510(k) · Cleared
ClearedCoRoent 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 Nov 25, 2014 as substantially equivalent to K140921 (Nu Vasive, Incorporated, 2014) and 1 other predicate after a 99-day review. Its family tree reaches back 14 generations to 1984. 99 later devices descend from it.
- Decided
- Nov 25, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K841189 (1984). 112 ancestors in all, the oldest K792352 (1979). 99 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- This deviceK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · 3 generations on · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- Descendant · 3 generations on · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 30 of its ownK192582 NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated · 2019
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 4 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- This deviceK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · cites it directly94descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 2 generations on83descendants
- K180909REVEL SpacersGlobus Medical, Inc. · 2018 · 3 generations on37descendants
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · 3 generations on36descendants
- K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated · 2019 · cites it directly30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −4 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −3 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −1 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| 0 (this device) | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +3 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| +3 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K192582 | NuVasive CoRoent Small Interlock System | Nu Vasive, Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 17 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 16 | 0 |
| 2009 | 7 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 18 | 0 |
| 2025 | 24 | 0 |
| 2026 | 18 | 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? (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 |
|---|---|---|---|
| * | K140921 | Coroent Small Interbody SystemSummary page 4…redicate Devices The subject CoRoent Small Interlock System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interbody System (K140921) serves as the primary predicate device, while NuVasive CoRoent Small Interlock System (K102547) is an additional predi… | 2014 |
| * | K102547 | Coroent Interlock SystemSummary page 4…ple predicate devices. NuVasive CoRoent Small Interbody System (K140921) serves as the primary predicate device, while NuVasive CoRoent Small Interlock System (K102547) is an additional predicate device. SeaSpine Inc. Zuma-C (K092521) and Zimmer Spine Optio-C Anterior Cervical System (K… | 2011 |
| † | K092521 | ZUMA-C | 2010 |
| † | K132894 | Optio-C Anterior Cervical System | 2014 |
What descends from it? (99)
See all 993 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 30 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 14 of the 112 ancestors have a recall of any class.
- Of its descendants, K161442 (Nu Vasive, Incorporated, 2016) has gone furthest, with 94 descendants of its own.
- 2 other devices also cite its predicate K140921.
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. 2014, 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 CoRoent® Small Interlock System is a stand-alone 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
System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or
corticocancellous bone graft to faciliate 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/K142299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142299: CoRoent Small Interlock System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142299
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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