510(k) · Cleared

Cleared

Nuvasive Coroent System

K071795510(k) AbbreviatedCleared Dec 4, 2007155-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nuvasive, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 4, 2007 as substantially equivalent to K071922 (Rsb Spine, LLC, 2007) after a 155-day review. Its family tree reaches back 1 generation to 2007. 1 of the 1,124 devices in its family, counting itself, has a Class I recall. 1,122 later devices descend from it.

Decided: Dec 4, 2007
Review: 155 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K071922 (2007). 1,122 later devices descend from it, 42 citing it directly. 1 of the 1,124 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
This deviceK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
Descendant · cites it directly · 933 of its ownK082128 Depuy Spine Lateral Cage SystemDepuy Spine · 2008
Descendant · 2 generations on · 932 of its ownK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
Descendant · cites it directly · 921 of its ownK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
Descendant · 2 generations on · 869 of its ownK102293 Caliber SpacerGlobus Medical, Inc. · 2011
Descendant · cites it directly · 762 of its ownK111512 Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011

Showing 5 of 1,122 descendants. See all descendants

Descendants cleared per year

2008high 99 (2024) · low 3 (2008)2026

Class I recalls in this family

K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 1,122 · See all

K082128Depuy Spine Lateral Cage SystemDepuy Spine · 2008 · cites it directly933descendants
K090899Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009 · 2 generations on932descendants
K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009 · cites it directly921descendants
K102293Caliber SpacerGlobus Medical, Inc. · 2011 · 2 generations on869descendants
K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011 · cites it directly762descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K071922	Interplate Interbody Fusion Device, Models C, CGC, L and LGC	Rsb Spine, LLC	2007	—
0 (this device)	K071795	Nuvasive Coroent System	Nuvasive, Inc.	2007	—
+1	K082128	Depuy Spine Lateral Cage System	Depuy Spine	2008	—
+2	K090899	Depuy Spine Lateral System	Depuy Spine, Inc.	2009	—
+1	K093242	Patriot Transcontinental Llif Spacer	Globus Medical, Inc.	2009	—
+2	K102293	Caliber Spacer	Globus Medical, Inc.	2011	—
+1	K111512	Bonebac T-Plif Intervertebral Body Fusion Device System	Thompson Mis, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	3	0
2009	4	0
2010	5	0
2011	12	0
2012	24	0
2013	37	0
2014	44	0
2015	44	0
2016	68	0
2017	95	0
2018	87	0
2019	88	0
2020	95	0
2021	81	1
2022	81	0
2023	98	0
2024	99	0
2025	81	0
2026	76	0

FIG. 1 — Lineage of K071795, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K071922	Interplate Interbody Fusion Device, Models C, CGC, L and LGC Cleared while this submission was under review Summary page 1 …0 Product Code: MAX, MQP C. PredicateDevices The subject device is substantially equivalent to RSB's InterFix device cleared under K071922. D. Device Description The NuVasive CoRoent System is an implantable device manufactured from PEEK and titaniu…	Rsb Spine, LLC	2007	—

Also cleared against K071922: 4 other devices →

What descends from it? (1,122)

See all 1,122

42 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082128	Depuy Spine Lateral Cage System	Depuy Spine	2008	933
K093242	Patriot Transcontinental Llif Spacer	Globus Medical, Inc.	2009	921
K111512	Bonebac T-Plif Intervertebral Body Fusion Device System	Thompson Mis, Inc.	2011	762
K120368	Capstone Control Spinal System	Medtronic Sofamor Danek USA, Inc.	2012	761
K123045	Brigade Standalone System	Nuvasive, Inc.	2013	696
K082235	Blackstone Pillar XL Peek Spacers	Blackstone Medical, Inc.	2008	693
K120918	Nuvasive Coroent Titanium System	Nuvasive, Inc.	2012	642
K101051	Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX	Stryker Spine	2010	641
K110454	Cougar LS Lateral Cage System	Johnson & Johnson	2011	602
K133455	Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic	Pioneer Surgical Technology, Inc.	2014	596

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?

Its one ancestor has no recall.
Of its descendants, K082128 (Depuy Spine, 2008) has gone furthest, with 933 descendants of its own.
4 other devices also cite its predicate K071922.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)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?

Intervertebral Body Fusion The NuVasive CoRoent 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 CoRoent L and XL platforms are 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 I spondylolisthesis. DDD is…

Read the full statement (236 words)

Intervertebral Body Fusion

The NuVasive CoRoent 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 CoRoent L and XL platforms are 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 I 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 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/K071795 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071795: Nuvasive Coroent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071795

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