510(k) · Cleared

Cleared

Oec/Rezaian Spinal Fixator

K841189510(k) TraditionalCleared May 16, 198457-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

Orthopedic Equipment Co., Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 16, 1984 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 2,426 devices in its family, counting itself, have a Class I recall. 2,425 later devices descend from it.

Decided: May 16, 1984
Review: 57 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 0

2,425 later devices descend from it, 9 citing it directly. 2 of the 2,426 devices in this family, counting this one, have a Class I recall.

This deviceK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
Descendant · cites it directly · 2,047 of its ownK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
Descendant · cites it directly · 1,867 of its ownK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
Descendant · cites it directly · 1,819 of its ownK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
Descendant · 2 generations on · 1,705 of its ownK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
Descendant · 3 generations on · 1,702 of its ownK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003

Showing 5 of 2,425 descendants. See all descendants

Descendants cleared per year

1999high 179 (2023) · low 0 (2000)2026

Class I recalls in this family

K051781 Graftcage TLX2 generations on · 2005
K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 2,425 · See all

K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · cites it directly2,047descendants
K990148Stackable Cage SystemDepuy Motech Acromed · 1999 · cites it directly1,867descendants
K003043Surgical Titanium Mesh SystemDepuyacromed · 2001 · cites it directly1,819descendants
K022793Tetris Spinal ImplantSignus Medical, LLC · 2003 · 2 generations on1,705descendants
K031757Peek Tetris Spinal ImplantSignus Medical, LLC · 2003 · 3 generations on1,702descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K841189	Oec/Rezaian Spinal Fixator	Orthopedic Equipment Co., Inc.	1984	—
+1	K021791	Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	—
+1	K990148	Stackable Cage System	Depuy Motech Acromed	1999	—
+1	K003043	Surgical Titanium Mesh System	Depuyacromed	2001	—
+2	K022793	Tetris Spinal Implant	Signus Medical, LLC	2003	—
+3	K031757	Peek Tetris Spinal Implant	Signus Medical, LLC	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	2	0
2002	4	0
2003	11	0
2004	22	0
2005	32	1
2006	24	0
2007	21	0
2008	33	0
2009	30	0
2010	36	0
2011	81	0
2012	96	0
2013	120	0
2014	142	0
2015	135	0
2016	150	0
2017	178	0
2018	161	0
2019	152	0
2020	152	0
2021	137	1
2022	137	0
2023	179	0
2024	150	0
2025	128	0
2026	111	0

FIG. 1 — Lineage of K841189, 1984–2026Source: 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.

2 devices in this family have a Class I recall. 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?

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

What descends from it? (2,425)

See all 2,425

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

Number	Device	Applicant	Decided	Descendants
K021791	Verte-Stack Spinal System	Medtronic Sofamor Danek	2002	2,047
K990148	Stackable Cage System	Depuy Motech Acromed	1999	1,867
K003043	Surgical Titanium Mesh System	Depuyacromed	2001	1,819
K020887	Ebi Ais Spine System	Ebi, L.P.	2002	1,622
K042571	Stryker Spine Avs TL Peek Spacer	Stryker Spine	2005	894
K051205	Stryker Spine Avs Asl Peek Spacer	Stryker Spine	2005	829
K111294	Santorini Spinal System	K2m, Inc.	2012	18
K192117	Small VBR™	Ulrich GmbH & Co. KG	2019	6
K181921	Solidity Vertebral Body Replacement	Ulrich Medical USA	2018	2

Has anything in its family been recalled? (2 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.

K051781Graftcage TLXOsteotech, Inc. · 2005 · 2 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K021791 (Medtronic Sofamor Danek, 2002) has gone furthest, with 2,047 descendants of its own.

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	—

https://510kreport.com/device/K841189 · printed Nov 4, 2026

Cite this page

510(k) Report. “K841189: Oec/Rezaian Spinal Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K841189

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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