# K251999: Promogran Prisma™ Collagen Matrix with ORC and Silver

- Pathway: 510(k) (Traditional)
- Applicant: Solventum Germany GmbH
- Decided: Mar 13, 2026 after 259 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: 6 generations back to K881854 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210135: PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing, 3M Healthcare Business Group (2022) Summary page 7.

## Indications for use
Indications for use WITHOUT ActiV.A.C. Therapy System Promogran Prisma™ Collagen Matrix with ORC and Silver, when used without ActiV.A.C Negative Pressure Wound Therapy System, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ Collagen Matrix with ORC and Silver may be used for the management of: • Diabetic ulcers • Venous ulcers • Pressure ulcers • Ulcers caused by mixed vascular etiologies • Full thickness and partial thickness wounds • Donor sites and other bleeding surface wounds • Abrasions • Traumatic wounds healing by secondary Intention • Dehisced surgical wounds Promogran Prisma™ Collagen Matrix with ORC and Silver may be used under compression therapy with healthcare professional supervision. Indications for Promogran Prisma™ Collagen Matrix with ORC and Silver when used in conjunction WITH the ActiV.A.C. Negative Pressure Wound Therapy System. Promogran Prisma™ Collagen Matrix with ORC and Silver, when used with the ActiV.A.C. Negative Pressure Wound Therapy System, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ Collagen Matrix with ORC and Silver with the ActiV.A.C. Negative Pressure Wound Therapy System may be used for the management of: • Venous ulcers • Pressure ulcers • Diabetic ulcers • Partial-thickness burns • Traumatic wounds healing by secondary intention • Dehisced surgical wounds Indications for Promogran Prisma™ Collagen Matrix with ORC and Silver, when used with V.A.C.® Peel and Place Dressings and the ActiV.A.C. Negative Pressure Therapy System. Promogran Prisma™ Collagen Matrix with ORC and Silver, when used with the V.A.C.® Peel and Place Dressings and ActiV.A.C. Negative Pressure Wound Therapy System, is intended for the management of exuding wounds. Under the supervision of a health care professional, the V.A.C.® Peel and Place Dressing and ActiV.A.C. Negative Pressure Therapy System may be used for the management of: • Venous ulcers • Pressure ulcers • Diabetic ulcers • Partial-thickness burns • Traumatic wounds healing by secondary intention • Dehisced surgical wounds Note: Compression therapy may only be used with Promogran Prisma™ Collagen Matrix with ORC and Silver under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ Collagen Matrix with ORC and Silver is used with V.A.C.® Peel and Place Dressing and ActiV.A.C.™ Negative Pressure Wound Therapy.

Source page: https://510kreport.com/device/K251999
Methodology: https://510kreport.com/methodology