510(k) · Cleared
ClearedNuVasive CoRoent Small Interlock II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jun 8, 2017 as substantially equivalent to K161442 (Nu Vasive, Incorporated, 2016) and 5 other predicates after a 69-day review. Its family tree reaches back 20 generations to 1984. 18 later devices descend from it.
- Decided
- Jun 8, 2017
- Review
- 69 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 20 generations to K841189 (1984). 256 ancestors in all, the oldest K792352 (1979). 18 later devices descend from it, 2 citing it directly.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- 1 generation backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
- This deviceK170961 NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · cites it directly · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 3 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 2 generations on · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- 1 generation backK162138 NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated · 2016
- This deviceK170961 NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · cites it directly9descendants
- K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · cites it directly7descendants
- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on6descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 3 generations on5descendants
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K160916 | CoRoent® Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K162138 | NuVasive CoRoent Small Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K170961 | NuVasive CoRoent Small Interlock II System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +1 | K181621 | Stable-C Interbody System | Nexus Spine, LLC | 2018 | — |
| +2 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +3 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +2 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 13 | 0 |
| 2004 | 21 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 14 | 0 |
| 2008 | 37 | 0 |
| 2009 | 21 | 0 |
| 2010 | 14 | 0 |
| 2011 | 14 | 0 |
| 2012 | 8 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K161442 | NuVasive® CoRoent® Small Interlock™ SystemSummary page 4…E C. Predicate Devices The subject CoRoent Small Interlock II System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K161442) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547), NuVasive CoRoent Interlock System (K1… | 2016 |
| * | K102547 | Coroent Interlock SystemSummary page 4…ivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K161442) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547), NuVasive CoRoent Interlock System (K142299), NuVasive CoRoent Ti-C System (K163707), NuVasive CoRoent Small Ti-C System (K16213… | 2011 |
| * | K142299 | CoRoent Small Interlock SystemSummary page 4…ve CoRoent Small Interlock System (K161442) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547), NuVasive CoRoent Interlock System (K142299), NuVasive CoRoent Ti-C System (K163707), NuVasive CoRoent Small Ti-C System (K162138), and NuVasive CoRoent System (K081611) are… | 2014 |
| * | K163707 | NuVasive CoRoent Ti-C System Cleared while this submission was under review Summary page 4…42) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547), NuVasive CoRoent Interlock System (K142299), NuVasive CoRoent Ti-C System (K163707), NuVasive CoRoent Small Ti-C System (K162138), and NuVasive CoRoent System (K081611) are additional predicate devices. D. Devic… | 2017 |
| * | K162138 | NuVasive CoRoent Small Ti-C SystemSummary page 4…ile NuVasive CoRoent Interlock System (K102547), NuVasive CoRoent Interlock System (K142299), NuVasive CoRoent Ti-C System (K163707), NuVasive CoRoent Small Ti-C System (K162138), and NuVasive CoRoent System (K081611) are additional predicate devices. D. Device Description The NuVasive CoRoent Small Inte… | 2016 |
| * | K081611 | Nuvasive Coroent SystemSummary page 4…K102547), NuVasive CoRoent Interlock System (K142299), NuVasive CoRoent Ti-C System (K163707), NuVasive CoRoent Small Ti-C System (K162138), and NuVasive CoRoent System (K081611) are additional predicate devices. D. Device Description The NuVasive CoRoent Small Interlock Il System is an anterior cervical… | 2008 |
What descends from it? (18)
See all 182 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 33 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 27 of the 256 ancestors have a recall of any class.
- Of its descendants, K231735 (Nu Vasive, Incorporated, 2023) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K161442.
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. 2017, 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 NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least 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/K170961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170961: NuVasive CoRoent Small Interlock II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170961
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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