510(k) · Cleared
ClearedNuvasive Sage 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 Oct 23, 2012 as substantially equivalent to K061789 (Nuvasive, Inc., 2006) and 2 other predicates after a 125-day review. Its family tree reaches back 3 generations to 2002. 1 of the 477 devices in its family, counting itself, has a Class I recall. 469 later devices descend from it.
- Decided
- Oct 23, 2012
- Review
- 125 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K022791 (2002). 7 ancestors in all, the oldest K994121 (2000). 469 later devices descend from it, 2 citing it directly. 1 of the 477 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
- 2 generations backK063158 Synthes Antegra SystemSynthes Spine Co.Lp · 2006
- 1 generation backK081568 Antegra-TSynthes Spine Co.Lp · 2008
- This deviceK121815 Nuvasive Sage Lateral Plate SystemNuvasive, Inc. · 2012
- Descendant · cites it directly · 466 of its ownK131723 Coroent Single Tab SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 465 of its ownK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
Showing 5 of 469 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 469 · See all- K131723Coroent Single Tab SystemNuvasive, Inc. · 2013 · cites it directly466descendants
- K140479Coroent XL-F SystemNu Vasive, Incorporated · 2014 · 2 generations on465descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 2 generations on396descendants
- K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 2 generations on390descendants
- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 3 generations on381descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022791 | Synthes Anterior Tension Band (Atb) System | Synthes (Usa) | 2002 | — |
| −2 | K063158 | Synthes Antegra System | Synthes Spine Co.Lp | 2006 | — |
| −1 | K081568 | Antegra-T | Synthes Spine Co.Lp | 2008 | — |
| 0 (this device) | K121815 | Nuvasive Sage Lateral Plate System | Nuvasive, Inc. | 2012 | — |
| +1 | K131723 | Coroent Single Tab System | Nuvasive, Inc. | 2013 | — |
| +2 | K140479 | Coroent XL-F System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 24 | 0 |
| 2020 | 43 | 0 |
| 2021 | 43 | 1 |
| 2022 | 52 | 0 |
| 2023 | 59 | 0 |
| 2024 | 81 | 0 |
| 2025 | 64 | 0 |
| 2026 | 54 | 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.
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 |
|---|---|---|---|
| * | K061789 | Lateral Plate SystemSummary page 1…. Predicate Devices The subject Sage Lateral Plate System is substantially equivalent to the following predicate devices: JNuVasive®o Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). D. Device Description The NuVasi… | 2006 |
| * | K072339 | Nuvasive Anterior Lumbar Plate SystemSummary page 1…teral Plate System is substantially equivalent to the following predicate devices: JNuVasive®o Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). D. Device Description The NuVasive Sage Lateral Plate System is an anterior/ant… | 2007 |
| * | K081568 | Antegra-TSummary page 1…ivalent to the following predicate devices: JNuVasive®o Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be… | 2008 |
What descends from it? (469)
See all 4692 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K131723 (Nuvasive, Inc., 2013) has gone furthest, with 466 descendants of its own.
- 3 other devices also cite its predicate K061789.
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. 2012, 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 Sage Lateral Plate System is indicated for use 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/K121815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121815: Nuvasive Sage Lateral Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121815
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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