# K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo

- Pathway: 510(k) (Traditional)
- Applicant: Bionova Medical, Inc.
- Decided: Nov 13, 2023 after 136 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: 8 generations back to K973688 (1997). 76 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo, Bionova Medical, Inc. (2022) Summary page 5.
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm), Polynovo Biomaterials Pty, Ltd. (2017) Summary page 5.
- K112888: Meso Wound Matrix, Kensey Nash Corporation (2012) Summary page 5.

## Most influential descendants
- K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (2024), 1 descendant of its own
- K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (2024), 0 descendants of its own

## Indications for use
Foundation DRS Solo is indicated for the management of wounds including: * Full thickness and partial thickness wounds * Pressure ulcers * Venous ulcers * Ulcers caused by mixed vascular etiologies * Diabetic ulcers * Partial thickness burns (superficial second-degree burns) * Donor sites and other bleeding surface wounds * Abrasions * Trauma wounds (abrasions, lacerations, skin tears) * Dehisced wounds * Surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence) Foundation DRS Solo may be cut to size.

Source page: https://510kreport.com/device/K231937
Methodology: https://510kreport.com/methodology