510(k) · Cleared
ClearedSynthes Zero-P Variable Angle (VA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jul 25, 2012 as substantially equivalent to K093762 (Synthes Spine, 2010) and 2 other predicates after a 30-day review. Its family tree reaches back 13 generations to 2001. 30 later devices descend from it.
- Decided
- Jul 25, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K003155 (2001). 51 ancestors in all, the oldest K792352 (1979). 30 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK112068 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · Recalled
- This deviceK121852 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012
- Descendant · cites it directly · 24 of its ownK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- Descendant · 2 generations on · 23 of its ownK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- Descendant · 3 generations on · 16 of its ownK172489 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017
- Descendant · 2 generations on · 15 of its ownK173102 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017
- Descendant · 3 generations on · 6 of its ownK212358 Romero Cervical CageSpineup, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK112068 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · Recalled
- This deviceK121852 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013 · cites it directly24descendants
- K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015 · 2 generations on23descendants
- K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017 · 3 generations on16descendants
- K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017 · 2 generations on15descendants
- K212358Romero Cervical CageSpineup, Inc. · 2022 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −3 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −2 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −1 | K112068 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2011 | 1 |
| 0 (this device) | K121852 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2012 | — |
| +1 | K131429 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2013 | — |
| +2 | K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015 | — |
| +3 | K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | — |
| +2 | K173102 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | — |
| +3 | K212358 | Romero Cervical Cage | Spineup, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K093762 | Synthes Zero-PSummary page 1…Product Code OVE (Intervertebral Fusion. Device with Integrated Fixation, Cervical) Predicates: Synthes Zero-P device (K093762, K1 12459) Synthes Zero-P VA device (K1 12068) Device Description: The Synthes Zero-P VA is a r… | 2010 |
| * | K112459 | Synthes Zero-PSummary page 1…roduct Code OVE (Intervertebral Fusion. Device with Integrated Fixation, Cervical) Predicates: Synthes Zero-P device (K093762, K1 12459) Synthes Zero-P VA device (K1 12068) Device Description: The Synthes Zero-P VA is a radiolucent… | 2011 |
| * | K112068 | Synthes Zero-P Variable Angle (VA)Summary page 1…Fixation, Cervical) Predicates: Synthes Zero-P device (K093762, K1 12459) Synthes Zero-P VA device (K1 12068) Device Description: The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body f… | 2011 |
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 7 of the 51 ancestors have a recall of any class.
- Of its descendants, K131429 (Reliance Medical Systems, LLC, 2013) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K093762.
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. 2012, 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 Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. ODD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121852: Synthes Zero-P Variable Angle (VA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121852
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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