510(k) · Cleared
ClearedDivergence Anterior Cervical Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 21, 2015 as substantially equivalent to K113252 (Medtronic Sofamor Danek, 2012) and 6 other predicates after a 222-day review. Its family tree reaches back 14 generations to 2001. 16 later devices descend from it.
- Decided
- Jan 21, 2015
- Review
- 222 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K003155 (2001). 105 ancestors in all, the oldest K792352 (1979). 16 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 backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- This deviceK141599 Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK182885 Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK212358 Romero Cervical CageSpineup, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK240893 ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024
- Descendant · cites it directly · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
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 backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- This deviceK141599 Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc. · 2019 · cites it directly8descendants
- K212358Romero Cervical CageSpineup, Inc. · 2022 · cites it directly6descendants
- K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024 · 2 generations on4descendants
- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · cites it directly4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 2 generations on2descendants
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 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −1 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| 0 (this device) | K141599 | Divergence Anterior Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +1 | K212358 | Romero Cervical Cage | Spineup, Inc. | 2022 | — |
| +2 | K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024 | — |
| +1 | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +2 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 16 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K113252 | Peek Prevail Cervical Interbody DeviceSummary page 4…ss II Product Codes OVE Primary Predicate PEEK PREVAIL® Cervical Interbody Device (K113252, SE 01/17/2012) Secondary Predicates •CORNERSTONE® PSR Cervical Fusion… | 2012 |
| * | K094042 | Peek Prevail Cervical Interbody DeviceSummary page 7…K141599 - Page 4 of 4 • PEEK PREVAIL® Cervical Interbody Device (K113252, SE 01/17/2012; K094042, SE 06/30/2010) • CORNERSTONE® PSR Cervical Fusion System (K111264, SE 10/12/2011; K100214, SE 06/25/2010)… | 2010 |
| * | K111264 | Cornerstone (R) PSR Cervical Fusion SystemSummary page 4…Device (K113252, SE 01/17/2012) Secondary Predicates •CORNERSTONE® PSR Cervical Fusion System (K111264; K100214) •AFFINITY® Anterior Cervical Cage System… | 2011 |
| * | K100214 | Cornerstone PSR Cervical Interbody Fusion DeviceSummary page 4…Device (K113252, SE 01/17/2012) Secondary Predicates •CORNERSTONE® PSR Cervical Fusion System (K111264; K100214) •AFFINITY® Anterior Cervical Cage System (P000028,… | 2010 |
| * | P000028 | Affinity (TM) Cage SystemSummary page 4…Fusion System (K111264; K100214) •AFFINITY® Anterior Cervical Cage System (P000028, down-classified to Class II special controls, Date of Final… | 2002 |
| * | K030327 | Zephir Anterior Cervical SystemSummary page 4…Order 06/12/2007) •ZEPHIR® Anterior Cervical System (K030327) •ATLANTIS® Anterior Cervical Plate… | 2003 |
| * | K130640 | Atlantis Anterior Cervical Plate SystemSummary page 5…Page 5 === K141599 - Page 2 of 4 System (K130640) VI. Product Description The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody f… | 2013 |
What descends from it? (16)
See all 163 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 14 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 10 of the 105 ancestors have a recall of any class.
- Of its descendants, K182885 (Medtronic Sofamor Danek USA, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K113252.
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. 2015, 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 DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve…
Read the full statement (143 words)
The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141599: Divergence Anterior Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141599
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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