# K083898: Surgimend

- Pathway: 510(k) (Special)
- Applicant: Tei Biosciences, Inc.
- Decided: Feb 4, 2009 after 37 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921895 (1992). 41 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071807: Orthomend Soft Tissue Matrix, Tei Biosciences, Inc. (2007) Summary page 2.

## Cited in the summary but kept off the family tree
- K020488: Careside Trglyceride, Careside, Inc. (2002). Our reading of the summary gave K020488, FDA’s number for Careside Trglyceride (Careside, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “TissueMend”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K123128: Seri Surgical Scaffold (2013), 5 descendants of its own
- K140533: Galaflex Mesh (2014), 3 descendants of its own
- K161092: GalaSHAPE 3D (2016), 1 descendant of its own
- K202425: SurgiLattice scaffold (2021), 0 descendants of its own
- K172545: SERI Contour (2017), 0 descendants of its own

## Recalls of this device
- May 23, 2023 · Class II · Z-2074-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2075-2023: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- May 23, 2023 · Class II · Z-2072-2023: 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

Source page: https://510kreport.com/device/K083898
Methodology: https://510kreport.com/methodology