510(k) · Cleared

Cleared

E-Z Link Cross Connector

K001372510(k) TraditionalCleared Jul 27, 200087-day reviewClass II21 CFR 888.3050

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

Depuyacromed · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jul 27, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 190 later devices descend from it.

Decided: Jul 27, 2000
Review: 87 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 0

190 later devices descend from it, 5 citing it directly.

This deviceK001372 E-Z Link Cross ConnectorDepuyacromed · 2000
Descendant · cites it directly · 184 of its ownK013296 Moss Miami Spinal SystemsDepuyacromed · 2001
Descendant · 2 generations on · 178 of its ownK092825 Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010
Descendant · 3 generations on · 177 of its ownK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
Descendant · 3 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
Descendant · 3 generations on · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011

Showing 5 of 190 descendants. See all descendants

Descendants cleared per year

2001high 22 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 190 · See all

K013296Moss Miami Spinal SystemsDepuyacromed · 2001 · cites it directly184descendants
K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010 · 2 generations on178descendants
K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010 · 3 generations on177descendants
K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 3 generations on111descendants
K110906Apex Spine SystemSpinecraft, LLC · 2011 · 3 generations on103descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001372	E-Z Link Cross Connector	Depuyacromed	2000	—
+1	K013296	Moss Miami Spinal Systems	Depuyacromed	2001	—
+2	K092825	Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer	Spinecraft, Inc.	2010	—
+3	K102488	Apex Spine System W/ Cocr Rods	Spinecraft, LLC	2010	—
+3	K120270	Venus Spinal Fixation System	L&K BIOMED Co., Ltd.	2012	—
+3	K110906	Apex Spine System	Spinecraft, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	4	0
2002	2	0
2003	1	0
2004	3	0
2010	2	0
2011	1	0
2012	4	0
2013	6	0
2014	6	0
2015	10	0
2016	4	0
2017	10	0
2018	13	0
2019	10	0
2020	16	0
2021	9	0
2022	13	0
2023	20	0
2024	22	0
2025	19	0
2026	15	0

FIG. 1 — Lineage of K001372, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (190)

See all 190

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

Number	Device	Applicant	Decided	Descendants
K013296	Moss Miami Spinal Systems	Depuyacromed	2001	184
K012971	Isola Spinal Systems	Depuyacromed	2001	2
K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…	Medos International SARL	2019	0
K013294	Monarch Spinal Systems	Depuyacromed	2001	0
K013295	Timx Spinal Systems	Depuyacromed	2001	0

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?

Of its descendants, K013296 (Depuyacromed, 2001) has gone furthest, with 184 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

https://510kreport.com/device/K001372 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001372: E-Z Link Cross Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001372

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026