510(k) · Cleared

Cleared

Opticage Interbody Fusion Device, Model 9080-00

K132479510(k) SpecialCleared Sep 19, 201342-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

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

Cleared on Sep 19, 2013 after a 42-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Sep 19, 2013
Review: 42 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK132479 Opticage Interbody Fusion Device, Model 9080-00Interventional Spine, Inc. · 2013
Descendant · cites it directly · 0 of its ownK133583 Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K132479	Opticage Interbody Fusion Device, Model 9080-00	Interventional Spine, Inc.	2013	—
+1	K133583	Opticage Interbody Fusion Device, Model Series 9070	Interventional Spine, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K132479, 2013–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133583	Opticage Interbody Fusion Device, Model Series 9070	Interventional Spine, Inc.	2014	0

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?

Of its descendants, K133583 (Interventional Spine, Inc., 2014) has gone furthest, with 0 descendants of its own.

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. 2013, 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	—

https://510kreport.com/device/K132479 · printed Nov 5, 2026

Cite this page

510(k) Report. “K132479: Opticage Interbody Fusion Device, Model 9080-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132479

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026