510(k) · Cleared

Cleared

Kestrel™ Buttress Plate System

K181063510(k) TraditionalCleared Jul 13, 201881-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

Innovasis, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jul 13, 2018 as substantially equivalent to K092659 (Spinal USA, 2009) after an 81-day review. Its family tree reaches back 1 generation to 2009. 4 later devices descend from it.

Decided: Jul 13, 2018
Review: 81 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K092659 (2009). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK092659 Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25Spinal USA · 2009
This deviceK181063 Kestrel™ Buttress Plate SystemInnovasis, Inc. · 2018
Descendant · cites it directly · 2 of its ownK190584 CAYMAN LP Plate SystemK2m, Inc. · 2019
Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
Descendant · 3 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
Descendant · cites it directly · 0 of its ownK233360 Curiteva Thoracolumbar Plate SystemCuriteva, Inc. · 2024

Most influential descendants

Showing 4 of 4 · See all

K190584CAYMAN LP Plate SystemK2m, Inc. · 2019 · cites it directly2descendants
K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 3 generations on0descendants
K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K092659	Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25	Spinal USA	2009	—
0 (this device)	K181063	Kestrel™ Buttress Plate System	Innovasis, Inc.	2018	—
+1	K190584	CAYMAN LP Plate System	K2m, Inc.	2019	—
+2	K242361	OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…	Stryker Spine	2024	—
+3	K253545	Vulcan Spinal System	K2m, Inc.	2026	—
+1	K233360	Curiteva Thoracolumbar Plate System	Curiteva, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K181063, 2009–2026Source: 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
*	K092659	Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25 Summary page 4 …No.: 21CFR 888.3060 Class II Product Code: KWQ Review Panel: Orthopedic Predicate Device: K092659 - Precision Spine RCS Anterior Buttress Plate System This predicate has not been subject to a design-r…	Spinal USA	2009	—

Also cleared against K092659: 3 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K190584	CAYMAN LP Plate System	K2m, Inc.	2019	2
K233360	Curiteva Thoracolumbar Plate System	Curiteva, Inc.	2024	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?

Its one ancestor has no recall.
Of its descendants, K190584 (K2m, Inc., 2019) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K092659.

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. 2018, 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 Kestrel™ Buttress Plate System is indicated for use to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, or anterolateral spinal systems made of compatible materials. This device is not intended for load bearing applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181063 · printed Nov 5, 2026

Cite this page

510(k) Report. “K181063: Kestrel™ Buttress 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/K181063

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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