# K021637: Acell Ubm Lyophilized Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Acell, Inc.
- Decided: Dec 19, 2002 after 216 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: 5 generations back to K921895 (1992). 23 ancestors in all.
45 later devices descend from it; 5 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 1.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000)

## Most influential descendants
- K092096: Endoform Dermal Template (2010), 19 descendants of its own
- K092926: Acell Matristem Wound Sheet (2009), 14 descendants of its own
- K112409: Matristem Wound Matrix (2011), 7 descendants of its own
- K152721: Cytal Wound Matrix (2015), 6 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own

## Indications for use
The ACell UBM Lyophilized Wound Dressing is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor site/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K021637
Methodology: https://510kreport.com/methodology