# K071807: Orthomend Soft Tissue Matrix

- Pathway: 510(k) (Special)
- Applicant: Tei Biosciences, Inc.
- Decided: Aug 6, 2007 after 35 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 4 (0 Class I)
- 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.
17 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051766: Orthomend, Tei Biosciences, Inc. (2005) Summary page 2.
- K060829: Cosmatrix, Tei Biosciences, Inc. (2006) Summary page 2.
- K020455: Tissuemend Soft Tissue Repair Matrix, Tei Biosciences, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K071065: Orthadapt Bioimplant, Pegasus Biologics, Inc. (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K083898: Surgimend (2009), 9 descendants of its own
- K081272: Porcine Surgical Mesh; Dermal Matrix (2008), 6 descendants of its own
- K123128: Seri Surgical Scaffold (2013), 5 descendants of its own
- K140533: Galaflex Mesh (2014), 3 descendants of its own
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own

## Recalls of this device
- May 23, 2023 · Class II · Z-2070-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2083-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2069-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2071-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

## Indications for use
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: * Plastic and reconstructive surgery * Muscle flap reinforcement * Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias * 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. SurgiMend 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.

Source page: https://510kreport.com/device/K071807
Methodology: https://510kreport.com/methodology