510(k) · Cleared

Cleared

Expedium Spine System

K041119510(k) SpecialCleared Jul 19, 200481-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

Depuy Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jul 19, 2004 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) after an 81-day review. Its family tree reaches back 1 generation to 2004. 1 of the 642 devices in its family, counting itself, has a Class I recall. 640 later devices descend from it.

Decided: Jul 19, 2004
Review: 81 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K033901 (2004). 640 later devices descend from it, 29 citing it directly. 1 of the 642 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK033901 Merlin Spine SystemDepuy Spine, Inc. · 2004
This deviceK041119 Expedium Spine SystemDepuy Spine, Inc. · 2004
Descendant · cites it directly · 538 of its ownK073364 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
Descendant · cites it directly · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
Descendant · cites it directly · 493 of its ownK051024 Expedium Spine SystemDepuy Spine, Inc. · 2005
Descendant · cites it directly · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Descendant · cites it directly · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009

Showing 5 of 640 descendants. See all descendants

Descendants cleared per year

2005high 60 (2023) · low 1 (2005)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 640 · See all

K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008 · cites it directly538descendants
K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · cites it directly518descendants
K051024Expedium Spine SystemDepuy Spine, Inc. · 2005 · cites it directly493descendants
K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · cites it directly490descendants
K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · cites it directly462descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033901	Merlin Spine System	Depuy Spine, Inc.	2004	—
0 (this device)	K041119	Expedium Spine System	Depuy Spine, Inc.	2004	—
+1	K073364	Expedium 4.5MM Spine System	Depuy Spine, Inc.	2008	—
+1	K082942	Modfication to: Expedium Spine System	Depuy Spine, Inc.	2008	—
+1	K051024	Expedium Spine System	Depuy Spine, Inc.	2005	—
+1	K062174	Modification to Expedium Spine System	Depuy Spine, Inc.	2006	—
+1	K090230	Expedium Spine System	Depuy Spine, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	4	0
2008	10	0
2009	8	0
2010	9	0
2011	10	0
2012	30	0
2013	33	0
2014	29	0
2015	33	0
2016	29	0
2017	43	0
2018	43	0
2019	37	0
2020	41	0
2021	30	1
2022	39	0
2023	60	0
2024	54	0
2025	47	0
2026	48	0

FIG. 1 — Lineage of K041119, 2004–2026Source: 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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

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
*	K033901	Merlin Spine System Summary page 1 …Body Fixation PROPRIETARY NAME: Expedium Spine System PREDICATE DEVICES: Expedium Spine System (Merlin Spine System) k033901 DEVICE DESCRIPTION: Expedium Spine System components are designed to accept a 5.5mm rod and are av…	Depuy Spine, Inc.	2004	—

Also cleared against K033901: 34 other devices →

What descends from it? (640)

See all 640

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

Number	Device	Applicant	Decided	Descendants
K073364	Expedium 4.5MM Spine System	Depuy Spine, Inc.	2008	538
K082942	Modfication to: Expedium Spine System	Depuy Spine, Inc.	2008	518
K051024	Expedium Spine System	Depuy Spine, Inc.	2005	493
K062174	Modification to Expedium Spine System	Depuy Spine, Inc.	2006	490
K090230	Expedium Spine System	Depuy Spine, Inc.	2009	462
K090648	Viper 2 System	Depuy Spine, Inc.	2009	337
K073126	Expedium Spine System	Depuy Spine, Inc.	2007	304
K063772	Expedium Spine System	Depuy Spine, Inc.	2007	264
K113044	Synthes Mirs	Synthes Spine	2011	93
K121115	M.U.S.T Pedicle Screw System	Medacta International	2012	43

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K073364 (Depuy Spine, Inc., 2008) has gone furthest, with 538 descendants of its own.
34 other devices also cite its predicate K033901.

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	—

What is it indicated for?

The Expedium TM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041119 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041119: Expedium Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041119

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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