510(k) · Cleared

Cleared

Cambria

K082309510(k) TraditionalCleared Apr 9, 2009239-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

Seaspine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Apr 9, 2009 after a 239-day review. The FDA summary names no predicate by number. 201 later devices descend from it.

Decided: Apr 9, 2009
Review: 239 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 0

201 later devices descend from it, 3 citing it directly.

This deviceK082309 CambriaSeaspine, Inc. · 2009
Descendant · cites it directly · 168 of its ownK092521 ZUMA-CSeaspine, Inc. · 2010
Descendant · 2 generations on · 131 of its ownK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
Descendant · cites it directly · 116 of its ownK142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)…Seaspine, Inc. · 2014
Descendant · 2 generations on · 103 of its ownK162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI…SeaSpine Orthopedics Corporation · 2016
Descendant · 3 generations on · 99 of its ownK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014

Showing 5 of 201 descendants. See all descendants

Descendants cleared per year

2010high 34 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 201 · See all

K092521ZUMA-CSeaspine, Inc. · 2010 · cites it directly168descendants
K102547Coroent Interlock SystemNuvasive, Inc. · 2011 · 2 generations on131descendants
K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc. · 2014 · cites it directly116descendants
K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation · 2016 · 2 generations on103descendants
K142299CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014 · 3 generations on99descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K082309	Cambria	Seaspine, Inc.	2009	—
+1	K092521	ZUMA-C	Seaspine, Inc.	2010	—
+2	K102547	Coroent Interlock System	Nuvasive, Inc.	2011	—
+1	K142488	SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene…	Seaspine, Inc.	2014	—
+2	K162715	SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene…	SeaSpine Orthopedics Corporation	2016	—
+3	K142299	CoRoent Small Interlock System	Nu Vasive, Incorporated	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	2	0
2013	1	0
2014	2	0
2015	2	0
2016	6	0
2017	10	0
2018	8	0
2019	8	0
2020	11	0
2021	15	0
2022	22	0
2023	28	0
2024	29	0
2025	34	0
2026	22	0

FIG. 1 — Lineage of K082309, 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

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (201)

See all 201

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

Number	Device	Applicant	Decided	Descendants
K092521	ZUMA-C	Seaspine, Inc.	2010	168
K142488	SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…	Seaspine, Inc.	2014	116
K171046	SeaSpine Cambria System	SeaSpine Orthopedics Corporation	2017	62

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, K092521 (Seaspine, Inc., 2010) has gone furthest, with 168 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?

Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in

skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin

with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.

Patients should have received at least six weeks of non-operative treatment prior to treatment with the

device. Devices are intended to be implanted via an open, anterior approach and used with autogenous

bone and supplemental fixation, such as an anterior plating system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082309 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082309: Cambria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082309

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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