# K212579: FortiShield (Biosynthetic Wound Matrix)

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: May 2, 2023 after 624 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: 3 generations back to K082869 (2009). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082869: Awbat-S, Awbat-D, Awbat-M, Aubrey, Inc. (2009) Summary page 4.
- K901369: Green Label Biobrane II and Red Label Biobrane II, Sterling Drug, Inc. (1990) Summary page 4.
- K153678: PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove, Permeaderm, Inc. (2016) Summary page 4.

## Indications for use
FortiShield is indicated for: partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh’s, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds.

Source page: https://510kreport.com/device/K212579
Methodology: https://510kreport.com/methodology