510(k) · Cleared
ClearedOptio-C Anterior Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 16, 2014 as substantially equivalent to K103033 (Zimmer Trabecular Metal Technology, 2011) and 4 other predicates after a 122-day review. Its family tree reaches back 14 generations to 2001. 24 later devices descend from it.
- Decided
- Jan 16, 2014
- Review
- 122 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K003155 (2001). 92 ancestors in all, the oldest K792352 (1979). 24 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK112388 Lanx Cervical SALanx, Inc. · 2011
- This deviceK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
- Descendant · cites it directly · 21 of its ownK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
- Descendant · 2 generations on · 19 of its ownK200115 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020
- Descendant · 2 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
- Descendant · 2 generations on · 5 of its ownK223105 Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · 3 generations on · 5 of its ownK223190 Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK112388 Lanx Cervical SALanx, Inc. · 2011
- This deviceK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018 · cites it directly21descendants
- K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020 · 2 generations on19descendants
- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 2 generations on18descendants
- K223105Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022 · 2 generations on5descendants
- K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K094042 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek | 2010 | — |
| −1 | K112388 | Lanx Cervical SA | Lanx, Inc. | 2011 | — |
| 0 (this device) | K132894 | Optio-C Anterior Cervical System | Zimmer Spine, Inc. | 2014 | — |
| +1 | K173077 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2018 | — |
| +2 | K200115 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2020 | — |
| +2 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
| +2 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +3 | K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 15 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K091898 | FDA’s K091898 is Blood Glucose Monitoring System, Model Fora G90/TD-4234 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K103033 | Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxSummary page 2…ClaeNo1,21 8 21 ODP K103033 (TM-S) Met Traecla MtaWTrabcula OP Cleared Jan 10,… | 2011 |
| * | K111119 | Trabecular Metal (TM) Fusion DeviceSummary page 2…Traecla MtaWTrabcula OP Cleared Jan 10, 2011 Zimmer Trabecular Metal 2188.308 K111119 _________________§__888.3080__ C… | 2011 |
| * | K073351 | CrystalSummary page 2…Cleared Nov 23, 2011 Crystal® ODP, MOP K073351 Spinal Elements, Inc. 21 CFR Cleared Jan 24, 2008… | 2008 |
| * | K112388 | Lanx Cervical SASummary page 2….3080 __________ Lanx Cervical SA System OVE La21Ic.§ CFR. K112388 Lan, 888.3080 Cleared Dec 16, 2011 HONOUR Spacer System… | 2011 |
| * | K120345 | Honour Spacer SystemSummary page 2…Lan, 888.3080 Cleared Dec 16, 2011 HONOUR Spacer System 21 CE K120345 NEXXT Spine 288.380 Cleared June 13, 2012 General Device Description:… | 2012 |
| * | — | PEEK PREVAIL Cervical Interbody Named without a submission number |
What descends from it? (24)
See all 243 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 13 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 5 of the 92 ancestors have a recall of any class.
- Of its descendants, K173077 (Neurostructures, Inc., 2018) has gone furthest, with 21 descendants of its own.
- 7 other devices also cite its predicate K103033.
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. 2014, 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 Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD) is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.
The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132894 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132894: Optio-C Anterior Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132894
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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