# K142326: HP Tissue Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corporation
- Decided: Dec 23, 2014 after 125 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: 7 generations back to K921895 (1992). 25 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082176: LTM-BPS Surgical Mesh, Lifecell Corp. (2008) Summary page 4.

## Most influential descendants
- 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
- K261621: TekBrace Solo Soft Tissue Reinforcement Device (2026), 1 descendant of its own

## Indications for use
HPTM 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 tissue in plastic and reconstructive surgery. HPTM is intended for single patient, one-time use only.

Source page: https://510kreport.com/device/K142326
Methodology: https://510kreport.com/methodology