510(k) · Cleared

Cleared

Venture Anterior Cervical Plate System

K061274510(k) SpecialCleared May 25, 200617-day reviewClass II21 CFR 888.3060

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

Medtronic Sofamor Danek · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 25, 2006 as substantially equivalent to K042922 (Medtronic Sofamor Danek, Inc., 2004) after a 17-day review. Its family tree reaches back 3 generations to 1998. 1 of the 676 devices in its family, counting itself, has a Class I recall. 669 later devices descend from it.

Decided: May 25, 2006
Review: 17 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K973854 (1998). 6 ancestors in all, the oldest K792352 (1979). 669 later devices descend from it, 5 citing it directly. 1 of the 676 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
2 generations backK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
1 generation backK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
This deviceK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
Descendant · cites it directly · 637 of its ownK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
Descendant · 2 generations on · 397 of its ownK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
Descendant · 2 generations on · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
Descendant · 3 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
Descendant · 2 generations on · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014

Showing 5 of 669 descendants. See all descendants

Descendants cleared per year

2008high 77 (2023) · low 0 (2009)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 669 · See all

K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008 · cites it directly637descendants
K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010 · 2 generations on397descendants
K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · 2 generations on389descendants
K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 3 generations on331descendants
K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · 2 generations on330descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K973854	Orion Anterior Cervical Plate System	Sofamor Danek USA,Inc.	1998	—
−2	K042235	Orion Anterior Cervical Plating System	Medtronic Sofamor Danek	2004	—
−1	K042922	Venture Anterior Cervical Plating System	Medtronic Sofamor Danek, Inc.	2004	—
0 (this device)	K061274	Venture Anterior Cervical Plate System	Medtronic Sofamor Danek	2006	—
+1	K073285	Peek Prevail Cervical Interbody Device	Medtronic Sofamor Danek USA, Inc.	2008	—
+2	K094042	Peek Prevail Cervical Interbody Device	Medtronic Sofamor Danek	2010	—
+2	K100214	Cornerstone PSR Cervical Interbody Fusion Device	Medtronic Sofamor Danek	2010	—
+3	K111264	Cornerstone (R) PSR Cervical Fusion System	Medtronic Sofamor Danek USA	2011	—
+2	K133494	Chesapeake Spinal System	K2m, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1980	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	4	0
2011	10	0
2012	4	0
2013	8	0
2014	13	0
2015	14	0
2016	24	0
2017	41	0
2018	32	0
2019	46	0
2020	61	0
2021	64	1
2022	64	0
2023	77	0
2024	73	0
2025	68	0
2026	65	0

FIG. 1 — Lineage of K061274, 1998–2026Source: 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 KWQ device

#1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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
*	K042922	Venture Anterior Cervical Plating System Summary page 2 …ervical Plate System components were demonstrated to be substantially equivalent to the predicate VENTURETM Anterior Cervical Plate screw and plate components cleared in K042922. ju L,..S , DEPARTME…	Medtronic Sofamor Danek, Inc.	2004	—

Also cleared against K042922: 3 other devices →

What descends from it? (669)

See all 669

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

Number	Device	Applicant	Decided	Descendants
K073285	Peek Prevail Cervical Interbody Device	Medtronic Sofamor Danek USA, Inc.	2008	637
K102820	Appliance, Fixation, Spinal Intervertebral Body	Alphatec Spine, Inc.	2010	38
K182885	Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…	Medtronic Sofamor Danek USA, Inc.	2019	8
K121862	Rex Anterior Cervical Plate System	Dio Medical Co., Ltd.	2012	7
K140234	Aspiron Acp System	U&I Corp.	2014	6

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K073285 (Medtronic Sofamor Danek USA, Inc., 2008) has gone furthest, with 637 descendants of its own.
3 other devices also cite its predicate K042922.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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	27	101	2	288
2008	32	70	33	348
2009	23	90	35	355
2010	23	104	2	691
2011	22	95	5	415
2012	26	90	7	544
2013	22	88	6	796
2014	17	124	0	546
2015	25	102	2	562
2016	15	121	9	502
2017	20	67	8	492
2018	22	95	1	341
2019	26	81	0	298
2020	26	55	0	400
2021	17	59	0	591
2022	18	85	0	392
2023	16	59	0	320
2024	17	64	0	419
2025	7	64	0	248
2026	10	76	0	—

What is it indicated for?

The VENTURETM Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061274: Venture Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061274

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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