# K963228: Repliderm Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Orphan Medical, Inc.
- Decided: Dec 18, 1996 after 121 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: 1 generation back to K834343 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910944: Medifil, Biocore (1991) Summary page 3.
- K902345: Carrington Wound Dressing, Carrington Laboratories, Inc. (1990) Summary page 3.
- K920642: Micro-Coll Collagen Dermal Wound Spray, Micro-Collagen Pharmaceutics, Ltd. (1992) Summary page 3.
- K912565: Micro-Coll Collagen Wound Spray, Micro-Coll (1992) Summary page 3.
- K834343: Comfeel Powder, Coloplast A/S (1984) Summary page 3.

## Indications for use
Repliderm™ Wound Dressing cartilage powder is a collagen based powder intended for use in the management of pressure ulcers (stages I - IV), stasis ulcers, 1st and 2nd degree burns, diabetic ulcers, foot ulcers, post surgical incisions, radiation dermatitis, cuts, abrasions, irritations of the skin, partial thickness wounds and skin conditions associated with peristomal care. Repliderm™ Wound Dressing has also been shown to be useful for wound exudate absorption.

Source page: https://510kreport.com/device/K963228
Methodology: https://510kreport.com/methodology