# K051647: Fortaderm Antimicrobial Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Nov 8, 2005 after 140 days
- Product code: FRO (Dressing, Wound, Drug)
- 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 K970566 (1997). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011026: Fortaderm Wound Dressing, Organogenesis, Inc. (2001)
- K024054: Xylos Xcell Antimicrobial Dressing, Xylos Corporation (2003) Summary page 1.

## Most influential descendants
- K251582: Redermax Antibacterial Wound Matrix (2026), 1 descendant of its own
- K261646: Redermax® Antibacterial Wound Matrix (2026), 0 descendants of its own
- K093351: Collawound Art (2010), 0 descendants of its own

## Indications for use
The FortaDermTM Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDermTM Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, and skin tears) and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K051647
Methodology: https://510kreport.com/methodology