510(k) · Cleared

Recalled · Class II · 2016

Black Widow Anterior Buttress Plate

K081770510(k) TraditionalCleared Apr 2, 2009283-day reviewClass II21 CFR 888.3060Recalls 2

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

Omni Surgical, L.P. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 2, 2009 as substantially equivalent to K010911 (Macropore Biosurgery, Inc., 2001) after a 283-day review. Its family tree reaches back 1 generation to 2001. 20 later devices descend from it. It has been recalled 2 times.

Decided: Apr 2, 2009
Review: 283 days
Class: Class II
Product code: KWQ
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K010911 (2001). 20 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
This deviceK081770 Black Widow Anterior Buttress PlateOmni Surgical, L.P. · 2009
Descendant · cites it directly · 16 of its ownK133911 Genesys Spine Anterior Buttress Plate SystemGenesys Spine · 2014
Descendant · 2 generations on · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
Descendant · 3 generations on · 6 of its ownK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
Descendant · 3 generations on · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
Descendant · 3 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2014high 4 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 20 · See all

K133911Genesys Spine Anterior Buttress Plate SystemGenesys Spine · 2014 · cites it directly16descendants
K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · 2 generations on14descendants
K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021 · 3 generations on6descendants
K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · 3 generations on5descendants
K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · 3 generations on3descendants

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)	K081770	Black Widow Anterior Buttress Plate	Omni Surgical, L.P.	2009	—
+1	K133911	Genesys Spine Anterior Buttress Plate System	Genesys Spine	2014	—
+2	K192006	SIRION Lateral Lumbar Interbody System	Astura Medical, LLC	2020	—
+3	K202495	SIRION Lateral Lumbar Interbody Fusion	Astura Medical, LLC	2021	—
+3	K222554	EL CAPITAN Anterior Lumbar Interbody Fusion	Astura Medical	2023	—
+3	K231743	F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and…	Corelink, LLC	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2017	1	0
2018	2	0
2020	1	0
2021	1	0
2022	2	0
2023	4	0
2024	4	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K081770, 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

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
*	K010911	Macropore OS Spinal System Summary page 1 …y marketed devices which are substantially equivalent: The Black Widow Anterior Buttress Plate is substantially equivalent to the MacroPore OS Spinal System (K010911). 4. Description of the device: The Black Widow Anterior Buttress Plate is designed for preventing migration or…	Macropore Biosurgery, Inc.	2001	—

Also cleared against K010911: 7 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K133911	Genesys Spine Anterior Buttress Plate System	Genesys Spine	2014	16
K180755	Vail ALIF Buttress Plate System	Evolution Spine, LLC	2018	1
K180537	Zavation Buttress Plate System	Zavation Medical Products, LLC	2018	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 22, 2016	Class II	Z-0886-2017	Process change control	There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
Nov 22, 2016	Class II	Z-0887-2017	Process change control	There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K133911 (Genesys Spine, 2014) has gone furthest, with 16 descendants 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 Black Widow Anterior Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081770 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081770: Black Widow Anterior Buttress Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081770

Report an extraction error

Are you the manufacturer?

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