# K080353: LTM-T Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Apr 3, 2008 after 52 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 8 generations back to K921895 (1992). 40 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 45 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.
- K071065: Orthadapt Bioimplant, Pegasus Biologics, Inc. (2007) Summary page 1.

## Most influential descendants
- K091499: Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) (2009), 3 descendants of its own
- K103787: Medeor Matrix (2011), 2 descendants of its own
- K251690: Arthrex SpeedFLEX™ Implant (2025), 0 descendants of its own
- K133169: Meso Tendon Matrix (2013), 0 descendants of its own

## Indications for use
The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. LTM is intended for single patient, one time use only.

Source page: https://510kreport.com/device/K080353
Methodology: https://510kreport.com/methodology