510(k) · Cleared
Recalled · Class II · 2013Synthes 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 Nov 7, 2011 as substantially equivalent to K072981 (Synthes Spine Co.Lp, 2008) and 6 other predicates after a 110-day review. Its family tree reaches back 12 generations to 2001. 33 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2011
- Review
- 110 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 12 generations to K003155 (2001). 48 ancestors in all, the oldest K792352 (1979). 33 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 1 generation backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- This deviceK112068 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011
- Descendant · cites it directly · 30 of its ownK121852 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012
- Descendant · 2 generations on · 24 of its ownK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- Descendant · 3 generations on · 23 of its ownK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- Descendant · 4 generations on · 16 of its ownK172489 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017
- Descendant · 3 generations on · 15 of its ownK173102 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 1 generation backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- This deviceK112068 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012 · cites it directly30descendants
- K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013 · 2 generations on24descendants
- K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015 · 3 generations on23descendants
- K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017 · 4 generations on16descendants
- K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −2 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −1 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| 0 (this device) | K112068 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2011 | — |
| +1 | K121852 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2012 | — |
| +2 | K131429 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2013 | — |
| +3 | K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015 | — |
| +4 | K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | — |
| +3 | K173102 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K072981 | Synthes Zero-PSummary page 1…Product Code OVE (Intervertebral Fusion Device w/ Integrated Fixation, Cervical) Predicates: Synthes Zero-P device (K07298 1); Sulzer BAKTM/Cervical IBE (P980048); Synthes Vectra (K05045 1);… | 2008 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…Device w/ Integrated Fixation, Cervical) Predicates: Synthes Zero-P device (K07298 1); Sulzer BAKTM/Cervical IBE (P980048); Synthes Vectra (K05045 1); Synthes Vectra-T (KOS51665); Globu… | 2001 |
| * | K050451 | Synthes Vectra SystemSummary page 1…Cervical) Predicates: Synthes Zero-P device (K07298 1); Sulzer BAKTM/Cervical IBE (P980048); Synthes Vectra (K05045 1); Synthes Vectra-T (KOS51665); Globus Coalition (K083389) Medtr… | 2005 |
| * | K051665 | Synthes Vectra-T System | 2005 |
| * | K083389 | Coalition SpacerSummary page 1…BAKTM/Cervical IBE (P980048); Synthes Vectra (K05045 1); Synthes Vectra-T (KOS51665); Globus Coalition (K083389) Medtronic PEEK Prevail (K073285) RSB InterPlate C-P (K092070) Device Description:… | 2009 |
| * | K073285 | Peek Prevail Cervical Interbody DeviceSummary page 1…thes Vectra (K05045 1); Synthes Vectra-T (KOS51665); Globus Coalition (K083389) Medtronic PEEK Prevail (K073285) RSB InterPlate C-P (K092070) Device Description: The Synthes Zero-P VA is a radiolucent and radiopaque… | 2008 |
| * | K092070 | Interplate CSummary page 1…es Vectra-T (KOS51665); Globus Coalition (K083389) Medtronic PEEK Prevail (K073285) RSB InterPlate C-P (K092070) Device Description: The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion de… | 2009 |
What descends from it? (33)
See all 333 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2013 | Class II | Z-0455-2014 | Process design | A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 5 of the 48 ancestors have a recall of any class.
- Of its descendants, K121852 (Synthes Spine Co.Lp, 2012) has gone furthest, with 30 descendants of its own.
- 13 other devices also cite its predicate K072981.
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. 2011, 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-TI. DDD 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/K112068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112068: 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/K112068
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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