510(k) · Cleared
ClearedLTM-T Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecell Corp. · FTL Mesh, Surgical, Polymeric
Cleared on Apr 3, 2008 as substantially equivalent to K070560 (Lifecell Corp., 2007) and 1 other predicate after a 52-day review. Its family tree reaches back 8 generations to 1992. 4 later devices descend from it.
- Decided
- Apr 3, 2008
- Review
- 52 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921895 (1992). 40 ancestors in all, the oldest K830889 (1983). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 2 generations backK043388 Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc. · 2005
- 1 generation backK071065 Orthadapt BioimplantPegasus Biologics, Inc. · 2007
- This deviceK080353 LTM-T Surgical MeshLifecell Corp. · 2008
- Descendant · cites it directly · 3 of its ownK091499 Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009
- Descendant · 2 generations on · 2 of its ownK103787 Medeor MatrixKensey Nash Corp. · 2011
- Descendant · 3 generations on · 0 of its ownK251690 Arthrex SpeedFLEX™ ImplantArthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK133169 Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical · 2013
Most influential descendants
Showing 4 of 4 · See all- K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp. · 2009 · cites it directly3descendants
- K103787Medeor MatrixKensey Nash Corp. · 2011 · 2 generations on2descendants
- K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc. · 2025 · 3 generations on0descendants
- K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −2 | K043388 | Pegasus Biologics Orthadapt Surgical Mesh | Pegasus Biologics, Inc. | 2005 | — |
| −1 | K071065 | Orthadapt Bioimplant | Pegasus Biologics, Inc. | 2007 | — |
| 0 (this device) | K080353 | LTM-T Surgical Mesh | Lifecell Corp. | 2008 | — |
| +1 | K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) | Kensey Nash Corp. | 2009 | — |
| +2 | K103787 | Medeor Matrix | Kensey Nash Corp. | 2011 | — |
| +3 | K251690 | Arthrex SpeedFLEX™ Implant | Arthrex, Inc. | 2025 | — |
| +3 | K133169 | Meso Tendon Matrix | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
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 | 3 | 0 |
| 1998 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2025 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K070560 | LRTM Surgical MeshSummary page 1…Classification Name Surgical Mesh Classification Class II Product Code FTM Predicate Devices LifeCell Corporation's LTM Surgical Mesh (K070560) Pegasus Biologics, Inc.'s OrthADAPTTM (K071065) Intended Use / Indications for Use The LifeCell Tissue M… | 2007 |
| * | K071065 | Orthadapt BioimplantSummary page 1…on Class II Product Code FTM Predicate Devices LifeCell Corporation's LTM Surgical Mesh (K070560) Pegasus Biologics, Inc.'s OrthADAPTTM (K071065) Intended Use / Indications for Use The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforce… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) | 2009 | 3 |
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 16 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 40 ancestors have a recall of any class.
- Of its descendants, K091499 (Kensey Nash Corp., 2009) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K070560.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The device is not intended to…
Read the full statement (130 words)
The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
LTM is intended for single patient, one time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080353 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080353: LTM-T Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080353
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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