510(k) · Cleared
ClearedPeek Prevail Cervical Interbody Device
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 May 15, 2008 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 3 other predicates after a 174-day review. Its family tree reaches back 11 generations to 2001. 1 of the 667 devices in its family, counting itself, has a Class I recall. 637 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 174 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K003155 (2001). 29 ancestors in all, the oldest K792352 (1979). 637 later devices descend from it, 14 citing it directly. 1 of the 667 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations between
- 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 1 generation backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- This deviceK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · cites it directly · 397 of its ownK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- Descendant · 2 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- Descendant · cites it directly · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 324 of its ownK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
Show all 11 generations
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations backK012254 VBROsteotech, Inc. · 2001
- 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 6 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 1 generation backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- This deviceK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
Showing 5 of 637 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 637 · See all- K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010 · cites it directly397descendants
- K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · cites it directly389descendants
- K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 2 generations on331descendants
- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · cites it directly330descendants
- K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 2 generations on324descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −10 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −9 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −6 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −2 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −1 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| 0 (this device) | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +1 | K094042 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek | 2010 | — |
| +1 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| +2 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| +1 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +2 | K112444 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 24 | 0 |
| 2017 | 39 | 0 |
| 2018 | 31 | 0 |
| 2019 | 43 | 0 |
| 2020 | 58 | 0 |
| 2021 | 62 | 1 |
| 2022 | 61 | 0 |
| 2023 | 74 | 0 |
| 2024 | 72 | 0 |
| 2025 | 66 | 0 |
| 2026 | 64 | 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.
1 device in this family has a Class I recall. 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? (5)
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 | P000028 | FDA’s P000028 is Affinity (TM) Cage System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 2…eviously approved devices such as the previously approved AFFINITY® Antcrior Cervical Cage (P00C028, Approved - 06/13/2002), the BAK/C® Cervical Interbody Fuston System (P980048, Approved — 04/20/2001), VERTE-STACK® Spinal System (K070173, S.E. 3-14-2007 and K062073, S.E. 8-14-2007), and the VENTURE™ Anter… | 2001 |
| * | K070173 | Verte-Stack Spinal SystemSummary page 2…INITY® Antcrior Cervical Cage (P00C028, Approved - 06/13/2002), the BAK/C® Cervical Interbody Fuston System (P980048, Approved — 04/20/2001), VERTE-STACK® Spinal System (K070173, S.E. 3-14-2007 and K062073, S.E. 8-14-2007), and the VENTURE™ Anterior Cervical Plate System (K061274, S.E. 05-25-2006). === Pa… | 2007 |
| * | K062073 | Verte-Stack Spinal SystemSummary page 2…e (P00C028, Approved - 06/13/2002), the BAK/C® Cervical Interbody Fuston System (P980048, Approved — 04/20/2001), VERTE-STACK® Spinal System (K070173, S.E. 3-14-2007 and K062073, S.E. 8-14-2007), and the VENTURE™ Anterior Cervical Plate System (K061274, S.E. 05-25-2006). WiALTy oo 44 VI pe… | 2006 |
| * | K061274 | Venture Anterior Cervical Plate SystemSummary page 2…stem (P980048, Approved — 04/20/2001), VERTE-STACK® Spinal System (K070173, S.E. 3-14-2007 and K062073, S.E. 8-14-2007), and the VENTURE™ Anterior Cervical Plate System (K061274, S.E. 05-25-2006). WiALTy oo 44 VI pestvcEs Y, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service “… | 2006 |
What descends from it? (637)
See all 63714 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K094042 | Peek Prevail Cervical Interbody Device | 2010 | 397 |
| K100214 | Cornerstone PSR Cervical Interbody Fusion Device | 2010 | 389 |
| K133494 | Chesapeake Spinal System | 2014 | 330 |
| K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail… | 2013 | 281 |
| K112459 | Synthes Zero-P | 2011 | 277 |
| K120275 | Synthes Acis/Vertebral Spacer CR | 2012 | 173 |
| K142218 | Coalition AGX Plate and Coalition AGX Spacer | 2015 | 155 |
| K100967 | Perimeter C Spinal System | 2011 | 121 |
| K142940 | Endoskeleton TCS System | 2015 | 111 |
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical… | 2016 | 110 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K094042 (Medtronic Sofamor Danek, 2010) has gone furthest, with 397 descendants of its own.
- 53 other devices also cite its predicate P980048.
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. 2008, 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 PEEK PREVAIL™ Cervical Interbody Device is indicated for 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…
Read the full statement (121 words)
The PEEK PREVAIL™ Cervical Interbody Device is indicated for 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 PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws, The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K073285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073285: Peek Prevail Cervical Interbody Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073285
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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