510(k) · Cleared
ClearedQUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MANTIZ Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 24, 2026 as substantially equivalent to K210420 (Medynus, Inc., 2021) after a 170-day review. Its family tree reaches back 11 generations to 1999.
- Decided
- Jul 24, 2026
- Review
- 170 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K990745 (1999). 61 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- 1 generation backK210420 Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021
- This deviceK260362 QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal…MANTIZ Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 5 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 4 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- 1 generation backK210420 Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021
- This deviceK260362 QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal…MANTIZ Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −5 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −4 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −3 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −2 | K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | 2017 | — |
| −1 | K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | 2021 | — |
| 0 (this device) | K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… | MANTIZ Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | K210420 | Goblin and Goblin LS Pedicle Screw SystemsSummary page 5…888.3070 Product Code(s) NKB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K210420 Goblin and Goblin LS Pedicle Screw Systems NKB Device Description Summary 21 CFR 807.92(a)(4) The subject device is a posterior… | 2021 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 61 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The QUATTRO Spinal System are intended for posterior, non-cervical fixation in skeletally mature patients
as an adjunct to fusion for the following indications:
* Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies);
» Spondylolisthesis;
* Trauma (i.e., fracture or dislocation);
* Spinal stenosis;
* Curvatures (i.e., scoliosis, kyphosis and/or lordosis);
* Tumor and pseudarthrosis
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260362: QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260362
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026