510(k) · Cleared

Recalled · Class II · 2013

Daytona Anterior Cervical Cage

K110733510(k) TraditionalCleared Aug 25, 2011162-day reviewClass II21 CFR 888.3080Recalls 1

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

Spinenet, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Aug 25, 2011 as substantially equivalent to K073351 (Spinal Elements, Inc., 2008) and 2 other predicates after a 162-day review. Its family tree reaches back 1 generation to 2001. 481 later devices descend from it. It has been recalled once.

Decided: Aug 25, 2011
Review: 162 days
Class: Class II
Product code: ODP
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to P980048 (2001). 3 ancestors in all. 481 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
This deviceK110733 Daytona Anterior Cervical CageSpinenet, LLC · 2011
Descendant · cites it directly · 454 of its ownK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
Descendant · 2 generations on · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
Descendant · 3 generations on · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
Descendant · 3 generations on · 444 of its ownK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
Descendant · 3 generations on · 441 of its ownK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015

Showing 5 of 481 descendants. See all descendants

Descendants cleared per year

2013high 69 (2023) · low 2 (2013)2026

Most influential descendants

Showing 5 of 481 · See all

K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013 · cites it directly454descendants
K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · 2 generations on453descendants
K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · 3 generations on449descendants
K140921Coroent Small Interbody SystemNu Vasive, Incorporated · 2014 · 3 generations on444descendants
K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015 · 3 generations on441descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P980048	Bak/Cervical (Bak/C) Interbody Fusion System	Sulzer Spine-Tech	2001	—
0 (this device)	K110733	Daytona Anterior Cervical Cage	Spinenet, LLC	2011	—
+1	K123206	Maxim Surgical X-Treme Interbody Fusion System	Maxim Surgical	2013	—
+2	K140003	Coroent Small Interbody System	Nuvasive, Inc.	2014	—
+3	K142050	Nuvasive Coroent Small Contoured Interbody System	Nu Vasive, Incorporated	2014	—
+3	K140921	Coroent Small Interbody System	Nu Vasive, Incorporated	2014	—
+3	K150362	NuVasive CoRoent Small Interbody System	Nu Vasive, Incorporated	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0
2014	8	0
2015	4	0
2016	6	0
2017	24	0
2018	22	0
2019	32	0
2020	48	0
2021	41	0
2022	53	0
2023	69	0
2024	56	0
2025	61	0
2026	55	0

FIG. 1 — Lineage of K110733, 2001–2026Source: 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? (3)

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
*	K073351	Crystal Summary page 1 …P Class 11 3. Predicate or legally marketed devices which are substantially equivalent: Spinal Elements Crystal Cervical Cage (K073351) Zimmer BAK/C Vista Interbody Fusion (P980048 S3) Integra Cervical Cage - Calvary Spine LLC (K082260) 4. Descrip…	Spinal Elements, Inc.	2008	—
*	P980048	Bak/Cervical (Bak/C) Interbody Fusion System Summary page 1 …dicate or legally marketed devices which are substantially equivalent: Spinal Elements Crystal Cervical Cage (K073351) Zimmer BAK/C Vista Interbody Fusion (P980048 S3) Integra Cervical Cage - Calvary Spine LLC (K082260) 4. Description of the device: The Daytona Anterior Cerv…	Sulzer Spine-Tech	2001	—
*	K082260	Integra Cervical and Petra Plif Lumbar Cages Summary page 1 …ivalent: Spinal Elements Crystal Cervical Cage (K073351) Zimmer BAK/C Vista Interbody Fusion (P980048 S3) Integra Cervical Cage - Calvary Spine LLC (K082260) 4. Description of the device: The Daytona Anterior Cervical Cage system was developed as an intracorporeal implant fo…	Calvary Spine, LLC	2008	—

Also cleared against K073351: 26 other devices →

What descends from it? (481)

See all 481

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

Number	Device	Applicant	Decided	Descendants
K123206	Maxim Surgical X-Treme Interbody Fusion System	Maxim Surgical	2013	454
K142026	Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device	Spinefrontier, Inc.	2014	190
K133815	Intess Cervical Cage System	Kalitec Direct, LLC	2014	4
K141337	Arena-C	Spinefrontier, Inc.	2014	1
K132718	Integrity Spine Core System	Integrity Spine	2013	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 5, 2013	Class II	Z-2103-2013	Error in labeling	The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K123206 (Maxim Surgical, 2013) has gone furthest, with 454 descendants of its own.
26 other devices also cite its predicate K073351.

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. 2011, 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?

Read the full statement (130 words)

The Daytona Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level. ODD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Daytona Anterior Cervical Cage System is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to Ti disc levels using autograft bone. The Daytona Anterior Cervical Cage System is 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110733 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110733: Daytona Anterior Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110733

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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