# K071986: LTM-RC Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Oct 19, 2007 after 91 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). 38 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 42 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.
- K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150, Tissue Science Laboratories, Plc (2005) Summary page 1.
- K021056: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.

## Most influential descendants
- K093799: Tornier Surgical Mesh (2010), 2 descendants of its own
- K102788: Tornier Biofiber Scaffold (2011), 1 descendant of its own
- K111337: Tornier Collagen Coated Biofiber Scaffold (2012), 0 descendants of its own

## Indications for use
LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during rotator cuff repair surgery. Indications for use also 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. The device is not intended to replace normal body structure or provide full mechanical strength to repair the rotator cuff. Sutures used to repair the tear and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair. LTM-RC is intended for single patient, one time use only.

Source page: https://510kreport.com/device/K071986
Methodology: https://510kreport.com/methodology