510(k) · Cleared

Cleared

Cimplicity Spinal System

K073320510(k) TraditionalCleared Feb 7, 200873-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

Spine Smith Partners L.P. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Feb 7, 2008 as substantially equivalent to P000028 (Medtronic Sofamor Danek USA, Inc., 2002) after a 73-day review. Its family tree reaches back 1 generation to 2002. 1 of the 1,020 devices in its family, counting itself, has a Class I recall. 1,018 later devices descend from it.

Decided: Feb 7, 2008
Review: 73 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P000028 (2002). 1,018 later devices descend from it, 2 citing it directly. 1 of the 1,020 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backP000028 Affinity (TM) Cage SystemMedtronic Sofamor Danek USA, Inc. · 2002
This deviceK073320 Cimplicity Spinal SystemSpine Smith Partners L.P. · 2008
Descendant · cites it directly · 1,008 of its ownK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
Descendant · 2 generations on · 609 of its ownK101923 Concorde Curve SystemDepuy Spine · 2010
Descendant · 2 generations on · 602 of its ownK110454 Cougar LS Lateral Cage SystemJohnson & Johnson · 2011
Descendant · 2 generations on · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
Descendant · 2 generations on · 591 of its ownK113348 Cougar SystemJohnson & Johnson · 2011

Showing 5 of 1,018 descendants. See all descendants

Descendants cleared per year

2008high 100 (2023) · low 1 (2008)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 1,018 · See all

K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009 · cites it directly1,008descendants
K101923Concorde Curve SystemDepuy Spine · 2010 · 2 generations on609descendants
K110454Cougar LS Lateral Cage SystemJohnson & Johnson · 2011 · 2 generations on602descendants
K101302Aleutian Ibf SystemK2m, Inc. · 2010 · 2 generations on595descendants
K113348Cougar SystemJohnson & Johnson · 2011 · 2 generations on591descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P000028	Affinity (TM) Cage System	Medtronic Sofamor Danek USA, Inc.	2002	—
0 (this device)	K073320	Cimplicity Spinal System	Spine Smith Partners L.P.	2008	—
+1	K081917	Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems	Depuy Spine, Inc.	2009	—
+2	K101923	Concorde Curve System	Depuy Spine	2010	—
+2	K110454	Cougar LS Lateral Cage System	Johnson & Johnson	2011	—
+2	K101302	Aleutian Ibf System	K2m, Inc.	2010	—
+2	K113348	Cougar System	Johnson & Johnson	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	4	0
2011	15	0
2012	13	0
2013	13	0
2014	27	0
2015	44	0
2016	47	0
2017	90	0
2018	76	0
2019	80	0
2020	92	0
2021	82	1
2022	77	0
2023	100	0
2024	100	0
2025	81	0
2026	75	0

FIG. 1 — Lineage of K073320, 2002–2026Source: 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.

1 device in this family has a Class I recall. 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? (1)

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
*	P000028	Affinity (TM) Cage System Summary page 1 …sion Device Regulatory Class: 888.3080 Classification Code: Class 11 Product Code: ODP Predicate De-vices: Affinity Cervical Cage (P000028) and others. Device Description: The Cixnplicity system is a rectangular interbody fusion device. The…	Medtronic Sofamor Danek USA, Inc.	2002	—

Also cleared against P000028: 15 other devices →

What descends from it? (1,018)

See all 1,018

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

Number	Device	Applicant	Decided	Descendants
K081917	Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems	Depuy Spine, Inc.	2009	1,008
K080971	Spinesmith Cimplicity Spinal System	Spine Smith Partners L.P.	2008	406

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K081917 (Depuy Spine, Inc., 2009) has gone furthest, with 1,008 descendants of its own.
15 other devices also cite its predicate P000028.

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. 2008, 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 Cimplicity Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six 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/K073320 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073320: Cimplicity Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073320

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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