510(k) · Cleared
ClearedStable-L Standalone Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexus Spine, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 18, 2022 as substantially equivalent to K203201 (Nu Vasive, Incorporated, 2021) and 6 other predicates after a 221-day review. Its family tree reaches back 25 generations to 1984. 1 of the 484 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Mar 18, 2022
- Review
- 221 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 25 generations to K841189 (1984). 476 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 2 citing it directly. 1 of the 484 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203201 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2021
- This deviceK212498 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022
- Descendant · cites it directly · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 2 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · cites it directly · 1 of its ownK231486 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203201 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2021
- This deviceK212498 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 7 · See all- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · cites it directly5descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on2descendants
- K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2023 · cites it directly1descendant
- K261279DeltaNEC Interbody SystemNexus Spine · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −2 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −1 | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2021 | — |
| 0 (this device) | K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2022 | — |
| +1 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +2 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +2 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +1 | K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2023 | — |
| +3 | K261279 | DeltaNEC Interbody System | Nexus Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 22 | 0 |
| 2004 | 40 | 0 |
| 2005 | 27 | 0 |
| 2006 | 15 | 0 |
| 2007 | 20 | 0 |
| 2008 | 51 | 1 |
| 2009 | 38 | 0 |
| 2010 | 26 | 0 |
| 2011 | 35 | 0 |
| 2012 | 25 | 0 |
| 2013 | 29 | 0 |
| 2014 | 23 | 0 |
| 2015 | 23 | 0 |
| 2016 | 14 | 0 |
| 2017 | 11 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Summary page 4…Device 510(k) Number Primary Predicate NuVasive, Incorporated Brigade Standalone System K203201 Additional Predicates Globus Medical Independence MIS Anterior Lumbar K203278… | 2021 |
| * | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Summary page 4…Incorporated Brigade Standalone System K203201 Additional Predicates Globus Medical Independence MIS Anterior Lumbar K203278 Interbody Fusion System Nexus Spine, LLC Tranquil-L Interbody System… | 2021 |
| * | K181702 | Tranquil-L Interbody SystemSummary page 4…MIS Anterior Lumbar K203278 Interbody Fusion System Nexus Spine, LLC Tranquil-L Interbody System K181702 Synthes USA Products, SYNFIX Evolution System K162358 LLC Centinel Spine… | 2018 |
| * | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSummary page 4…sion System Nexus Spine, LLC Tranquil-L Interbody System K181702 Synthes USA Products, SYNFIX Evolution System K162358 LLC Centinel Spine STALIF Midline K101301 Centinel Spine… | 2016 |
| * | K101301 | Stalif MidlineSummary page 4…Synthes USA Products, SYNFIX Evolution System K162358 LLC Centinel Spine STALIF Midline K101301 Centinel Spine STALIF TT K073109 Theken Spine Vu aPOD… | 2010 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 4…LLC Centinel Spine STALIF Midline K101301 Centinel Spine STALIF TT K073109 Theken Spine Vu aPOD K101310 Device Description: The Stable-L™… | 2008 |
| * | K101310 | VU Apod Intervertebral Body Fusion DeviceSummary page 4…K101301 Centinel Spine STALIF TT K073109 Theken Spine Vu aPOD K101310 Device Description: The Stable-L™ Standalone Interbody System is made of Ti-6Al-4V. The… | 2010 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 48 of the 476 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232530 (Nexus Spine, LLC, 2023) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K203201.
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. 2022, 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 Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two…
Read the full statement (181 words)
The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212498: Stable-L Standalone Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212498
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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