510(k) · Cleared

Cleared

Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage

K083425510(k) TraditionalCleared Mar 20, 2009121-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

Adaptive Specialty, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Mar 20, 2009 after a 121-day review. The FDA summary names no predicate by number. 17 later devices descend from it.

Decided: Mar 20, 2009
Review: 121 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 0

17 later devices descend from it, 2 citing it directly.

This deviceK083425 Fusion Advantage Cervical Cage, Fusion Advantage Lumbar CageAdaptive Specialty, LLC · 2009
Descendant · cites it directly · 15 of its ownK170297 Tranquil Interbody SystemNexus Spine, LLC · 2017
Descendant · 2 generations on · 8 of its ownK181702 Tranquil-L Interbody SystemNexus Spine, LLC · 2018
Descendant · 3 generations on · 7 of its ownK212498 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022
Descendant · 2 generations on · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
Descendant · 3 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2017high 4 (2023) · low 0 (2019)2026

Most influential descendants

Showing 5 of 17 · See all

K170297Tranquil Interbody SystemNexus Spine, LLC · 2017 · cites it directly15descendants
K181702Tranquil-L Interbody SystemNexus Spine, LLC · 2018 · 2 generations on8descendants
K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022 · 3 generations on7descendants
K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · 2 generations on7descendants
K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K083425	Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage	Adaptive Specialty, LLC	2009	—
+1	K170297	Tranquil Interbody System	Nexus Spine, LLC	2017	—
+2	K181702	Tranquil-L Interbody System	Nexus Spine, LLC	2018	—
+3	K212498	Stable-L Standalone Lumbar Interbody System	Nexus Spine, LLC	2022	—
+2	K181621	Stable-C Interbody System	Nexus Spine, LLC	2018	—
+3	K231763	Stable-C Interbody System	Nexus Spine, LLC	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	2	0
2018	3	0
2020	1	0
2022	2	0
2023	4	0
2024	3	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K083425, 2009–2026Source: 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.

Planning a device in ODP? 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 ODP device

#1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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?

The FDA summary names no predicate by number.

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K170297	Tranquil Interbody System	Nexus Spine, LLC	2017	15
K170844	Gemini-C Hybrid Cervical Interbody System	Osseus Fusion Systems, LLC	2017	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, K170297 (Nexus Spine, LLC, 2017) has gone furthest, with 15 descendants of its own.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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	0	—	0	0
2008	8	89	0	2
2009	12	127	1	21
2010	9	151	0	54
2011	25	113	1	38
2012	17	93	0	92
2013	18	187	1	78
2014	26	118	0	43
2015	24	180	0	51
2016	17	112	0	37
2017	33	104	0	39
2018	25	133	0	51
2019	22	92	0	141
2020	14	89	1	86
2021	18	121	0	161
2022	12	92	0	50
2023	34	165	0	36
2024	10	76	0	55
2025	11	87	2	57
2026	19	117	0	—

What is it indicated for?

Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior…

Read the full statement (246 words)

Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with

degenerative disc disease (DDD) of the cervical spine with accompanying radicular

symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the

disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical

Cages are used to facilitate intervertebral body fusion in the cervical spine and are

placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Fusion

Advantage Cervical Cages are to be used with supplemental fixation. Patients should

have at least six (6) weeks of non-operative treatment prior to treatment with an

intervertebral cage.

The Fusion Advantage Lumbar Cage is indicated for intervertebral body fusion

procedures in skeletally mature patients with degenerative disc disease (DDD) of the

lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is

defined as discogenic back pain with degeneration of the disc confirmed by history and

radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or

retrolisthesis at the involved level(s). Fusion Advantage Lumbar Cage implants are to be

used with autogenous bone graft and implanted via an open posterior, transforaminal or

an lateral approach. The Fusion Advantage Lumbar Cages are to be used with

supplemental fixation. Patients should have at least (6) months of non-operative

treatment prior to treatment with an intervertebral cage. Patients with previous non-

fusion spinal surgery at involved level may be treated with the device.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083425 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083425: Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083425

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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