510(k) · Cleared
ClearedNuvasive Coroent NO-Profile System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 13, 2012 as substantially equivalent to K100043 (Nuvasive, Inc., 2010) and 5 other predicates after a 193-day review. Its family tree reaches back 13 generations to 1984. 12 later devices descend from it.
- Decided
- Mar 13, 2012
- Review
- 193 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K841189 (1984). 71 ancestors in all. 12 later devices descend from it, 1 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 backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- This deviceK112561 Nuvasive Coroent NO-Profile SystemNuvasive, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 2 generations on · 9 of its ownK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · 3 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · 4 generations on · 3 of its ownK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
- Descendant · 4 generations on · 2 of its ownK233594 Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023
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 backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- This deviceK112561 Nuvasive Coroent NO-Profile SystemNuvasive, Inc. · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016 · cites it directly11descendants
- K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019 · 2 generations on9descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 3 generations on7descendants
- K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022 · 4 generations on3descendants
- K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023 · 4 generations on2descendants
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 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| 0 (this device) | K112561 | Nuvasive Coroent NO-Profile System | Nuvasive, Inc. | 2012 | — |
| +1 | K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Genesys Spine | 2016 | — |
| +2 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +3 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +4 | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | — |
| +4 | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K100043 | Coroent XLR Standalone SystemSummary page 1…icate Devices The subject NuVasive CoRoent No-Profile System is substantially equivalent to the following device: 510(k) Number Product Name, K100043 NuVasive CoRoent XLR Standalone System K102090 SpineSmith.Cynch Spinal System - Visualif Interbody… | 2010 |
| * | K102090 | Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSummary page 1…em is substantially equivalent to the following device: 510(k) Number Product Name, K100043 NuVasive CoRoent XLR Standalone System K102090 SpineSmith.Cynch Spinal System - Visualif Interbody Fusion ____________Implant System… | 2010 |
| * | K041617 | Stalif TTSummary page 1…andalone System K102090 SpineSmith.Cynch Spinal System - Visualif Interbody Fusion ____________Implant System K0416 17, K073 109 SurgiCraft STALIFTM TT Intervertebral Body Fusion System K09 1301 Lif… | 2004 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…K102090 SpineSmith.Cynch Spinal System - Visualif Interbody Fusion ____________Implant System K0416 17, K073 109 SurgiCraft STALIFTM TT Intervertebral Body Fusion System K09 1301 Life Spine® Stand-Alone S… | 2008 |
| * | K091301 | Life Spine Stand-Alone Spacer SystemSummary page 1…____________Implant System K0416 17, K073 109 SurgiCraft STALIFTM TT Intervertebral Body Fusion System K09 1301 Life Spine® Stand-Alone Spacer System (Dyna-Link®) F K082252 Globus Medical Independence® Sp… | 2009 |
| * | K082252 | Independence SpacerSummary page 1…09 SurgiCraft STALIFTM TT Intervertebral Body Fusion System K09 1301 Life Spine® Stand-Alone Spacer System (Dyna-Link®) F K082252 Globus Medical Independence® Spacer D. Device Description The NuVasive CoRoent No-Profile Standalone System… | 2008 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | 2016 | 11 |
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 28 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 71 ancestors have a recall of any class.
- Of its descendants, K161438 (Genesys Spine, 2016) has gone furthest, with 11 descendants of its own.
- 10 other devices also cite its predicate K100043.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. ODD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.…
Read the full statement (120 words)
The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. ODD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112561: Nuvasive Coroent NO-Profile System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112561
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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