510(k) · Cleared
ClearedNexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 12, 2021 as substantially equivalent to K132029 (Spinal USA, 2013) and 3 other predicates after an 85-day review. Its family tree reaches back 16 generations to 2001.
- Decided
- Jan 12, 2021
- Review
- 85 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K003155 (2001). 196 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK112388 Lanx Cervical SALanx, Inc. · 2011
- 2 generations backK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
- 1 generation backK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
- This deviceK203129 NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF)…Precision Spine, Inc. · 2021
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 6 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 5 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
- 3 generations backK112388 Lanx Cervical SALanx, Inc. · 2011
- 2 generations backK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
- 1 generation backK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
- This deviceK203129 NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF)…Precision Spine, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −6 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −5 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K094042 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek | 2010 | — |
| −3 | K112388 | Lanx Cervical SA | Lanx, Inc. | 2011 | — |
| −2 | K132894 | Optio-C Anterior Cervical System | Zimmer Spine, Inc. | 2014 | — |
| −1 | K173077 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2018 | — |
| 0 (this device) | K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System | Precision Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 28 | 0 |
| 2009 | 16 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K132029 | Vault-C Intervertebral Body Fusion DeviceSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K132029 Vault-C Standalone Cervical Spinal USA, Inc. Primary Interbody Fusio… | 2013 |
| * | K173077 | Cavetto-SA Cervical Cage SystemSummary page 5…Type K132029 Vault-C Standalone Cervical Spinal USA, Inc. Primary Interbody Fusion System K173077 Cavetto®-SA Cervical Neurostructures, Inc. Additional System K102… | 2018 |
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 5…Interbody Fusion System K173077 Cavetto®-SA Cervical Neurostructures, Inc. Additional System K102606 AVS® Anchor-C Cervical Stryker Spine Additional Cage System… | 2011 |
| * | K152793 | Unison-C Anterior Cervical Fixation SystemSummary page 5…System K102606 AVS® Anchor-C Cervical Stryker Spine Additional Cage System K152793 Unison-C Anterior Cervical RTI Surgical Additional Fixation Sys… | 2016 |
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 20 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 22 of the 196 ancestors have a recall of any class.
- 5 other devices also cite its predicate K132029.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The NexGen Standalone ACDF System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The NexGen implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203129: NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203129
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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