510(k) · Cleared
ClearedFortiva Porcine Dermis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rti Biologics, Inc. · FTM Mesh, Surgical
Cleared on Mar 5, 2013 as substantially equivalent to K070560 (Lifecell Corp., 2007) after a 125-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Mar 5, 2013
- Review
- 125 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921895 (1992). 23 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 2 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- 1 generation backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- This deviceK123356 Fortiva Porcine DermisRti Biologics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK142070 Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −2 | 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 |
| 0 (this device) | K123356 | Fortiva Porcine Dermis | Rti Biologics, Inc. | 2013 | — |
| +1 | K142070 | Fortiva Porcine Dermis, Tutoplast Porcine Dermis | Rti Surgical, Inc. | 2014 | — |
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 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K070560 | LRTM Surgical MeshSummary page 1…surgical (21 CFR 878.3300, product code FTM) Substantial Equivalence: The proposed device issubstantially equivalent to the predicate device StratticeO (K070560) in intended use, material, design, and function. Description: The proposed device isan implantable surg… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142070 | Fortiva Porcine Dermis, Tutoplast Porcine Dermis | 2014 | 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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K142070 (Rti Surgical, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K070560.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
The device 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. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123356: Fortiva Porcine Dermis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123356
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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