510(k) · Cleared
ClearedNuvasive Lateral 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 Sep 24, 2008 after a 64-day review. The FDA summary names no predicate by number. 76 later devices descend from it.
- Decided
- Sep 24, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
76 later devices descend from it, 3 citing it directly.
- This deviceK082070 Nuvasive Lateral Plate SystemNuvasive, Inc. · 2008
- Descendant · cites it directly · 74 of its ownK091071 Nuvasive Lateral Plate SystemNuvasive, Inc. · 2009
- Descendant · 2 generations on · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014
- Descendant · 2 generations on · 41 of its ownK120092 Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012
- Descendant · 3 generations on · 24 of its ownK150449 LITe Plate SystemStryker Corp. · 2015
- Descendant · cites it directly · 17 of its ownK133194 Diamond Rattlesnake SystemEminent Spine · 2014
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K091071Nuvasive Lateral Plate SystemNuvasive, Inc. · 2009 · cites it directly74descendants
- K142699LITe Plate SystemStryker Corporation · 2014 · 2 generations on46descendants
- K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc. · 2012 · 2 generations on41descendants
- K150449LITe Plate SystemStryker Corp. · 2015 · 3 generations on24descendants
- K133194Diamond Rattlesnake SystemEminent Spine · 2014 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082070 | Nuvasive Lateral Plate System | Nuvasive, Inc. | 2008 | — |
| +1 | K091071 | Nuvasive Lateral Plate System | Nuvasive, Inc. | 2009 | — |
| +2 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| +2 | K120092 | Plymouth Thoracolumbar Plate System | Globus Medical, Inc. | 2012 | — |
| +3 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| +1 | K133194 | Diamond Rattlesnake System | Eminent Spine | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 9 | 0 |
| 2023 | 13 | 0 |
| 2024 | 10 | 0 |
| 2025 | 5 | 0 |
| 2026 | 8 | 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?
The FDA summary names no predicate by number.
What descends from it? (76)
See all 763 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?
- Of its descendants, K091071 (Nuvasive, Inc., 2009) has gone furthest, with 74 descendants of its own.
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. 2008, 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 Lateral 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 fracture (including dislocation and…
Read the full statement (104 words)
The NuVasive Lateral 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 fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082070: Nuvasive Lateral 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/K082070
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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