510(k) · Cleared

Cleared

Fixed Variable & Corpectomy Cervical Plate System

K103838510(k) TraditionalCleared Feb 15, 201147-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

Precision Surgery, Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 15, 2011 as substantially equivalent to K032815 (Precision Surgery Limited, 2004) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 2004.

Decided: Feb 15, 2011
Review: 47 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K032815 (2004). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK032815 Precision Surgery Limited Variable and Fixed Cervical Plate SystemPrecision Surgery Limited · 2004
This deviceK103838 Fixed Variable & Corpectomy Cervical Plate SystemPrecision Surgery, Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032815	Precision Surgery Limited Variable and Fixed Cervical Plate System	Precision Surgery Limited	2004	—
0 (this device)	K103838	Fixed Variable & Corpectomy Cervical Plate System	Precision Surgery, Ltd.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K103838, 2004–2011Source: 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? (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
*	K032815	Precision Surgery Limited Variable and Fixed Cervical Plate System Summary page 1 …lloy (NiTi per ASTM F2063). Predicate Device: Fixed, Variable & Corpectomy Cervical Plate System (K03281 5/K073708) Page 14…	Precision Surgery Limited	2004	—
*	K073708	Fixed, Variable & Corpectomy Cervical Plate System Summary page 1 …i per ASTM F2063). Predicate Device: Fixed, Variable & Corpectomy Cervical Plate System (K03281 5/K073708) Page 14…	Precision Surgery, Ltd.	2008	3

Also cleared against K032815: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K032815.

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. 2011, this device’s year, is highlighted.

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 Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103838 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103838: Fixed Variable & Corpectomy 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/K103838

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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