510(k) · Cleared

Cleared

Permacol

K013625510(k) TraditionalCleared Jan 17, 200273-day reviewClass II21 CFR 878.3300

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

Tissue Science Laboratories, Plc · FTM Mesh, Surgical

Cleared on Jan 17, 2002 as substantially equivalent to K992556 (Tissue Science Laboratories, Plc, 2000) and 5 other predicates after a 73-day review. Its family tree reaches back 1 generation to 1997. 95 later devices descend from it.

Decided: Jan 17, 2002
Review: 73 days
Class: Class II
Product code: FTM
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K973379 (1997). 6 ancestors in all. 95 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK973379 Sterile Suprafoil Smooth Nylon Foil SheetsS. Jackson, Inc. · 1997
This deviceK013625 PermacolTissue Science Laboratories, Plc · 2002
Descendant · cites it directly · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
Descendant · 2 generations on · 50 of its ownK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
Descendant · cites it directly · 18 of its ownK060829 CosmatrixTei Biosciences, Inc. · 2006
Descendant · 2 generations on · 17 of its ownK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
Descendant · cites it directly · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

2004high 10 (2016) · low 0 (2020)2026

Most influential descendants

Showing 5 of 95 · See all

K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · cites it directly93descendants
K070560LRTM Surgical MeshLifecell Corp. · 2007 · 2 generations on50descendants
K060829CosmatrixTei Biosciences, Inc. · 2006 · cites it directly18descendants
K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · 2 generations on17descendants
K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · cites it directly14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973379	Sterile Suprafoil Smooth Nylon Foil Sheets	S. Jackson, Inc.	1997	—
0 (this device)	K013625	Permacol	Tissue Science Laboratories, Plc	2002	—
+1	K034039	Sis Plastic Surgery Matrix	Cook Biotech, Inc.	2004	—
+2	K070560	LRTM Surgical Mesh	Lifecell Corp.	2007	2
+1	K060829	Cosmatrix	Tei Biosciences, Inc.	2006	—
+2	K071807	Orthomend Soft Tissue Matrix	Tei Biosciences, Inc.	2007	4
+1	K082176	LTM-BPS Surgical Mesh	Lifecell Corp.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	3	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	2	0
2007	4	0
2008	5	0
2009	3	0
2010	3	0
2011	6	0
2012	4	0
2013	7	0
2014	6	0
2015	4	0
2016	10	0
2017	8	0
2018	2	0
2019	4	0
2021	2	0
2022	4	0
2023	2	0
2024	4	0
2025	10	0
2026	3	0

FIG. 1 — Lineage of K013625, 1997–2026Source: 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 FTM? 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 FTM device

#1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (6)

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
*	K992556	Permacol Summary page 2 …Permacol™ Classification Name Surgical Mesh Predicate Devices 1. Tissue Science Laboratories, PLC's Permacol™ Crosslinked Porcine Dermal Collagen Mesh (K992556) ("Permacol") 2. Tissue Technologies, Inc.’s Soft Form Facial Implant (K002071, K000849, K973462) (“Soft Form”) 3. Organogenesi…	Tissue Science Laboratories, Plc	2000	—
*	K002071	Softform Soft Tissue Augmentation Tube with Insertion Tool Modifications for Strands and… Summary page 2 …1. Tissue Science Laboratories, PLC's Permacol™ Crosslinked Porcine Dermal Collagen Mesh (K992556) ("Permacol") 2. Tissue Technologies, Inc.’s Soft Form Facial Implant (K002071, K000849, K973462) (“Soft Form”) 3. Organogenesis, Inc.’s Fortaflex Surgical Mesh (K011025) (“Fortaflex”) 4. S. Jackson, Inc.’s…	Tissue Technologies, Inc.	2000	—
*	K000849	Softform Facial Implant Summary page 2 …Science Laboratories, PLC's Permacol™ Crosslinked Porcine Dermal Collagen Mesh (K992556) ("Permacol") 2. Tissue Technologies, Inc.’s Soft Form Facial Implant (K002071, K000849, K973462) (“Soft Form”) 3. Organogenesis, Inc.’s Fortaflex Surgical Mesh (K011025) (“Fortaflex”) 4. S. Jackson, Inc.’s Sterile…	Tissue Technologies, Inc.	2000	—
*	K973462	Softform Facial Implant Summary page 2 …Laboratories, PLC's Permacol™ Crosslinked Porcine Dermal Collagen Mesh (K992556) ("Permacol") 2. Tissue Technologies, Inc.’s Soft Form Facial Implant (K002071, K000849, K973462) (“Soft Form”) 3. Organogenesis, Inc.’s Fortaflex Surgical Mesh (K011025) (“Fortaflex”) 4. S. Jackson, Inc.’s Sterile SupraFOIL…	Tissue Technologies, Inc.	1997	—
*	K011025	Fortaflex Surgical Mesh Summary page 2 …92556) ("Permacol") 2. Tissue Technologies, Inc.’s Soft Form Facial Implant (K002071, K000849, K973462) (“Soft Form”) 3. Organogenesis, Inc.’s Fortaflex Surgical Mesh (K011025) (“Fortaflex”) 4. S. Jackson, Inc.’s Sterile SupraFOIL Smooth Nylon Foil Sheets (K973379) (“SupraFOIL”) Intended Use Permacol…	Organogenesis, Inc.	2001	—
*	K973379	Sterile Suprafoil Smooth Nylon Foil Sheets Summary page 2 …0849, K973462) (“Soft Form”) 3. Organogenesis, Inc.’s Fortaflex Surgical Mesh (K011025) (“Fortaflex”) 4. S. Jackson, Inc.’s Sterile SupraFOIL Smooth Nylon Foil Sheets (K973379) (“SupraFOIL”) Intended Use Permacol™ is indicated for use to provide soft tissue repair or reinforcement in plastic and reco…	S. Jackson, Inc.	1997	—

Also cleared against K992556: 7 other devices →

What descends from it? (95)

See all 95

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

Number	Device	Applicant	Decided	Descendants
K034039	Sis Plastic Surgery Matrix	Cook Biotech, Inc.	2004	93
K060829	Cosmatrix	Tei Biosciences, Inc.	2006	18
K082176	LTM-BPS Surgical Mesh	Lifecell Corp.	2008	14
K081272	Porcine Surgical Mesh; Dermal Matrix	Brennen Medical, LLC	2008	6
K050246	Sis Dermal Augmentation Strand	Cook Biotech, Inc.	2005	4
K082079	Regen Collagen Scaffold (CS)	Regen Biologics, Inc.	2008	2
K112567	Biomerix Assure	Biomerix Corporation	2011	0
K112499	Biomerix Composite Surgical Mesh	Biomerix Corporation	2011	0
K063154	Facial Reconstructive Mesh (FRM)	Evera Medical, Inc.	2007	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?

None of the 6 ancestors has a recall.
Of its descendants, K034039 (Cook Biotech, Inc., 2004) has gone furthest, with 93 descendants of its own.
7 other devices also cite its predicate K992556.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTM

1in 2025

2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007high 316 (2015) · low 29 (2024)2026

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

Recalls per year · FTM

1in 2023

2007high 21 (2018) · low 0 (2009)2026

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

Adverse event reports per year · FTM

232in 2025

2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, 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	9	104	7	60
2008	9	86	1	141
2009	7	86	0	476
2010	2	—	1	197
2011	6	100	8	288
2012	4	66	0	467
2013	4	123	0	3,351
2014	8	153	0	1,093
2015	4	316	0	977
2016	7	88	0	509
2017	9	147	0	529
2018	2	—	21	357
2019	6	107	4	418
2020	4	59	1	457
2021	4	61	1	369
2022	0	—	0	375
2023	2	—	1	485
2024	3	29	0	383
2025	1	—	0	232
2026	1	—	0	—

What is it indicated for?

Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue

where weakness exists and for the surgical repair of damaged or ruptured soft

tissue membranes. It is specifically indicated for plastic and reconstructive surgery

of the face and head.

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/K013625 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013625: Permacol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013625

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026