510(k) · Cleared

Cleared

LTN - Laparoscopic Surgical Mesh

K130817510(k) SpecialCleared Apr 17, 201323-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lifecell Corp. · OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects

Cleared on Apr 17, 2013 as substantially equivalent to K121289 (Lifecell Corp., 2012) after a 23-day review. Its family tree reaches back 7 generations to 1992.

Decided: Apr 17, 2013
Review: 23 days
Class: Class II
Product code: OXK
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
4 generations backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
3 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
2 generations backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
1 generation backK121289 LTM-Labaroscopic Surgical MeshLifecell Corp. · 2012
This deviceK130817 LTN - Laparoscopic Surgical MeshLifecell Corp. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K921895	Tissue Patch, Tissue Graft	Bio-Vascular, Inc.	1992	—
−6	K961810	Supple Peri-Guard Pericardium	Bio-Vascular, Inc.	1996	—
−5	K980431	Surgisis	Cook Biotech, Inc.	1998	—
−4	K043366	Permacol Surgical Implant	Tissue Science Laboratories, Plc	2004	—
−3	K050355	Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece…	Tissue Science Laboratories, Plc	2005	—
−2	K070560	LRTM Surgical Mesh	Lifecell Corp.	2007	2
−1	K121289	LTM-Labaroscopic Surgical Mesh	Lifecell Corp.	2012	—
0 (this device)	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

FIG. 1 — Lineage of K130817, 1992–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K121289	LTM-Labaroscopic Surgical Mesh Summary page 2 …evice has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-Laparoscopic Surgical Mesh (K 121289). The only change described in this submission is a minor modification to the Instructions for Use. There have been no changes m…	Lifecell Corp.	2012	—

What descends from it?

No later submission names this one as a predicate yet.

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 21 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.

How does its category compare?

All OXK devices

OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OXK

1in 2013

2007high 1 (2012) · low 0 (2007)2026

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

2007high 7 (2018) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	2
2016	0	—	6
2017	0	—	0
2018	0	—	7
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	2
2023	0	—	0
2024	0	—	2
2025	0	—	0
2026	0	—	—

What is it indicated for?

LTM-Laparoscopic 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/K130817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130817: LTN - Laparoscopic 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/K130817

Report an extraction error

Are you the manufacturer?

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