# K031188: Orthomend

- Pathway: 510(k) (Abbreviated)
- Applicant: Tei Biosciences, Inc.
- Decided: Jun 27, 2003 after 73 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: 5 generations back to K921895 (1992). 25 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020455: Tissuemend Soft Tissue Repair Matrix, Tei Biosciences, Inc. (2002)
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000)

## Most influential descendants
- K051766: Orthomend (2005), 35 descendants of its own
- K071807: Orthomend Soft Tissue Matrix (2007), 17 descendants of its own
- K060989: Tissuemend Soft Tissue Repair Matrix (2006), 13 descendants of its own
- K063648: Surgi-Wrap Mast Tendon Sheet (2007), 12 descendants of its own
- K072190: Ortho-Wrap Bioresorbable Sheet (2008), 10 descendants of its own

## Indications for use
OrthoMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.

Source page: https://510kreport.com/device/K031188
Methodology: https://510kreport.com/methodology