510(k) · Cleared

Cleared

Lyoplant Onlay

K122791510(k) TraditionalCleared Jun 4, 2013265-day reviewClass II21 CFR 882.5910

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

Cleared on Jun 4, 2013 as substantially equivalent to K970851 (Aesculap, Inc., 1997) and 2 other predicates after a 265-day review. Its family tree reaches back 5 generations to 1995.

Decided: Jun 4, 2013
Review: 265 days
Class: Class II
Product code: GXQ
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K950956 (1995). 10 ancestors in all, the oldest K910555 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
4 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
3 generations backK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
2 generations backK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled
1 generation backK043427 Duragen II Dural Regeneration MatrixIntegra Lifesciences Corp. · 2005 · Recalled
This deviceK122791 Lyoplant OnlayAesculap, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K950956	Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute	Bio-Vascular, Inc.	1995	—
−4	K973706	Dura-Guard-Dural Repair Patch	Bio-Vascular, Inc.	1997	—
−3	K982180	Duragen Dural Graft Matrix	Integra Lifesciences Corp.	1999	1
−2	K032693	Duragen Plus Dural Graft Matrix	Integra Lifesciences Corp.	2003	1
−1	K043427	Duragen II Dural Regeneration Matrix	Integra Lifesciences Corp.	2005	2
0 (this device)	K122791	Lyoplant Onlay	Aesculap, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	1	0
1997	1	0
1998	1	0
2004	1	0

FIG. 1 — Lineage of K122791, 1995–2013Source: 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 GXQ? 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 GXQ device

#1 K251191 Collagen Dura Regeneration Membrane - Repairscore 12.2 · 7 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? (3)

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
*	K970851	Lyoplant Dura Substitute (Various) Summary page 3 …substitute. The device modifications described in this premarket notification are substantially equivalent to the predicate device Lyoplant Dura Substitute cleared via K970851, Suturable DuraGen cleared via K043427, and Durepair cleared via KO41000. Any technological differences between Lyoplant Onlay an…	Aesculap, Inc.	1997	—
*	K043427	Duragen II Dural Regeneration Matrix Summary page 3 …described in this premarket notification are substantially equivalent to the predicate device Lyoplant Dura Substitute cleared via K970851, Suturable DuraGen cleared via K043427, and Durepair cleared via KO41000. Any technological differences between Lyoplant Onlay and the predicate devices do not raise ne…	Integra Lifesciences Corp.	2005	2
*	K041000	Durepair Dura Regeneration Matrix Summary page 3 …es between Lyoplant Onlay and the predicate devices do not raise new types of safety or effectiveness issues. Lyoplant Onlay Lyoplant K970891 Suturable DuraGen Durepair K041000 (subject device) Aesculap K043247 Integra Medtronic LifeSciences Indications \| Lyoplant Onlay is Intended as a dura Indicated as…	Medtronic Neurosurgery	2004	—

Also cleared against K970851: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
4 of the 10 ancestors have a recall of any class.
2 other devices also cite its predicate K970851.

How does its category compare?

All GXQ devices

GXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GXQ

2in 2025

2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXQ

94in 2016

2007high 214 (2015) · low 94 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXQ

2in 2024

2007high 6 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXQ

61in 2025

2007high 114 (2020) · low 18 (2014)2025

MAUDE reports naming product code GXQ, 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	2	—	0	55
2008	0	—	0	43
2009	0	—	0	46
2010	1	—	6	36
2011	0	—	0	31
2012	2	—	0	38
2013	3	181	1	72
2014	1	—	0	18
2015	3	214	0	62
2016	3	94	0	58
2017	2	—	0	57
2018	0	—	0	94
2019	1	—	0	63
2020	0	—	0	114
2021	0	—	2	76
2022	1	—	0	59
2023	1	—	0	109
2024	0	—	2	55
2025	2	—	0	61
2026	0	—	0	—

What is it indicated for?

Lyoplant® Onlay is indicated as a dura substitute for the repair of the dura mater.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K122791 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122791: Lyoplant Onlay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122791

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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