# K092096: Endoform Dermal Template

- Pathway: 510(k) (Traditional)
- Applicant: Mesynthes, Ltd.
- Decided: Jan 21, 2010 after 191 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921895 (1992). 36 ancestors in all.
19 later devices descend from it; 6 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006)
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 1.
- K021637: Acell Ubm Lyophilized Wound Dressing, Acell, Inc. (2002) Summary page 1.
- K071425: Unite Biomatrix, Pegasus Biologics, Inc. (2007) Summary page 1.
- K014129: Promogran Matrix Wound Dressing, Johnson & Johnson Medical, Ltd. (2002) Summary page 1.
- K021792: Bilayer Matrix Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K073170: R-Port II Laparoscopic Access Device, Advanced Surgical Concepts (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own
- K200502: Myriad Particles (2021), 4 descendants of its own
- K231325: Corplex P / Theracor P / Allacor P (2024), 3 descendants of its own
- K190528: MariGen Wound Extra (2019), 3 descendants of its own
- K171231: Endoform Topical Matrix (2017), 3 descendants of its own

## Recalls of this device
- Nov 27, 2018 · Class II · Z-0378-2019: Potential for pouch seal failure
- Nov 27, 2018 · Class II · Z-0379-2019: Potential for pouch seal failure
- Nov 27, 2018 · Class II · Z-0377-2019: Potential for pouch seal failure

## Indications for use
The Endoform Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds: * 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, podiatric, wound dehiscence) * trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) * draining wounds

Source page: https://510kreport.com/device/K092096
Methodology: https://510kreport.com/methodology