510(k) · Cleared
ClearedNuvasive Spherx II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 18, 2006 after a 22-day review. The FDA summary names its predicate without a number. 154 later devices descend from it.
- Decided
- Jul 18, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
154 later devices descend from it, 3 citing it directly.
- This deviceK061778 Nuvasive Spherx II SystemNuvasive, Inc. · 2006
- Descendant · cites it directly · 153 of its ownK091502 Nuvasive Spherx II SystemNuvasive, Inc. · 2009
- Descendant · cites it directly · 82 of its ownK132014 GSB Global Spinal Balance SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 78 of its ownK142499 Reline SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 77 of its ownK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 72 of its ownK092287 Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc. · 2009
Showing 5 of 154 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 154 · See all- K091502Nuvasive Spherx II SystemNuvasive, Inc. · 2009 · cites it directly153descendants
- K132014GSB Global Spinal Balance SystemNuvasive, Inc. · 2013 · cites it directly82descendants
- K142499Reline SystemNu Vasive, Incorporated · 2014 · 2 generations on78descendants
- K143684NuVasive Reline SystemNu Vasive, Incorporated · 2015 · 2 generations on77descendants
- K092287Nuvasive Spherx II - Pedicle Screw SystemNuvasive, Inc. · 2009 · cites it directly72descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061778 | Nuvasive Spherx II System | Nuvasive, Inc. | 2006 | — |
| +1 | K091502 | Nuvasive Spherx II System | Nuvasive, Inc. | 2009 | — |
| +1 | K132014 | GSB Global Spinal Balance System | Nuvasive, Inc. | 2013 | — |
| +2 | K142499 | Reline System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K092287 | Nuvasive Spherx II - Pedicle Screw System | Nuvasive, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 9 | 0 |
| 2023 | 23 | 0 |
| 2024 | 15 | 0 |
| 2025 | 12 | 0 |
| 2026 | 14 | 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | SpheRx System Named without a submission number |
What descends from it? (154)
See all 1543 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, K091502 (Nuvasive, Inc., 2009) has gone furthest, with 153 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
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/K061778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061778: Nuvasive Spherx II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061778
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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