510(k) · Cleared

Recalled · Class II · 2013

Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane

K992216510(k) SpecialCleared Jul 26, 199925-day reviewClass II21 CFR 872.3930Recalls 1

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

Integra Lifesciences Corp. · LYC Bone Grafting Material, Synthetic

Cleared on Jul 26, 1999 as substantially equivalent to K924408 (Colla-Tec, Inc., 1995) after a 25-day review. Its family tree reaches back 1 generation to 1995. 59 later devices descend from it. It has been recalled once.

Decided: Jul 26, 1999
Review: 25 days
Class: Class II
Product code: LYC
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K924408 (1995). 59 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
This deviceK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999
Descendant · cites it directly · 58 of its ownK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
Descendant · 2 generations on · 53 of its ownK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
Descendant · 2 generations on · 23 of its ownK112572 Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011
Descendant · 3 generations on · 21 of its ownK122894 Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit…Geistlich Pharma AG · 2013
Descendant · 2 generations on · 16 of its ownK061244 MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2004high 8 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 59 · See all

K042197Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone RegenerationEd. Geistlich Soehne AG Fuer Chemische Industrie · 2004 · cites it directly58descendants
K050446Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005 · 2 generations on53descendants
K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011 · 2 generations on23descendants
K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG · 2013 · 3 generations on21descendants
K061244MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006 · 2 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924408	Colla-Tec Absorbable Collagen Membrane	Colla-Tec, Inc.	1995	2
0 (this device)	K992216	Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen…	Integra Lifesciences Corp.	1999	—
+1	K042197	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2004	—
+2	K050446	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2005	—
+2	K112572	Geistlich Combi-Kit Collegen	Geistlich Pharma AG	2011	—
+3	K122894	Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen…	Geistlich Pharma AG	2013	—
+2	K061244	Mucograft	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2008	1	0
2009	4	0
2010	3	0
2011	5	0
2012	1	0
2013	4	0
2014	5	0
2015	1	0
2016	1	0
2017	3	0
2018	2	0
2019	1	0
2020	3	0
2021	3	0
2022	2	0
2023	3	0
2024	3	0
2025	8	0
2026	2	0

FIG. 1 — Lineage of K992216, 1995–2026Source: 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 LYC? 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 LYC device

#1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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
*	K924408	Colla-Tec Absorbable Collagen Membrane Summary page 1 …tially equivalent in function and intended use to the product, BioMend™ Absorbable Collagen Membrane which has been cleared to market under Premarket Notification 510(k) K924408. Device Description: BioMend Extend" Absorbable Collagen Membrane is a white, compressed, non-friable matrix fabricated from co…	Colla-Tec, Inc.	1995	2

What descends from it? (59)

See all 59

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

Number	Device	Applicant	Decided	Descendants
K042197	Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration	Ed. Geistlich Soehne AG Fuer Chemische Industrie	2004	58
K100695	Colladental Barrier	Collamatrix, Inc.	2013	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 28, 2013	Class II	Z-1299-2013	Process control	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K042197 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2004) has gone furthest, with 58 descendants of its own.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007high 267 (2025) · low 73 (2008)2026

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

Recalls per year · LYC

1in 2018

2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · LYC

2in 2025

2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, 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	13	80	0	23
2008	8	73	0	25
2009	14	100	1	25
2010	13	164	2	28
2011	9	224	0	21
2012	5	120	2	10
2013	2	—	0	12
2014	1	—	0	9
2015	0	—	0	14
2016	2	—	2	140
2017	0	—	0	19
2018	0	—	1	14
2019	0	—	0	15
2020	3	156	0	5
2021	0	—	0	12
2022	2	—	0	6
2023	0	—	0	9
2024	0	—	0	6
2025	3	267	0	2
2026	3	266	0	—

What is it indicated for?

BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is

indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of

the periodontal apparatus.

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/K992216 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992216: Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992216

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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