510(k) · Cleared
ClearedAuxein Brand Vertaux 5.5 mm Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical Private Limited/71164 · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 6, 2021 as substantially equivalent to K091442 (Medtronic Sofamor Danek, 2009) after a 309-day review. Its family tree reaches back 8 generations to 2004. 2 later devices descend from it.
- Decided
- Apr 6, 2021
- Review
- 309 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K040583 (2004). 41 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 5 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 3 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- This deviceK201457 Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/71164 · 2021
- Descendant · cites it directly · 0 of its ownK243281 LOCK-IN Spinal Fixation SystemLock-In USA Corp · 2024
- Descendant · cites it directly · 0 of its ownK240233 Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −5 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −3 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −1 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K201457 | Auxein Brand Vertaux 5.5 mm Pedicle Screw System | Auxein Medical Private Limited/71164 | 2021 | — |
| +1 | K243281 | LOCK-IN Spinal Fixation System | Lock-In USA Corp | 2024 | — |
| +1 | K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K091442 | CD Horizon Spinal SystemSummary page 5…sslink-II 6 VERTAUX Rod A.3) Identification of the Predicate Device: The identified primary predicate within this submission is as follows: K 091442, Medtronic Sofamor Danek, USA, CD HORIZON Spinal System A.4).Adescriptionofthedevicethatisthesubjectofthepremarketnotificationsu… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 months on median.
- 5 of the 41 ancestors have a recall of any class.
- Of its descendants, K243281 (Lock-In USA Corp, 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K091442.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Auxein Brand Vertaux 5.5 mm Pedicle Screw System is 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 as stated in the FDA summary.
https://510kreport.com/device/K201457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201457: Auxein Brand Vertaux 5.5 mm Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201457
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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