# K090812: Theraform Standard/Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Sewon Cellontech Co., Ltd.
- Decided: Jul 30, 2009 after 127 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 K881854 (1988). 10 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061407: Primatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2006) Summary page 2.

## Most influential descendants
- K112580: Collagen Wound Dressing (2012), 4 descendants of its own
- K182725: Apis (2019), 2 descendants of its own
- K222143: Apis (R), Veris (TM) (2023), 0 descendants of its own
- K211972: Omeza Collagen Matrix (2021), 0 descendants of its own
- K140456: Bio-Connekt Wound Matrix (2014), 0 descendants of its own

## Indications for use
TheraForm TMStandard / Sheet is intended for the management of wounds including: * Partial and full-thickness wounds * Pressure ulcers * Venous ulcers * Diabetic ulcers * Chronic 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 bums, and skin tears) * Draining wounds

Source page: https://510kreport.com/device/K090812
Methodology: https://510kreport.com/methodology