# K082176: LTM-BPS Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Nov 14, 2008 after 105 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921895 (1992). 24 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070560: LRTM Surgical Mesh, Lifecell Corp. (2007) Summary page 1.
- K031332: Bard Pelvisoft Acellular Collagen Biomesh, C.R. Bard, Inc. (2003) Summary page 1.
- K013625: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 2.

## Most influential descendants
- K142326: HP Tissue Matrix (2014), 11 descendants of its own
- K151083: BioBridge Collagen Matrix (2016), 9 descendants of its own
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K230316: FlexBand; FlexPatch; FlexBand Plus (2023), 3 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K082176
Methodology: https://510kreport.com/methodology