# K070560: LRTM Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Jun 11, 2007 after 104 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921895 (1992). 22 ancestors in all.
50 later devices descend from it; 10 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150, Tissue Science Laboratories, Plc (2005) Summary page 1.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 1.

## Most influential descendants
- K082176: LTM-BPS Surgical Mesh (2008), 14 descendants of its own
- K142326: HP Tissue Matrix (2014), 11 descendants of its own
- K151083: BioBridge Collagen Matrix (2016), 9 descendants of its own
- K082103: LTM Wound Dressing (2008), 7 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own

## Recalls of this device
- Jul 13, 2011 · Not classified · Z-0178-2012: The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market.
- Jul 12, 2010 · Not classified · Z-2623-2010: Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.

## Indications for use
LTM 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. LTM is intended for single patient use only.

Source page: https://510kreport.com/device/K070560
Methodology: https://510kreport.com/methodology