510(k) · Cleared
ClearedSOVEREIGN® Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 14, 2016 as substantially equivalent to K121982 (Medtronic Sofamor Danek, 2012) and 1 other predicate after a 79-day review. Its family tree reaches back 16 generations to 2001. 31 later devices descend from it.
- Decided
- Dec 14, 2016
- Review
- 79 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K003155 (2001). 157 ancestors in all, the oldest K792352 (1979). 31 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 2 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 1 generation backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK162680 SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · cites it directly · 30 of its ownK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- Descendant · 2 generations on · 21 of its ownK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · 4 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 5 generations on · 5 of its ownK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 6 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 5 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 3 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 2 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 1 generation backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK162680 SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017 · cites it directly30descendants
- K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on21descendants
- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · 3 generations on20descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 4 generations on17descendants
- K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc. · 2024 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −6 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −5 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −3 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −2 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −1 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| 0 (this device) | K162680 | SOVEREIGN® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +1 | K172328 | SOVEREIGN™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +2 | K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +4 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +5 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
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 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 19 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 22 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 9 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K121982 | Sovereign Spinal SystemSummary page 4…x 21 CFR 888.3080 Intervertebral Body Fusion Device; Regulation Name, and OVD Device Product Code K121982 SOVEREIGN® Spinal System (S.E. 07/06/2012) – Primary Predicate Predicate Devices K150135 DIVERGE… | 2012 |
| * | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemSummary page 4…VD Device Product Code K121982 SOVEREIGN® Spinal System (S.E. 07/06/2012) – Primary Predicate Predicate Devices K150135 DIVERGENCE-L™ Anterior Oblique Lumbar Fusion System (S.E. 06/11/2015) The pre… | 2015 |
What descends from it? (31)
See all 312 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 15 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 157 ancestors have a recall of any class.
- Of its descendants, K172328 (Medtronic Sofamor Danek USA, Inc., 2017) has gone furthest, with 30 descendants of its own.
- 3 other devices also cite its predicate K121982.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive…
Read the full statement (169 words)
The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.
The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162680: SOVEREIGN® Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162680
Report an extraction error
Are you the manufacturer?
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