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 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jul 26, 2012 as substantially equivalent to K091813 (Medtronic Sofamor Danek, 2009) and 4 other predicates after a 20-day review. Its family tree reaches back 13 generations to 1984. 155 later devices descend from it.
- Decided
- Jul 26, 2012
- Review
- 20 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K841189 (1984). 67 ancestors in all. 155 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
- 1 generation backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- This deviceK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
- Descendant · cites it directly · 146 of its ownK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
- Descendant · cites it directly · 137 of its ownK150673 SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015
- Descendant · 2 generations on · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- Descendant · 3 generations on · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
- Descendant · 4 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
- 1 generation backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- This deviceK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
Showing 5 of 155 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 155 · See all- K131276Lateral SynfixSynthes (USA) Products, LLC · 2014 · cites it directly146descendants
- K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015 · cites it directly137descendants
- K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · 2 generations on127descendants
- K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · 3 generations on109descendants
- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on108descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −2 | K111525 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2011 | — |
| −1 | K113642 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek USA | 2012 | — |
| 0 (this device) | K121982 | Sovereign Spinal System | Medtronic Sofamor Danek | 2012 | — |
| +1 | K131276 | Lateral Synfix | Synthes (USA) Products, LLC | 2014 | — |
| +1 | K150673 | SYNFIX Evolution Secured Spacer System | Synthes (USA) Products, LLC | 2015 | — |
| +2 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016 | — |
| +3 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +4 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 17 | 0 |
| 2023 | 15 | 0 |
| 2024 | 30 | 0 |
| 2025 | 26 | 0 |
| 2026 | 29 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091813 | Intrepid Spinal SystemSummary page 3…ed to Claim Substantial Equivalence In order to demonstrate substantial equivalence to legally marketed predicate devices, SOVEREIGNS Spinal System (K0918 13, SE Nov 17, 2009, and KI 110063, SE Oct 4, 2011) is used as the primary predicate for intended use and fundamental scienti… | 2009 |
| * | K110063 | Sovereign Spinal SystemSummary page 3…al System to be substantially equivalent to legally marketed predicate devices, including the previously cleared SOVEREIGN® Spinal System (K091 813, SE Nov 17, 2009, and K 110063, SE Oct 4, 2011). ?_5 -3of 3 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2011 |
| * | K120368 | Capstone Control Spinal SystemSummary page 3…l predicates are being used to support the instrument sterilization and cleaning rationale included in this submission: " CAPSTONE CONTROLTM Spinal System (K120368, SE April 9, 2012), * PERIMETER® Interbody Fusion Device (KI 13642, SE Feb 6, 2012), and * TELAMON® PEEK Spinal Sys… | 2012 |
| * | K113642 | Perimeter Interbody Fusion Device | 2012 |
| * | K110562 | Telamon Peek Spinal System | 2011 |
What descends from it? (155)
See all 1554 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 28 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 67 ancestors have a recall of any class.
- Of its descendants, K131276 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 146 descendants of its own.
- 7 other devices also cite its predicate K091813.
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. 2012, 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 six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior…
Read the full statement (166 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 six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.
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 the three 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 three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121982: 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/K121982
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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