012 · 2 generations on8descendants
- K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| 0 (this device) | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| +2 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| +1 | K060973 | Vycor Surgical Access Systems | Vycor Medical, LLC | 2006 | Class I |
| +2 | K120691 | Brain Port | Nico Corporation | 2012 | 2 |
| +3 | K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K002931 | Metrx SystemSummary page 2…QUADRANT TM Retractors to be substantially equivalent to the METRx, MED, Inclusive, and/or INCL Microscopes described in Medtronic Sofamor Danek 510(k) No. K002931 (SE 11/24/00), while the pedicle access needles included in the system are identical to those cleared in the EQUEST… | 2000 |
| * | K040483 | Equestra Fluid Delivery SystemSummary page 2…No. K002931 (SE 11/24/00), while the pedicle access needles included in the system are identical to those cleared in the EQUESTRA TM Fluid Delivery System (K040483, SE 07/23/04). - *2. At'h === P… | 2004 |
What descends from it? (29)
See all 295 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All GAD devicesGAD Retractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAD
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GAD
Too few GAD 510(k)s in any year since 2007 to give a median.
Recalls per year · GAD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAD
107in 2025
MAUDE reports naming product code GAD, 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 | 1 | — | 0 | 38 |
| 2008 | 0 | — | 1 | 45 |
| 2009 | 0 | — | 1 | 64 |
| 2010 | 0 | — | 0 | 52 |
| 2011 | 0 | — | 0 | 50 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 3 | 88 |
| 2014 | 0 | — | 2 | 80 |
| 2015 | 0 | — | 1 | 67 |
| 2016 | 2 | — | 0 | 78 |
| 2017 | 0 | — | 0 | 90 |
| 2018 | 0 | — | 0 | 77 |
| 2019 | 0 | — | 0 | 62 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 81 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 80 |
| 2024 | 0 | — | 1 | 111 |
| 2025 | 0 | — | 0 | 107 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The MAST QUADRANT TM Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variett of spinal fixation procedures utilizing a minimally invasive approach. The MAST QUADRANT TM Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar…
Read the full statement (139 words)
The MAST QUADRANT TM Retractor System is intended to provide surgeons with instruments such as dilators, retractors, light sources and pedicle access needles used to perform a variett of spinal fixation procedures utilizing a minimally invasive approach.
The MAST QUADRANT TM Retractor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the MAST QUADRANTTNI Retractors and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nacleus material, spinal fusion, or insertion of spinal implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043602: Quadrant 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/K043602
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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