510(k) · Cleared

Cleared

Gateway Thoracolumbar Plate System

K062407510(k) SpecialCleared Sep 6, 200620-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

Globus Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 6, 2006 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 1 other predicate after a 20-day review. Its family tree reaches back 5 generations to 1999. 127 later devices descend from it.

Decided: Sep 6, 2006
Review: 20 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K990745 (1999). 13 ancestors in all, the oldest K962628 (1997). 127 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
4 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
3 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
2 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
1 generation backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
This deviceK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
Descendant · cites it directly · 73 of its ownK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
Descendant · 2 generations on · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
Descendant · 3 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
Descendant · cites it directly · 50 of its ownK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
Descendant · 2 generations on · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014

Showing 5 of 127 descendants. See all descendants

Descendants cleared per year

2006high 23 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 127 · See all

K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010 · cites it directly73descendants
K131533Cayman MI Plate SystemK2m, Inc. · 2013 · 2 generations on72descendants
K172941CASCADIA Interbody SystemK2m · 2018 · 3 generations on52descendants
K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006 · cites it directly50descendants
K142699LITe Plate SystemStryker Corporation · 2014 · 2 generations on46descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K990745	Modification to Synthes Universal Spinal System	Synthes Spine	1999	—
−4	K992739	Click'x	Synthes Spine	2000	1
−3	K040442	Protex Stabilization System	Globus Medical, Inc.	2004	—
−2	K052069	Protex Stabilization System with Additional Componentes	Globus Medical, Inc.	2005	—
−1	K061202	Revere Stabilization System	Globus Medical, Inc.	2006	—
0 (this device)	K062407	Gateway Thoracolumbar Plate System	Globus Medical, Inc.	2006	—
+1	K100061	Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX	K2m, Inc.	2010	—
+2	K131533	Cayman MI Plate System	K2m, Inc.	2013	—
+3	K172941	CASCADIA Interbody System	K2m	2018	—
+1	K062836	Citadel Anterior Lumbar Plate System	Globus Medical, Inc.	2006	—
+2	K142699	LITe Plate System	Stryker Corporation	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
2001	2	0
2003	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0
2010	1	0
2012	1	0
2013	1	0
2014	2	0
2015	1	0
2016	1	0
2017	2	0
2018	6	0
2019	8	0
2020	8	0
2021	8	0
2022	15	0
2023	23	0
2024	16	0
2025	15	0
2026	17	0

FIG. 1 — Lineage of K062407, 1999–2026Source: 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.

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
*	K061202	Revere Stabilization System Summary page 1 …888.3060 Spinal Intervertebral Body Fixation Orthosis Product Codes KWQ. Regulatory Class 11.Panel code 87. PREDICATE DEVICES: Globus REVERE T M Stabilization System K061202 (SE date July 20, 2006) DePuy Profile Anterior Thoracolumbar Plate K973060 (SE date Nov 3, 1997). Product codes KWQ. Regulatory…	Globus Medical, Inc.	2006	—
*	K973060	Depuy Motech Profile Anterior Thoracolumbar Plate System Summary page 1 …gulatory Class 11.Panel code 87. PREDICATE DEVICES: Globus REVERE T M Stabilization System K061202 (SE date July 20, 2006) DePuy Profile Anterior Thoracolumbar Plate K973060 (SE date Nov 3, 1997). Product codes KWQ. Regulatory Class 11. DEVICE DESCRIPTION: The GATEWAYTm Thoracolumbar Plate System c…	Depuy, Inc.	1997	—

Also cleared against K061202: 29 other devices →

What descends from it? (127)

See all 127

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

Number	Device	Applicant	Decided	Descendants
K100061	Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX	K2m, Inc.	2010	73
K062836	Citadel Anterior Lumbar Plate System	Globus Medical, Inc.	2006	50
K092108	Truss Thoracolumbar Plate System	Globus Medical, Inc.	2009	42

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 7 years and passes through 2 companies; a new generation was cleared every 11 months on median.
1 of the 13 ancestors has a recall of any class.
Of its descendants, K100061 (K2m, Inc., 2010) has gone furthest, with 73 descendants of its own.
29 other devices also cite its predicate K061202.

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 GATEWAY TM Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062407 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062407: Gateway Thoracolumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062407

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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