510(k) · Cleared
ClearedPermacol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Science Laboratories, Plc · FTM Mesh, Surgical
Cleared on Oct 31, 2002 as substantially equivalent to K001738 (DePuy Orthopaedics, Inc., 2000) and 2 other predicates after a 213-day review. Its family tree reaches back 5 generations to 1992. 51 later devices descend from it.
- Decided
- Oct 31, 2002
- Review
- 213 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). 51 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 1 generation backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- This deviceK021056 PermacolTissue Science Laboratories, Plc · 2002
- Descendant · cites it directly · 41 of its ownK053562 Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006
- Descendant · 2 generations on · 28 of its ownK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- Descendant · 2 generations on · 17 of its ownK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- Descendant · 3 generations on · 11 of its ownK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- Descendant · 3 generations on · 9 of its ownK192112 FlexBand PlusInternational Life Sciences · 2019
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc · 2006 · cites it directly41descendants
- K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007 · 2 generations on28descendants
- K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008 · 2 generations on17descendants
- K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008 · 3 generations on11descendants
- K192112FlexBand PlusInternational Life Sciences · 2019 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −1 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K021056 | Permacol | Tissue Science Laboratories, Plc | 2002 | — |
| +1 | K053562 | Zimmer Collagen Repair Patch | Tissue Science Laboratories, Plc | 2006 | — |
| +2 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| +2 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| +3 | K072370 | Surgicraft Surgical Mesh System | Surgicraft, Ltd. | 2008 | — |
| +3 | K192112 | FlexBand Plus | International Life Sciences | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
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
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K001738 | Depuy Restore Orthobiologic Soft Tissue ImplantSummary page 1…Surgical Mesh Classification Name Surgical Mesh Predicate Devices DePuy, Inc.'s Restore@ Orthobiologic Soft Tissue Implant (K001738) ("Restore@"), Organogenesis, Inc.'s Fortaflex Surgical Mesh (KO11025) ("Fortaflex"); and Cook Biotech's Su… | 2000 |
| * | K011025 | Fortaflex Surgical Mesh | 2001 |
| * | K980431 | SurgisisSummary page 1…ic Soft Tissue Implant (K001738) ("Restore@"), Organogenesis, Inc.'s Fortaflex Surgical Mesh (KO11025) ("Fortaflex"); and Cook Biotech's SurgiSISTM(K980431) ("SurgiSISTM"). 1 "\DC - GG187/1 - #15039G4 v l Intended Use… | 1998 |
What descends from it? (51)
See all 514 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K053562 (Tissue Science Laboratories, Plc, 2006) has gone furthest, with 41 descendants of its own.
- 9 other devices also cite its predicate K001738.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 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?
Permacolm' - Crosslinked Porcine Dermal Collagen Surgical Mesh is indicated for use in the reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021056 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021056: Permacol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021056
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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