# K033523: Collagen-Orc Antimicrobial Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Ltd.
- Decided: Oct 21, 2004 after 349 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 K881854 (1988). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014129: Promogran Matrix Wound Dressing, Johnson & Johnson Medical, Ltd. (2002)
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002) Summary page 1.

## Most influential descendants
- K080949: Keratec Wound Dressings (2009), 3 descendants of its own
- K162759: KeraStat (R) Gel (2017), 1 descendant of its own
- K192386: KeraStat Cream (2020), 0 descendants of its own
- K182010: ProgenaMatrix (2019), 0 descendants of its own

## Indications for use
Collagen-ORC Antimicrobial Matrix is intended for the management of exuding wounds. Under the supervision of a health care professional, Collagen-ORC Antimicrobial Matrix may be used for the management of: Diabetic ulcers Venous ulcers Pressure ulcers Ulcers caused by mixed vascular etiologies Full-thickness & partial thickness wounds Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds Collagen-ORC Antimicrobial Matrix may be used under compression therapy with healthcare professional supervision,

Source page: https://510kreport.com/device/K033523
Methodology: https://510kreport.com/methodology