510(k) · Cleared
ClearedLTM-RC 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 Oct 19, 2007 as substantially equivalent to K070560 (Lifecell Corp., 2007) and 2 other predicates after a 91-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- Oct 19, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921895 (1992). 38 ancestors in all, the oldest K830889 (1983). 3 later devices descend 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 backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 2 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 1 generation backK021056 PermacolTissue Science Laboratories, Plc · 2002
- This deviceK071986 LTM-RC Surgical MeshLifecell Corp. · 2007
- Descendant · cites it directly · 2 of its ownK093799 Tornier Surgical MeshTornier, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK102788 Tornier Biofiber ScaffoldTornier, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK111337 Tornier Collagen Coated Biofiber ScaffoldTornier, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView 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 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K021056 | Permacol | Tissue Science Laboratories, Plc | 2002 | — |
| 0 (this device) | K071986 | LTM-RC Surgical Mesh | Lifecell Corp. | 2007 | — |
| +1 | K093799 | Tornier Surgical Mesh | Tornier, Inc. | 2010 | — |
| +2 | K102788 | Tornier Biofiber Scaffold | Tornier, Inc. | 2011 | — |
| +2 | K111337 | Tornier Collagen Coated Biofiber Scaffold | Tornier, Inc. | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (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…8876 Common or Usual Name Surgical Mesh Classification Name Surgical Mesh Predicate Devices LTM Surgical Mesh (K070560) Permacol® Implant (K050355) Permacol® (K021056) Intended Use / Indications for Use… | 2007 |
| * | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Summary page 1…Surgical Mesh Classification Name Surgical Mesh Predicate Devices LTM Surgical Mesh (K070560) Permacol® Implant (K050355) Permacol® (K021056) Intended Use / Indications for Use LTM-RC Surgical Mesh is intended fo… | 2005 |
| * | K021056 | PermacolSummary page 1…fication Name Surgical Mesh Predicate Devices LTM Surgical Mesh (K070560) Permacol® Implant (K050355) Permacol® (K021056) Intended Use / Indications for Use LTM-RC Surgical Mesh is intended for use as a soft tissue patch to… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093799 | Tornier Surgical Mesh | 2010 | 2 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 38 ancestors have a recall of any class.
- Of its descendants, K093799 (Tornier, Inc., 2010) has gone furthest, with 2 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. 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-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during rotator cuff repair surgery. Indications for use also include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material…
Read the full statement (138 words)
LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during rotator cuff repair surgery. Indications for use also 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 not intended to replace normal body structure or provide full mechanical strength to repair the rotator cuff. Sutures used to repair the tear and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.
LTM-RC is intended for single patient, one time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071986 · printed Nov 3, 2026
Cite this page
510(k) Report. “K071986: LTM-RC 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/K071986
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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