510(k) · Cleared
Recalled · 2011LRTM Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecell Corp. · FTM Mesh, Surgical
Cleared on Jun 11, 2007 as substantially equivalent to K050355 (Tissue Science Laboratories, Plc, 2005) and 1 other predicate after a 104-day review. Its family tree reaches back 5 generations to 1992. 50 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 11, 2007
- Review
- 104 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921895 (1992). 22 ancestors in all, the oldest K830889 (1983). 50 later devices descend from it, 10 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 backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 1 generation backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- This deviceK070560 LRTM Surgical MeshLifecell Corp. · 2007
- Descendant · cites it directly · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
- Descendant · 2 generations on · 11 of its ownK142326 HP Tissue MatrixLifecell Corporation · 2014
- Descendant · 2 generations on · 9 of its ownK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- Descendant · cites it directly · 7 of its ownK082103 LTM Wound DressingLifecell Corp. · 2008
- Descendant · 2 generations on · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · cites it directly14descendants
- K142326HP Tissue MatrixLifecell Corporation · 2014 · 2 generations on11descendants
- K151083BioBridge Collagen MatrixFibralign Corporation · 2016 · 2 generations on9descendants
- K082103LTM Wound DressingLifecell Corp. · 2008 · cites it directly7descendants
- K132343Marigen Wound DressingKerecis Limited · 2013 · 2 generations on5descendants
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 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −1 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| 0 (this device) | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | — |
| +1 | K082176 | LTM-BPS Surgical Mesh | Lifecell Corp. | 2008 | — |
| +2 | K142326 | HP Tissue Matrix | Lifecell Corporation | 2014 | — |
| +2 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| +1 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| +2 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 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 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Summary page 1…Way Branchburg, NJ 08869 Common or Usual Name Surgical Mesh Classification Name Surgical Mesh Predicate Devices Permacol® Implant (K050355) Surgisis® (K034039) Intended Use / Indications for Use LTM Surgical Mesh (LTM) is intended for use a… | 2005 |
| * | K034039 | Sis Plastic Surgery MatrixSummary page 1…8869 Common or Usual Name Surgical Mesh Classification Name Surgical Mesh Predicate Devices Permacol® Implant (K050355) Surgisis® (K034039) Intended Use / Indications for Use LTM Surgical Mesh (LTM) is intended for use as a soft tissue patch to rein… | 2004 |
What descends from it? (50)
See all 5010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082176 | LTM-BPS Surgical Mesh | 2008 | 14 |
| K082103 | LTM Wound Dressing | 2008 | 7 |
| K130547 | Endoform Reconstructive Template | 2013 | 5 |
| K093524 | Pivit a/B ST and Pivit a/B ST-R | 2010 | 5 |
| K080353 | LTM-T Surgical Mesh | 2008 | 4 |
| K071986 | LTM-RC Surgical Mesh | 2007 | 3 |
| K123356 | Fortiva Porcine Dermis | 2013 | 1 |
| K121289 | LTM-Labaroscopic Surgical Mesh | 2012 | 1 |
| K152206 | SurgiPure XD Reconstructive Tissue Matrix | 2016 | 0 |
| K150712 | LTM-Perforated Surgical Mesh | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2011 | Not classified | Z-0178-2012 | PMA | The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market. |
| Jul 12, 2010 | Not classified | Z-2623-2010 | Employee error | Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K082176 (Lifecell Corp., 2008) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K050355.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
LTM Surgical Mesh 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.
LTM is intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070560: LRTM Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070560
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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