510(k) · Cleared

Cleared

Spinal Usa Anterior Cervical Interbody Fusion Device

K083118510(k) TraditionalCleared May 27, 2009217-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

Spinal USA · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on May 27, 2009 as substantially equivalent to K081730 (Alphatec Spine, Inc., 2008) and 1 other predicate after a 217-day review. Its family tree reaches back 1 generation to 2008. 458 later devices descend from it.

Decided: May 27, 2009
Review: 217 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K073351 (2008). 2 ancestors in all. 458 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK073351 CrystalSpinal Elements, Inc. · 2008
This deviceK083118 Spinal Usa Anterior Cervical Interbody Fusion DeviceSpinal USA · 2009
Descendant · cites it directly · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
Descendant · 2 generations on · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
Descendant · 2 generations on · 444 of its ownK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
Descendant · 2 generations on · 441 of its ownK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016

Showing 5 of 458 descendants. See all descendants

Descendants cleared per year

2014high 66 (2023) · low 2 (2015)2026

Most influential descendants

Showing 5 of 458 · See all

K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · cites it directly453descendants
K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · 2 generations on449descendants
K140921Coroent Small Interbody SystemNu Vasive, Incorporated · 2014 · 2 generations on444descendants
K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015 · 2 generations on441descendants
K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K073351	Crystal	Spinal Elements, Inc.	2008	—
0 (this device)	K083118	Spinal Usa Anterior Cervical Interbody Fusion Device	Spinal USA	2009	—
+1	K140003	Coroent Small Interbody System	Nuvasive, Inc.	2014	—
+2	K142050	Nuvasive Coroent Small Contoured Interbody System	Nu Vasive, Incorporated	2014	—
+2	K140921	Coroent Small Interbody System	Nu Vasive, Incorporated	2014	—
+2	K150362	NuVasive CoRoent Small Interbody System	Nu Vasive, Incorporated	2015	—
+3	K160125	Cascadia Interbody System	K2m	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	4	0
2015	2	0
2016	5	0
2017	19	0
2018	19	0
2019	32	0
2020	47	0
2021	39	0
2022	53	0
2023	66	0
2024	56	0
2025	61	0
2026	55	0

FIG. 1 — Lineage of K083118, 2008–2026Source: 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? (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	Applicant	Decided	Recalls
*	K081730	Novel Cervical Spinal Spacer System Summary page 1 …roducts are Supplied clean and "NON-STERILE". PREDICATE DEVICE(S): The predicate devices previously cleared by FDA are the Novel Cervical Spinal Spacer, Alphatec Spine (K081730), Crystal, Spinal Elements (K073351) PERFORMANCE TESTING: The pre-clinical testing performed indicated that the Spinal USA Inter…	Alphatec Spine, Inc.	2008	—
*	K073351	Crystal Summary page 1 …STERILE". PREDICATE DEVICE(S): The predicate devices previously cleared by FDA are the Novel Cervical Spinal Spacer, Alphatec Spine (K081730), Crystal, Spinal Elements (K073351) PERFORMANCE TESTING: The pre-clinical testing performed indicated that the Spinal USA Interbody Fusion Device ACIF Systemn is s…	Spinal Elements, Inc.	2008	—

Also cleared against K081730: 15 other devices →

What descends from it? (458)

See all 458

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

Number	Device	Applicant	Decided	Descendants
K140003	Coroent Small Interbody System	Nuvasive, Inc.	2014	453
K161809	ShurFit CpTi-HA ACIF Interbody Fusion System	Precision Spine, Inc.	2016	5

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?

None of the 2 ancestors has a recall.
Of its descendants, K140003 (Nuvasive, Inc., 2014) has gone furthest, with 453 descendants of its own.
15 other devices also cite its predicate K081730.

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?

The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083118 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083118: Spinal Usa Anterior Cervical Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083118

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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