510(k) · Cleared
ClearedCoroent Sterile Implants 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 Dec 24, 2013 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) and 1 other predicate after a 126-day review. Its family tree reaches back 3 generations to 1996. 1 of the 605 devices in its family, counting itself, has a Class I recall. 596 later devices descend from it.
- Decided
- Dec 24, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P950002 (1996). 8 ancestors in all. 596 later devices descend from it, 5 citing it directly. 1 of the 605 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 2 generations backK092901 Epicage Interbody Fusion DeviceR Tree Innovations · 2010
- 1 generation backK130548 Epicage Interbody Fusion DeviceAlphatec Spine, Inc. · 2013
- This deviceK132601 Coroent Sterile Implants SystemNu Vasive, Incorporated · 2013
- Descendant · cites it directly · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · cites it directly · 483 of its ownK140659 Coroent Thoracolumbar ImplantsNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 480 of its ownK141896 Coroent SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 596 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 596 · See all- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · cites it directly590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
- K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated · 2014 · cites it directly483descendants
- K141896Coroent SystemNu Vasive, Incorporated · 2014 · cites it directly480descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −2 | K092901 | Epicage Interbody Fusion Device | R Tree Innovations | 2010 | — |
| −1 | K130548 | Epicage Interbody Fusion Device | Alphatec Spine, Inc. | 2013 | — |
| 0 (this device) | K132601 | Coroent Sterile Implants System | Nu Vasive, Incorporated | 2013 | — |
| +1 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +1 | K140659 | Coroent Thoracolumbar Implants | Nu Vasive, Incorporated | 2014 | — |
| +1 | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 18 | 0 |
| 2017 | 27 | 0 |
| 2018 | 31 | 0 |
| 2019 | 43 | 0 |
| 2020 | 64 | 0 |
| 2021 | 51 | 1 |
| 2022 | 61 | 0 |
| 2023 | 76 | 0 |
| 2024 | 83 | 0 |
| 2025 | 72 | 0 |
| 2026 | 58 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K071795 | Nuvasive Coroent SystemSummary page 1…P C. Predicate Devices The subject Nu Vasive CoRoent Sterile Implants System is substantially equivalent to the predicate devices, Mi Vasive CoRoent System (K07 1795) and Aiphatec Spine Epicage Interbody Fusion Device (K130548). D. Device Description The CoRoent Sterile Implants… | 2007 |
| * | K130548 | Epicage Interbody Fusion DeviceSummary page 1…e Implants System is substantially equivalent to the predicate devices, Mi Vasive CoRoent System (K07 1795) and Aiphatec Spine Epicage Interbody Fusion Device (K130548). D. Device Description The CoRoent Sterile Implants are manufactured from PEEK-Optima® LT- I conforming to ASTM… | 2013 |
What descends from it? (596)
See all 5965 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K140319 (Nuvasive, Inc., 2014) has gone furthest, with 590 descendants of its own.
- 41 other devices also cite its predicate K071795.
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. 2013, 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 Sterile Implants System is a device system indicated for the following: Intervertebral Body Fusion The NuVasive CoRoent Sterile Implants System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The NuVasive CoRoent Sterile Implants System is intended for use at either one level or two contiguous levels in the lumbar…
Read the full statement (254 words)
The NuVasive CoRoent Sterile Implants System is a device system indicated for the following:
Intervertebral Body Fusion
The NuVasive CoRoent Sterile Implants System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.
The NuVasive CoRoent Sterile Implants System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment.
The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Partial Vertebral Body Replacement
The NuVasive CoRoent Sterile Implants System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132601: Coroent Sterile Implants System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132601
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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