# K011026: Fortaderm Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Jun 13, 2001 after 70 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
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061474: Collawound Dressing (2006), 3 descendants of its own
- K051647: Fortaderm Antimicrobial Wound Dressing (2005), 3 descendants of its own
- K090894: Collawound Wound Dressing (2009), 2 descendants of its own
- K251582: Redermax Antibacterial Wound Matrix (2026), 1 descendant of its own
- K162348: ABCcolla Collagen Matrix (2017), 1 descendant of its own

Source page: https://510kreport.com/device/K011026
Methodology: https://510kreport.com/methodology