510(k) · Cleared
ClearedVuePoint OCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · NKG Posterior Cervical Screw System
Cleared on Jan 7, 2016 as substantially equivalent to K150474 (Nu Vasive, Incorporated, 2015) after a 49-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Jan 7, 2016
- Review
- 49 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953076 (1997). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 4 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 3 generations backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- 2 generations backK151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc. · 2015
- 1 generation backK150474 NuVasive VuePoint II OCT SystemNu Vasive, Incorporated · 2015
- This deviceK153336 VuePoint OCT SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 1 of its ownK171250 BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical · 2017
- Descendant · 2 generations on · 0 of its ownK220570 M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −4 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −3 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| −2 | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | Depuy Synthes, Inc. | 2015 | — |
| −1 | K150474 | NuVasive VuePoint II OCT System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K153336 | VuePoint OCT System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K171250 | BRIDALVEIL Occipital Cervical Thoracic System | Astura Medical | 2017 | — |
| +2 | K220570 | M.U.S.T. MINI Posterior Cervical Screws System Extension | Medacta International S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K150474 | NuVasive VuePoint II OCT SystemSummary page 4…e: KWP Class II C. Predicate Devices The subject device is substantially equivalent to the primary predicate device NuVasive® VuePoint® II OCT System (K150474) and the reference device NuVasive® VuePoint® OCT System (K093319). D. Device Description The NuVasive® VuePoint® OC… | 2015 |
| † | K093319 | Nuvasive Vuepoint Oct System | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171250 | BRIDALVEIL Occipital Cervical Thoracic System | 2017 | 1 |
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 5 companies; a new generation was cleared every 7 months on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K171250 (Astura Medical, 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K150474.
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 NuVasive® VuePoint® OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and…
Read the full statement (177 words)
The NuVasive® VuePoint® OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); 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 VuePoint OCT 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 advanced 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 VuePoint OCT System may be connected to the NuVasive SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline™ System via the rod to rod connectors or transition rods.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153336: VuePoint OCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153336
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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