510(k) · Cleared
ClearedLTM-Labaroscopic Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecell Corp. · OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Cleared on Aug 3, 2012 as substantially equivalent to K070560 (Lifecell Corp., 2007) after a 95-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Aug 3, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- OXK
- 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 deviceK121289 LTM-Labaroscopic Surgical MeshLifecell Corp. · 2012
- Descendant · cites it directly · 0 of its ownK130817 LTN - Laparoscopic Surgical MeshLifecell Corp. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130817LTN - Laparoscopic Surgical MeshLifecell Corp. · 2013 · 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) | K121289 | LTM-Labaroscopic Surgical Mesh | Lifecell Corp. | 2012 | — |
| +1 | K130817 | LTN - Laparoscopic Surgical Mesh | Lifecell Corp. | 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 |
|---|---|---|
| 2013 | 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 OXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…nchburg, NJ 08876 Common or Usual Name Surgical Mesh Classification Name Surgical Mesh Classification Class II Product Code FTM Predicate Devices LTM Surgical Mesh (K070560) - LifeCell Corporation 41 of 141… | 2007 |
| † | K103568 | Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh | 2010 |
| † | K092233 | Surgimesh XD | 2010 |
| † | K061445 | Surgimesh WN | 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 |
|---|---|---|---|
| K130817 | LTN - Laparoscopic Surgical Mesh | 2013 | 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 20 years and passes through 4 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, K130817 (Lifecell Corp., 2013) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K070560.
How does its category compare?
All OXK devicesOXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OXK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OXK
Too few OXK 510(k)s in any year since 2007 to give a median.
Recalls per year · OXK
No recall names OXK since 2007.
Adverse event reports per year · OXK
2in 2024
MAUDE reports naming product code OXK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
LTM-Lapardscopic 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 during open or laparoscopic procedures.
LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121289: LTM-Labaroscopic 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/K121289
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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