510(k) · Cleared
ClearedCoroent Interlock System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Feb 7, 2011 as substantially equivalent to K072415 (Surgicraft, Ltd., 2008) and 5 other predicates after a 157-day review. Its family tree reaches back 13 generations to 1984. 131 later devices descend from it.
- Decided
- Feb 7, 2011
- Review
- 157 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K841189 (1984). 92 ancestors in all, the oldest K792352 (1979). 131 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- This deviceK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- Descendant · cites it directly · 99 of its ownK142299 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
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- This deviceK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
Showing 5 of 131 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 131 · See all- K142299CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014 · cites it directly99descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −1 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| 0 (this device) | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| +1 | 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 | — |
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 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 15 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 9 | 0 |
| 2022 | 13 | 0 |
| 2023 | 17 | 0 |
| 2024 | 20 | 0 |
| 2025 | 27 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K072415 | Stalif (TM) CSummary page 1…080 Product Code: ODP C. Predicate Devices The subject CoRoent Small Interlock System is substantially equivalent to the following devices previously cleared by FDA: o K072415 - Surgicraft Limited STALIF™ C K072981- Synthes Spine Synthes Zero-P K083389 — Globus Medical Coalition™ Spacer K094042—- Medtron… | 2008 |
| * | K072981 | Synthes Zero-PSummary page 1…vices The subject CoRoent Small Interlock System is substantially equivalent to the following devices previously cleared by FDA: o K072415 - Surgicraft Limited STALIF™ C K072981- Synthes Spine Synthes Zero-P K083389 — Globus Medical Coalition™ Spacer K094042—- Medtronic Sofamor Danek PEEK PREVAIL™ Cervical… | 2008 |
| * | K083389 | Coalition SpacerSummary page 1…ock System is substantially equivalent to the following devices previously cleared by FDA: o K072415 - Surgicraft Limited STALIF™ C K072981- Synthes Spine Synthes Zero-P K083389 — Globus Medical Coalition™ Spacer K094042—- Medtronic Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device K092521- SeaSpine, I… | 2009 |
| * | K094042 | Peek Prevail Cervical Interbody DeviceSummary page 1…he following devices previously cleared by FDA: o K072415 - Surgicraft Limited STALIF™ C K072981- Synthes Spine Synthes Zero-P K083389 — Globus Medical Coalition™ Spacer K094042—- Medtronic Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device K092521- SeaSpine, Inc. Zuma-C™ e K100043- NuVasive, Inc. CoRoe… | 2010 |
| * | K092521 | ZUMA-CSummary page 1…ited STALIF™ C K072981- Synthes Spine Synthes Zero-P K083389 — Globus Medical Coalition™ Spacer K094042—- Medtronic Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device K092521- SeaSpine, Inc. Zuma-C™ e K100043- NuVasive, Inc. CoRoent XLR Standalone System D. Device Description The NuVasive CoRoent Smal… | 2010 |
| * | K100043 | Coroent XLR Standalone SystemSummary page 1…ine Synthes Zero-P K083389 — Globus Medical Coalition™ Spacer K094042—- Medtronic Sofamor Danek PEEK PREVAIL™ Cervical Interbody Device K092521- SeaSpine, Inc. Zuma-C™ e K100043- NuVasive, Inc. CoRoent XLR Standalone System D. Device Description The NuVasive CoRoent Small Interlock System is a standalone… | 2010 |
What descends from it? (131)
See all 1315 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142299 | CoRoent Small Interlock System | 2014 | 99 |
| K161442 | NuVasive® CoRoent® Small Interlock™ System | 2016 | 94 |
| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | 2016 | 32 |
| K131429 | Reliance Cervical Ibf System | 2013 | 24 |
| K170961 | NuVasive CoRoent Small Interlock II System | 2017 | 18 |
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 27 years and passes through 11 companies; a new generation was cleared every 9 months on median.
- 10 of the 92 ancestors have a recall of any class.
- Of its descendants, K142299 (Nu Vasive, Incorporated, 2014) has gone furthest, with 99 descendants of its own.
- 12 other devices also cite its predicate K072415.
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. 2011, 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 degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.
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/K102547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102547: Coroent 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/K102547
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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