510(k) · Cleared
Recalled · Class II · 2009Nuvasive Spherx 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 10, 2008 after a 57-day review. The FDA summary names its predicate without a number. It has been recalled 31 times.
- Decided
- Oct 10, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 31
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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® HI System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2009 | Class II | Z-0348-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0355-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0359-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0366-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0368-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0372-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0357-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0358-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0360-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0364-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0367-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0370-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0373-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0349-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0351-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0353-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0362-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0365-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0369-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0371-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0374-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0375-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0376-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0377-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0350-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0352-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0354-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0356-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0361-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0363-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Class II | Z-0378-2013 | Device Design | The tulip portion of the screw assembly can disengage from the shank after implantation. |
The 5 latest of 31 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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/K082332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082332: Nuvasive Spherx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082332
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026