510(k) · Cleared

Recalled · Class II · 2013

Eminent Spine Buttress (Fang) Plate System

K090415510(k) TraditionalCleared Jun 1, 2009103-day reviewClass II21 CFR 888.3060Recalls 1

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

Eminent Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jun 1, 2009 as substantially equivalent to K010911 (Macropore Biosurgery, Inc., 2001) after a 103-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it. It has been recalled once.

Decided: Jun 1, 2009
Review: 103 days
Class: Class II
Product code: KWQ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K010911 (2001). 5 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
This deviceK090415 Eminent Spine Buttress (Fang) Plate SystemEminent Spine · 2009
Descendant · cites it directly · 1 of its ownK180755 Vail ALIF Buttress Plate SystemEvolution Spine, LLC · 2018
Descendant · cites it directly · 1 of its ownK143065 NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015
Descendant · 2 generations on · 0 of its ownK261309 Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
Descendant · 2 generations on · 0 of its ownK222628 Life Spine ALIF Buttress Plate SystemLife Spine, Inc. · 2022
Descendant · cites it directly · 0 of its ownK173947 Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC · 2018 · Recalled

Most influential descendants

Showing 5 of 5 · See all

K180755Vail ALIF Buttress Plate SystemEvolution Spine, LLC · 2018 · cites it directly1descendant
K143065NuVasive ALIF Buttress Plate SystemNu Vasive, Incorporated · 2015 · cites it directly1descendant
K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026 · 2 generations on0descendants
K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc. · 2022 · 2 generations on0descendants
K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010911	Macropore OS Spinal System	Macropore Biosurgery, Inc.	2001	—
0 (this device)	K090415	Eminent Spine Buttress (Fang) Plate System	Eminent Spine	2009	—
+1	K180755	Vail ALIF Buttress Plate System	Evolution Spine, LLC	2018	—
+1	K143065	NuVasive ALIF Buttress Plate System	Nu Vasive, Incorporated	2015	—
+2	K261309	Palisades™ Buttress Plate System	Bethesda Medical Devices, LLC	2026	—
+2	K222628	Life Spine ALIF Buttress Plate System	Life Spine, Inc.	2022	—
+1	K173947	Lumbar Interbody Fusion System (OLLIF)	Advanced Research Medical, LLC	2018	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2018	2	0
2022	1	0
2026	1	0

FIG. 1 — Lineage of K090415, 2001–2026Source: 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? (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
*	K010911	Macropore OS Spinal System Summary page 1 …Buttress Plate PROPRIETARY NAME Eminent Spine Fang Plate System PREDICATE DEVICE(S) MacroPore OS Spinal System (K010911) SUBSTANTIAL EQUIVALENCE The Eminent Spine Fang Plate System was determined to be substantially equivalent to the MacroPore OS S…	Macropore Biosurgery, Inc.	2001	—

Also cleared against K010911: 7 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K180755	Vail ALIF Buttress Plate System	Evolution Spine, LLC	2018	1
K143065	NuVasive ALIF Buttress Plate System	Nu Vasive, Incorporated	2015	1
K173947	Lumbar Interbody Fusion System (OLLIF)	Advanced Research Medical, LLC	2018	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 20, 2013	Class II	Z-1418-2013	Labeling design	The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K180755 (Evolution Spine, LLC, 2018) has gone furthest, with 1 descendant of its own.
7 other devices also cite its predicate K010911.

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. 2009, 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 Eminent Spine Fang Plate System, in conjunction with traditional rigid fixation, is

intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as

a means to maintain the relative position of weak bony tissue such as allografts or

autografts. This device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090415 · printed Nov 5, 2026

Cite this page

510(k) Report. “K090415: Eminent Spine Buttress (Fang) Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090415

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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