510(k) · Cleared
ClearedNuvasive Spherx II - Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 6, 2009 as substantially equivalent to K061778 (Nuvasive, Inc., 2006) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 2006. 72 later devices descend from it.
- Decided
- Oct 6, 2009
- Review
- 69 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K061778 (2006). 72 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK061778 Nuvasive Spherx II SystemNuvasive, Inc. · 2006
- 1 generation backK091502 Nuvasive Spherx II SystemNuvasive, Inc. · 2009
- This deviceK092287 Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc. · 2009
- Descendant · cites it directly · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 3 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- Descendant · 4 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- Descendant · cites it directly · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K132361Everest Spinal SystemK2m, Inc. · 2013 · cites it directly34descendants
- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · 2 generations on33descendants
- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 3 generations on30descendants
- K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 4 generations on16descendants
- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K061778 | Nuvasive Spherx II System | Nuvasive, Inc. | 2006 | — |
| −1 | K091502 | Nuvasive Spherx II System | Nuvasive, Inc. | 2009 | — |
| 0 (this device) | K092287 | Nuvasive Spherx II - Pedicle Screw System | Nuvasive, Inc. | 2009 | — |
| +1 | K132361 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +2 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +3 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +4 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| +1 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K061778 | Nuvasive Spherx II SystemSummary page 1…NKB, KWVP, MNI, MNH, KWQ C. Predicate Devices The subject SpheRx II -Pedicle Screw S'stem is substantially equivalent to the S'pheRx II ,S},stem (K061778 & K091502) currently distributed commercially in the U.S. by NuVasive. D. Device Description The N/uVasive SpheRx I… | 2006 |
| * | K091502 | Nuvasive Spherx II SystemSummary page 1…NKB, KWVP, MNI, MNH, KWQ C. Predicate Devices The subject SpheRx II -Pedicle Screw S'stem is substantially equivalent to the S'pheRx II ,S},stem (K061778 & K091502) currently distributed commercially in the U.S. by NuVasive. D. Device Description The N/uVasive SpheRx I! -Pedicle… | 2009 |
What descends from it? (72)
See all 725 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 3 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132361 (K2m, Inc., 2013) has gone furthest, with 34 descendants of its own.
- 2 other devices also cite its predicate K061778.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed…
Read the full statement (231 words)
When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:
1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)
The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:
1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092287: Nuvasive Spherx II - 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/K092287
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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