510(k) · Cleared
ClearedLTM-BPS 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 Nov 14, 2008 as substantially equivalent to K070560 (Lifecell Corp., 2007) and 2 other predicates after a 105-day review. Its family tree reaches back 6 generations to 1992. 14 later devices descend from it.
- Decided
- Nov 14, 2008
- Review
- 105 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). 14 later devices descend from it, 4 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 deviceK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
- Descendant · cites it directly · 11 of its ownK142326 HP Tissue MatrixLifecell Corporation · 2014
- Descendant · cites it directly · 9 of its ownK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- Descendant · 2 generations on · 4 of its ownK222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
- Descendant · 3 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K142326HP Tissue MatrixLifecell Corporation · 2014 · cites it directly11descendants
- K151083BioBridge Collagen MatrixFibralign Corporation · 2016 · cites it directly9descendants
- K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 2 generations on4descendants
- K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · 2 generations on3descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 3 generations on2descendants
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) | K082176 | LTM-BPS Surgical Mesh | Lifecell Corp. | 2008 | — |
| +1 | K142326 | HP Tissue Matrix | Lifecell Corporation | 2014 | — |
| +1 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| +2 | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +2 | K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023 | 3 |
| +3 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
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 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K070560 | LRTM Surgical MeshSummary page 1…Branchburg, NJ 08876 Common or Usual Name urdgical M--esh--- - Classification Name Surgical Mesh Predicate Devices LTM Surgical Mesh (K070560) PelviSoftTm (K03 1332) Permacolc0 (KO 1362 5) Intended Use / Indications for Use LTM-BPS Surgical Mesh is i… | 2007 |
| * | K031332 | Bard Pelvisoft Acellular Collagen BiomeshSummary page 1…r Usual Name urdgical M--esh--- - Classification Name Surgical Mesh Predicate Devices LTM Surgical Mesh (K070560) PelviSoftTm (K03 1332) Permacolc0 (KO 1362 5) Intended Use / Indications for Use LTM-BPS Surgical Mesh is intended for use as a soft tissue… | 2003 |
| * | K013625 | PermacolSummary page 2…LTM-BPS is substantially equivalent to legally marketed predicate devices, such as the LTM Surgical Mesh (K070560), PelviSoftTM (K031332) and Permacol® Implant (K013625) surgical mesh devices, LTM-BPS has the same intended uses and the same or similar indications, technological characteristics, an… | 2002 |
What descends from it? (14)
See all 144 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 16 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K142326 (Lifecell Corporation, 2014) has gone furthest, with 11 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. 2008, 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-BPS 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 which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.
LTM-BPS is intended for single patient, one time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082176: LTM-BPS 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/K082176
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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