510(k) · Cleared
ClearedNuVasive® CoRoent® Small Interlock™ 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 Sep 28, 2016 as substantially equivalent to K142299 (Nu Vasive, Incorporated, 2014) and 4 other predicates after a 126-day review. Its family tree reaches back 15 generations to 1984. 94 later devices descend from it.
- Decided
- Sep 28, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K841189 (1984). 130 ancestors in all, the oldest K792352 (1979). 94 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 1 generation backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- This deviceK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- Descendant · 2 generations on · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
- Descendant · 2 generations on · 25 of its ownK190885 Elevation Spine Saber-C SystemElevation Spine · 2019
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 1 generation backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- This deviceK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · cites it directly83descendants
- K180909REVEL SpacersGlobus Medical, Inc. · 2018 · 2 generations on37descendants
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · 2 generations on36descendants
- K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · 2 generations on25descendants
- K190885Elevation Spine Saber-C SystemElevation Spine · 2019 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −2 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −1 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| 0 (this device) | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +2 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| +2 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| +2 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | — |
| +2 | K190885 | Elevation Spine Saber-C System | Elevation Spine | 2019 | — |
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 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 7 | 0 |
| 2004 | 17 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 16 | 0 |
| 2009 | 7 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 13 | 0 |
| 2024 | 17 | 0 |
| 2025 | 24 | 0 |
| 2026 | 17 | 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? (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 |
|---|---|---|---|
| * | K142299 | CoRoent Small Interlock SystemSummary page 4…Devices The subject NuVasive CoRoent Small Interlock System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K142299) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547) is an additional predicate d… | 2014 |
| * | K102547 | Coroent Interlock SystemSummary page 4…multiple predicate devices. NuVasive CoRoent Small Interlock System (K142299) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547) is an additional predicate device. NuVasive CoRoent Small Interbody System (K140921), NuVasive CoRoent System (K081611… | 2011 |
| * | K140921 | Coroent Small Interbody SystemSummary page 4…as the primary predicate device, while NuVasive CoRoent Interlock System (K102547) is an additional predicate device. NuVasive CoRoent Small Interbody System (K140921), NuVasive CoRoent System (K081611) and NuVasive Archon Anterior Cervical System (K131025) are additional predicate dev… | 2014 |
| * | K081611 | Nuvasive Coroent SystemSummary page 4…hile NuVasive CoRoent Interlock System (K102547) is an additional predicate device. NuVasive CoRoent Small Interbody System (K140921), NuVasive CoRoent System (K081611) and NuVasive Archon Anterior Cervical System (K131025) are additional predicate devices. D. Device Description The… | 2008 |
| * | K131025 | Archon Anterior Cervical Plate SystemSummary page 4…additional predicate device. NuVasive CoRoent Small Interbody System (K140921), NuVasive CoRoent System (K081611) and NuVasive Archon Anterior Cervical System (K131025) are additional predicate devices. D. Device Description The NuVasive CoRoent Small Interlock System is a standalone ante… | 2013 |
What descends from it? (94)
See all 942 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 32 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 17 of the 130 ancestors have a recall of any class.
- Of its descendants, K173115 (Globus Medical, Inc., 2017) has gone furthest, with 83 descendants of its own.
- 2 other devices also cite its predicate K142299.
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. 2016, 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 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 NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended…
Read the full statement (111 words)
The NuVasive CoRoent Small Interlock 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 NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock 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 as stated in the FDA summary.
https://510kreport.com/device/K161442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161442: NuVasive® CoRoent® Small Interlock™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161442
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