510(k) · Cleared
ClearedPermacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Science Laboratories, Plc · PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Mar 9, 2005 as substantially equivalent to K992556 (Tissue Science Laboratories, Plc, 2000) and 1 other predicate after a 23-day review. Its family tree reaches back 4 generations to 1992. 54 later devices descend from it.
- Decided
- Mar 9, 2005
- Review
- 23 days
- Class
- Class III
- Product code
- PAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K921895 (1992). 13 ancestors in all, the oldest K830889 (1983). 54 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- This deviceK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- Descendant · cites it directly · 50 of its ownK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- Descendant · 2 generations on · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK142326 HP Tissue MatrixLifecell Corporation · 2014
- Descendant · 3 generations on · 9 of its ownK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- Descendant · 2 generations on · 7 of its ownK082103 LTM Wound DressingLifecell Corp. · 2008
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K070560LRTM Surgical MeshLifecell Corp. · 2007 · cites it directly50descendants
- K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · 2 generations on14descendants
- K142326HP Tissue MatrixLifecell Corporation · 2014 · 3 generations on11descendants
- K151083BioBridge Collagen MatrixFibralign Corporation · 2016 · 3 generations on9descendants
- K082103LTM Wound DressingLifecell Corp. · 2008 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| 0 (this device) | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| +1 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| +2 | K082176 | LTM-BPS Surgical Mesh | Lifecell Corp. | 2008 | — |
| +3 | K142326 | HP Tissue Matrix | Lifecell Corporation | 2014 | — |
| +3 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| +2 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 PAI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K992556 | PermacolSummary page 2…or Usual Name Surgical Mesh Classification Name Surgical Mesh kel @50 Predicate Devices Permacol® Crosslinked Porcine Dermal Collagen Surgical Mesh (KK992556) and Permacol® Surgical Implant (K043366) Intended Use Permucol® Surgical Implants are intended for use to support/reinforce so… | 2000 |
| * | K043366 | Permacol Surgical ImplantSummary page 2…on Name Surgical Mesh kel @50 Predicate Devices Permacol® Crosslinked Porcine Dermal Collagen Surgical Mesh (KK992556) and Permacol® Surgical Implant (K043366) Intended Use Permucol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permaco… | 2004 |
What descends from it? (54)
See all 543 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 13 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K070560 (Lifecell Corp., 2007) has gone furthest, with 50 descendants of its own.
- 7 other devices also cite its predicate K992556.
How does its category compare?
All PAI devicesPAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PAI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PAI
Too few PAI 510(k)s in any year since 2007 to give a median.
Recalls per year · PAI
No recall names PAI since 2007.
Adverse event reports per year · PAI
1in 2022
MAUDE reports naming product code PAI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.
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/K050355 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050355
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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