510(k) · Cleared

Cleared

Atrax Anterior Cervical Plating System

K150834510(k) TraditionalCleared Jul 10, 2015102-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

X-Spine Systems, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 10, 2015 as substantially equivalent to K052292 (X-Spine Systems, Inc., 2005) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 2000.

Decided: Jul 10, 2015
Review: 102 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K994239 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK994239 Zephir Anterior Cervical Plate SystemMedtronic Sofamor Danek, Inc. · 2000
This deviceK150834 Atrax Anterior Cervical Plating SystemX-Spine Systems, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K994239	Zephir Anterior Cervical Plate System	Medtronic Sofamor Danek, Inc.	2000	—
0 (this device)	K150834	Atrax Anterior Cervical Plating System	X-Spine Systems, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K150834, 2000–2015Source: 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

Get a 510(k) Report

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
*	K052292	Spider Cervical Plating (SCP) System Summary page 4 …Product Code: KWQ III. PREDICATE DEVICES • Primary Predicate: X‐spine Systems, Inc. – Spider Cervical Plating System (K052292) o This predicate has not been subject to a design related recall. • Additional Predicate: Me…	X-Spine Systems, Inc.	2005	—
*	K994239	Zephir Anterior Cervical Plate System Summary page 4 …ot been subject to a design related recall. • Additional Predicate: Medronic Sofamor Danek, Inc. – ZEPHIR Anterior Cervical Plate System (K994239 ) IV. DEVICE DESCRIPTION The Atrax Anterior Cervical Plating System consists of screws and plates offered in various sizes…	Medtronic Sofamor Danek, Inc.	2000	—

Also cleared against K052292: 14 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?

None of the 2 ancestors has a recall.
14 other devices also cite its predicate K052292.

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. 2015, 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 Atrax Anterior Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: Degenerative Disc Disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal tumors, Deformity (e.g., kyphosis, lordosis, scoliosis), Pseudarthrosis, and/or Failed previous fusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K150834 · printed Nov 5, 2026

Cite this page

510(k) Report. “K150834: Atrax Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150834

Report an extraction error

Are you the manufacturer?

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