510(k) · Cleared
ClearedINNOVERSE Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innosys Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 6, 2024 as substantially equivalent to K231737 (Innosys Co., Ltd., 2023) and 4 other predicates after a 53-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Feb 6, 2024
- Review
- 53 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K000319 (2000). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 6 generations between
- 3 generations backK162189 ANAX™ 5.5 Spinal SystemU&I Corporation · 2016
- 2 generations backK173524 ANAX 5.5™ Spinal SystemU&I Corporation · 2017 · Recalled
- 1 generation backK231737 ANAX™ 5.5 Spinal SystemInnosys Co., Ltd. · 2023
- This deviceK233960 INNOVERSE Spinal SystemInnosys Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 9 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 8 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 7 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 6 generations backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- 5 generations backK132101 Anax 5.5 Spinal SystemU&I Corporation · 2013
- 4 generations backK143417 ANAX 5.5 Spinal SystemU&I Corporation · 2015
- 3 generations backK162189 ANAX™ 5.5 Spinal SystemU&I Corporation · 2016
- 2 generations backK173524 ANAX 5.5™ Spinal SystemU&I Corporation · 2017 · Recalled
- 1 generation backK231737 ANAX™ 5.5 Spinal SystemInnosys Co., Ltd. · 2023
- This deviceK233960 INNOVERSE Spinal SystemInnosys Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −9 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −8 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −7 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −6 | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| −5 | K132101 | Anax 5.5 Spinal System | U&I Corporation | 2013 | — |
| −4 | K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015 | — |
| −3 | K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016 | — |
| −2 | K173524 | ANAX 5.5™ Spinal System | U&I Corporation | 2017 | 1 |
| −1 | K231737 | ANAX™ 5.5 Spinal System | Innosys Co., Ltd. | 2023 | — |
| 0 (this device) | K233960 | INNOVERSE Spinal System | Innosys Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K231737 | ANAX™ 5.5 Spinal SystemSummary page 4…per 21 CFR 888.3070 Common Name: Thoracolumbosacral Pedicle Screw System Product Code: NKB Primary ANAXTM 5.5 Spinal System (K231737, K173524, K162189, Predicate Device: K143417, K132101) Description of Device: The INNOVERSE Spinal System is manufactur… | 2023 |
| * | K173524 | ANAX 5.5™ Spinal SystemSummary page 4…FR 888.3070 Common Name: Thoracolumbosacral Pedicle Screw System Product Code: NKB Primary ANAXTM 5.5 Spinal System (K231737, K173524, K162189, Predicate Device: K143417, K132101) Description of Device: The INNOVERSE Spinal System is manufactured by Inn… | 2017 |
| * | K162189 | ANAX™ 5.5 Spinal SystemSummary page 4…70 Common Name: Thoracolumbosacral Pedicle Screw System Product Code: NKB Primary ANAXTM 5.5 Spinal System (K231737, K173524, K162189, Predicate Device: K143417, K132101) Description of Device: The INNOVERSE Spinal System is manufactured by Innosys Co.,… | 2016 |
| * | K143417 | ANAX 5.5 Spinal SystemSummary page 4…acolumbosacral Pedicle Screw System Product Code: NKB Primary ANAXTM 5.5 Spinal System (K231737, K173524, K162189, Predicate Device: K143417, K132101) Description of Device: The INNOVERSE Spinal System is manufactured by Innosys Co., Ltd. The INNOVERSE Spinal System… | 2015 |
| * | K132101 | Anax 5.5 Spinal SystemSummary page 4…acral Pedicle Screw System Product Code: NKB Primary ANAXTM 5.5 Spinal System (K231737, K173524, K162189, Predicate Device: K143417, K132101) Description of Device: The INNOVERSE Spinal System is manufactured by Innosys Co., Ltd. The INNOVERSE Spinal System is a top-… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 17 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The INNOVERSE Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
* Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
* Degenerative spondylolisthesis with objective evidence of neurological impairment
* Trauma (i.e., fracture or dislocation)
* Spinal stenosis
* Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
* Tumor
* Pseudoarthrosis
* Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233960: INNOVERSE Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233960
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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