510(k) · Cleared
ClearedNuvasive Traverse Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 3, 2011 as substantially equivalent to K082070 (Nuvasive, Inc., 2008) and 2 other predicates after a 70-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Mar 3, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K061778 (2006). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK061778 Nuvasive Spherx II SystemNuvasive, Inc. · 2006
- 2 generations backK091502 Nuvasive Spherx II SystemNuvasive, Inc. · 2009
- 1 generation backK102514 Nuvasive Spherx II -Mas Deformity Spinal SystemNuvasive, Inc. · 2010
- This deviceK103750 Nuvasive Traverse Plate SystemNuvasive, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK200956 NuVasive Thoracolumbar PlatesNu Vasive, Incorporated · 2020
Most influential descendants
Showing 1 of 1 · See all- K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061778 | Nuvasive Spherx II System | Nuvasive, Inc. | 2006 | — |
| −2 | K091502 | Nuvasive Spherx II System | Nuvasive, Inc. | 2009 | — |
| −1 | K102514 | Nuvasive Spherx II -Mas Deformity Spinal System | Nuvasive, Inc. | 2010 | — |
| 0 (this device) | K103750 | Nuvasive Traverse Plate System | Nuvasive, Inc. | 2011 | — |
| +1 | K200956 | NuVasive Thoracolumbar Plates | Nu Vasive, Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K082070 | Nuvasive Lateral Plate SystemSummary page 1…The subject Traverse Plate System is substantially equivalent to the following predicate devices currently distributed commercially in the U.S.: " K082070 -NuVasive Traverse Plate System * K070273 - NuVasive Lateral Plate System * K102514 -NuVasive SpheRx 11 - MAS… | 2008 |
| * | K070273 | Modification to Nuvasive Lateral Plate SystemSummary page 1…ally equivalent to the following predicate devices currently distributed commercially in the U.S.: " K082070 -NuVasive Traverse Plate System * K070273 - NuVasive Lateral Plate System * K102514 -NuVasive SpheRx 11 - MAS Deformity Spinal System D. Device Description… | 2007 |
| * | K102514 | Nuvasive Spherx II -Mas Deformity Spinal SystemSummary page 1…vices currently distributed commercially in the U.S.: " K082070 -NuVasive Traverse Plate System * K070273 - NuVasive Lateral Plate System * K102514 -NuVasive SpheRx 11 - MAS Deformity Spinal System D. Device Description The Traverse Plate System consists of a varie… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200956 | NuVasive Thoracolumbar Plates | 2020 | 0 |
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 5 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K200956 (Nu Vasive, Incorporated, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082070.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The NuVasive Traverse Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (Li-Si) spine instability as a result of: 1. Fracture (including dislocation and…
Read the full statement (111 words)
The NuVasive Traverse Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (Li-Si) spine instability as a result of:
1. Fracture (including dislocation and subluxation)
2. Tumor
3. Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
4. Scoliosis
5. Kyphosis
6. Lordlosis
7. Spinal stenosis
8. Failed previous spine surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103750 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103750: Nuvasive Traverse Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103750
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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