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 Nov 13, 2019 as substantially equivalent to K142299 (Nu Vasive, Incorporated, 2014) and 2 other predicates after a 55-day review. Its family tree reaches back 15 generations to 1984. 30 later devices descend from it.
- Decided
- Nov 13, 2019
- Review
- 55 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 119 ancestors in all, the oldest K792352 (1979). 30 later devices descend from it, 5 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 deviceK192582 NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated · 2019
- Descendant · cites it directly · 15 of its ownK212904 SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · cites it directly · 13 of its ownK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
- Descendant · cites it directly · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · 2 generations on · 8 of its ownK233414 Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation · 2023
- Descendant · cites it directly · 7 of its ownK213359 SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation · 2021
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 deviceK192582 NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated · 2019
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021 · cites it directly15descendants
- K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc. · 2022 · cites it directly13descendants
- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · cites it directly9descendants
- K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation · 2023 · 2 generations on8descendants
- K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation · 2021 · cites it directly7descendants
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) | K192582 | NuVasive CoRoent Small Interlock System | Nu Vasive, Incorporated | 2019 | — |
| +1 | K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| +1 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti… | Alphatec Spine, Inc. | 2022 | — |
| +1 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +2 | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | 2023 | — |
| +1 | K213359 | SeaSpine WaveForm, C Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
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 | 5 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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? (3)
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…redicate Devices The subject CoRoent Small Interlock System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K142299) serves as the primary predicate device, the NuVasive CoRoent Small Interbody System (K163491) and the Centinel Spine S… | 2014 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 4…tiple predicate devices. NuVasive CoRoent Small Interlock System (K142299) serves as the primary predicate device, the NuVasive CoRoent Small Interbody System (K163491) and the Centinel Spine STALIF C and STALIF C-Ti (K150053) serve as additional predicates, and NuVasive Archon Anterior… | 2017 |
| * | K150053 | STALIF C; STALIF C-TiSummary page 4…System (K142299) serves as the primary predicate device, the NuVasive CoRoent Small Interbody System (K163491) and the Centinel Spine STALIF C and STALIF C-Ti (K150053) serve as additional predicates, and NuVasive Archon Anterior Cervical Plate System (K131025) serves as a reference predicat… | 2015 |
| † | K131025 | Archon Anterior Cervical Plate System | 2013 |
What descends from it? (30)
See all 305 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212904 | SeaSpine WaveForm C Interbody System | 2021 | 15 |
| K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System… | 2022 | 13 |
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody… | 2023 | 9 |
| K213359 | SeaSpine WaveForm, C Interbody System | 2021 | 7 |
| K263049 | SABER-C System | 2026 | 0 |
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 35 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 14 of the 119 ancestors have a recall of any class.
- Of its descendants, K212904 (SeaSpine Orthopedics Corporation, 2021) has gone furthest, with 15 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. 2019, 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 standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The System is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192582 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192582: NuVasive CoRoent Small Interlock System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192582
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