510(k) · Cleared
ClearedZimmer Virage OCT Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · NKG Posterior Cervical Screw System
Cleared on Feb 16, 2016 as substantially equivalent to K151031 (Zimmer Spine, Inc., 2015) after a 60-day review. Its family tree reaches back 4 generations to 1997. 18 later devices descend from it.
- Decided
- Feb 16, 2016
- Review
- 60 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953076 (1997). 5 ancestors in all. 18 later devices descend from it, 10 citing it directly.
- Root · 4 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 3 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 2 generations backK143471 VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK151031 Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2015
- This deviceK153631 Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK191185 Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019
- Descendant · cites it directly · 3 of its ownK201481 Centurion POCT SystemOrthofix, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK211710 Ascent POCT System, Centurion POCT System, Spinal Fixation System…Orthofix, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019 · cites it directly4descendants
- K201481Centurion POCT SystemOrthofix, Inc. · 2020 · cites it directly3descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · cites it directly3descendants
- K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc. · 2021 · 2 generations on2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −3 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −2 | K143471 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K151031 | Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | 2015 | — |
| 0 (this device) | K153631 | Zimmer Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | 2016 | — |
| +1 | K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine | 2019 | — |
| +1 | K201481 | Centurion POCT System | Orthofix, Inc. | 2020 | — |
| +1 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +2 | K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS)… | Orthofix, Inc. | 2021 | — |
| +2 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 NKG? 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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 |
|---|---|---|---|
| * | K151031 | Virage OCT Spinal Fixation SystemSummary page 4…Product Code: KWP Class II Primary Predicate Device: Virage OCT Spinal Fixation System, K151031 Reference Devices: Virage OCT Spinal Fixation System (K133556);… | 2015 |
| † | K133556 | Virage Oct Spinal Fixation System | 2014 |
| † | K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation System | 2007 |
| † | K071435 | Nuvasive Oct System | 2007 |
What descends from it? (18)
See all 1810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191185 | Solanas® Posterior OCT Fixation System | 2019 | 4 |
| K201481 | Centurion POCT System | 2020 | 3 |
| K200936 | Invictus™ CT Spinal Fixation System | 2020 | 3 |
| K220132 | FIREFLY® Cervical Navigation Guide | 2022 | 1 |
| K172495 | Reform® POCT System | 2018 | 1 |
| K171250 | BRIDALVEIL Occipital Cervical Thoracic System | 2017 | 1 |
| K250332 | Virage® OCT Spinal Fixation System | 2025 | 0 |
| K203125 | Invictus™ OCT Spinal Fixation System | 2020 | 0 |
| K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | 2020 | 0 |
| K171834 | G Surgical OCT Spinal System | 2017 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191185 (Alphatec Spine, 2019) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K151031.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The Zimmer Virage® OCT Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical…
Read the full statement (227 words)
The Zimmer Virage® OCT Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Zimmer Virage® OCT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, The Zimmer Virage® OCT Spinal Fixation System may be connected to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine, using rod connectors and transition rods. Refer to the Instinct Java and Sequoia Spinal System package insert for a list of the system specific indications of use.
The titanium SONGER® Spinal Cable System to be used with the Zimmer Virage® OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153631: Zimmer Virage OCT Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153631
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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