# K023328: Reinforced Absorbable Synthetic Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Center For Biomaterials and Advanced Technologies
- Decided: Dec 12, 2002 after 69 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 K842066 (1985). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844228: PDS Polydioxanone Mesh, ETHICON, Inc. (1985) Summary page 1.
- K014183: Afb (Absorbable Foam Buttress), J&J Corporate Biomaterials Center (2002)

## Indications for use
Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use.

Source page: https://510kreport.com/device/K023328
Methodology: https://510kreport.com/methodology