# K090823: Theraform Bilayer

- Pathway: 510(k) (Traditional)
- Applicant: Sewon Cellontech Co., Ltd.
- Decided: Oct 22, 2009 after 210 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881854 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021792: Bilayer Matrix Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 2.

## Indications for use
TheraFormTM Bilayer is intended for the management of wounds including: Partial and full-thickness wounds Pressure ulcers Venous ulcers Diabetic ulcers Chronic ulcers Surgical wounds (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence) Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) Draining wounds

Source page: https://510kreport.com/device/K090823
Methodology: https://510kreport.com/methodology