510(k) · Cleared
ClearedCoroent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 20, 2014 as substantially equivalent to K123027 (Medtronic Sofamor Danek, Inc., 2013) and 4 other predicates after a 129-day review. Its family tree reaches back 14 generations to 1984. 480 later devices descend from it.
- Decided
- Nov 20, 2014
- Review
- 129 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K841189 (1984). 78 ancestors in all. 480 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK141896 Coroent SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 304 of its ownK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
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 backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK141896 Coroent SystemNu Vasive, Incorporated · 2014
Showing 5 of 480 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 480 · See all- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · cites it directly479descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 2 generations on400descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 3 generations on396descendants
- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · cites it directly381descendants
- K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017 · 2 generations on304descendants
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 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −2 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −1 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| 0 (this device) | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
| +3 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +2 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 13 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 18 | 0 |
| 2018 | 23 | 0 |
| 2019 | 31 | 0 |
| 2020 | 46 | 0 |
| 2021 | 41 | 0 |
| 2022 | 56 | 0 |
| 2023 | 67 | 0 |
| 2024 | 75 | 0 |
| 2025 | 64 | 0 |
| 2026 | 50 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K123027 | Capstone (R) Spinal SystemSummary page 4…MAX C. Predicate Devices The subject NuVasive CoRoent System is substantially equivalent to the primary predicate device, Medtronic CAPSTONE Spinal System (K123027), and additional predicate devices, NuVasive CoRoent System (K071795), NuVasive CoRoent Titanium System (K120918), NuVa… | 2013 |
| * | K071795 | Nuvasive Coroent SystemSummary page 4…ubstantially equivalent to the primary predicate device, Medtronic CAPSTONE Spinal System (K123027), and additional predicate devices, NuVasive CoRoent System (K071795), NuVasive CoRoent Titanium System (K120918), NuVasive CoRoent Sterile Implants System (K132601), and NuVasive CoRoent Thora… | 2007 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 4…cate device, Medtronic CAPSTONE Spinal System (K123027), and additional predicate devices, NuVasive CoRoent System (K071795), NuVasive CoRoent Titanium System (K120918), NuVasive CoRoent Sterile Implants System (K132601), and NuVasive CoRoent Thoracolumbar Implants (K140659). D. Devi… | 2012 |
| * | K132601 | Coroent Sterile Implants SystemSummary page 4…27), and additional predicate devices, NuVasive CoRoent System (K071795), NuVasive CoRoent Titanium System (K120918), NuVasive CoRoent Sterile Implants System (K132601), and NuVasive CoRoent Thoracolumbar Implants (K140659). D. Device Description The CoRoent System implants are manuf… | 2013 |
| * | K140659 | Coroent Thoracolumbar ImplantsSummary page 4…System (K071795), NuVasive CoRoent Titanium System (K120918), NuVasive CoRoent Sterile Implants System (K132601), and NuVasive CoRoent Thoracolumbar Implants (K140659). D. Device Description The CoRoent System implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026… | 2014 |
What descends from it? (480)
See all 4802 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 11 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 78 ancestors have a recall of any class.
- Of its descendants, K151472 (Nu Vasive, Incorporated, 2015) has gone furthest, with 479 descendants of its own.
- 12 other devices also cite its predicate K123027.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The NuVasive CoRoent System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent System (L and XL platforms) are intended for use at…
Read the full statement (147 words)
The NuVasive CoRoent System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent System (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the CoRoent System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141896: Coroent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141896
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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