# K051766: Orthomend

- Pathway: 510(k) (Abbreviated)
- Applicant: Tei Biosciences, Inc.
- Decided: Aug 11, 2005 after 42 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: 7 generations back to K921895 (1992). 31 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031188: Orthomend, Tei Biosciences, Inc. (2003) Summary page 2.
- K042809: Cuffpatch, Organogenesis, Inc. (2004) Summary page 2.
- K020049: Fortaflex Surgical Mesh, Organogenesis, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K083823: Securian Tissue Reinforcement Matrix (2009), 9 descendants of its own

## Indications for use
OrthoMend Soft Tissue Repair Matrix is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. OrthoMend Soft Tissue Repair Matrix 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. OrthoMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.

Source page: https://510kreport.com/device/K051766
Methodology: https://510kreport.com/methodology