510(k) · Cleared

Cleared

Modification to Vertebron SCP Cervical Plate System

K043181510(k) SpecialCleared Dec 17, 200430-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

Vertebron, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 17, 2004 as substantially equivalent to K040003 (Vertebron, Inc., 2004) after a 30-day review. Its family tree reaches back 6 generations to 1992. 11 later devices descend from it.

Decided: Dec 17, 2004
Review: 30 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K922087 (1992). 22 ancestors in all. 11 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 6 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
5 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
4 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
3 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
2 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
1 generation backK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
This deviceK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
Descendant · cites it directly · 10 of its ownK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
Descendant · 2 generations on · 9 of its ownK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
Descendant · cites it directly · 6 of its ownK081567 Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
Descendant · cites it directly · 3 of its ownK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
Descendant · 2 generations on · 2 of its ownK180022 Athena Cervical Plate SystemMedyssey USA, Inc. · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all

K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005 · cites it directly10descendants
K062110Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006 · 2 generations on9descendants
K081567Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008 · cites it directly6descendants
K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008 · cites it directly3descendants
K180022Athena Cervical Plate SystemMedyssey USA, Inc. · 2018 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K922087	Anterior Cervical Plate System	Sofamor Danek Mfg., Inc.	1992	—
−5	K990005	Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System	Spinal Concepts, Inc.	1999	1
−4	K000486	Abc Cervical Plating System	Aesculap, Inc.	2000	—
−3	K012184	Blackstone Iii Anterior Cervical Plating System	Blackstone Medical, Inc.	2002	—
−2	K030595	Blackstone Fusion Anterior Cervical Plating System	Blackstone Medical, Inc.	2003	—
−1	K040003	Vertebron SCP Cervical Plate System	Vertebron, Inc.	2004	—
0 (this device)	K043181	Modification to Vertebron SCP Cervical Plate System	Vertebron, Inc.	2004	—
+1	K051815	Modification to Vertebron SCP Cervical Plate System	Vertebron, Inc.	2005	—
+2	K062110	Vertebron SCP Cervical Plate System	Vertebron, Inc.	2006	—
+1	K081567	Vertebron SSP Cervical Plating System	Vertebron, Inc.	2008	—
+1	K073530	Accin Anterior Cervical Plate System	Accelerated Innovation, LLC	2008	—
+2	K180022	Athena Cervical Plate System	Medyssey USA, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0
1995	1	0
1997	2	0
1998	4	0
1999	3	0
2000	1	0
2001	2	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	2	0
2009	1	0
2013	1	0
2017	1	0
2018	1	0
2019	2	0
2023	1	0

FIG. 1 — Lineage of K043181, 1992–2023Source: 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 KWQ? 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
*	K040003	Vertebron SCP Cervical Plate System Summary page 1 …rvical Plating System PROPRIETARY NAME: VERTEBRON SCP TM Cervical Plate System PREDICATE DEVICES: VERTEBRON SCP TM Cervical Plate System - K040003 INTENDED USE: The VERTEBRON SCPTM Cervical Plate System is intended for non pedicle fixation…	Vertebron, Inc.	2004	—

Also cleared against K040003: 5 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K051815	Modification to Vertebron SCP Cervical Plate System	Vertebron, Inc.	2005	10
K081567	Vertebron SSP Cervical Plating System	Vertebron, Inc.	2008	6
K073530	Accin Anterior Cervical Plate System	Accelerated Innovation, LLC	2008	3
K091396	Cardo Medical Anterior Cervical Plate System	Cardo Medical Corp.	2009	2

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?

The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
3 of the 22 ancestors have a recall of any class.
Of its descendants, K051815 (Vertebron, Inc., 2005) has gone furthest, with 10 descendants of its own.
5 other devices also cite its predicate K040003.

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 VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043181: Modification to Vertebron SCP 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/K043181

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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