Dermal Matrix: What It Is, Sources and FDA Pathways

General information only, not medical advice. Product choice and use belong to the treating clinician and the manufacturer’s instructions for use.

Short answer

A dermal matrix is a collagen-rich scaffold made from dermis, most often processed so that it contains no cells, and used as a graft in wound care and reconstructive surgery. After implantation, the host’s own cells and blood vessels populate it. There is no single regulatory category for these products: the same words describe items cleared as surgical mesh, as animal-derived wound dressings, or handled as human tissue.

Definition and scope

A 2023 review in Frontiers in Transplantation (Mohammadyari et al., doi:10.3389/frtra.2023.1133806) describes an acellular dermal matrix (ADM) as a biological graft that contains neither cellular nor antigenic components. The review says the scaffold is revascularized and repopulated by the host, and that ADMs are obtained from human, bovine and porcine tissue. The same paper notes that ADM is expensive and may be a reasonable choice only for some patients.

The field uses several names for overlapping products. The review lists “biological mesh (ADM)” in hernia repair, “acellular skin substitute” for burns, and “artificial dermis”. When you read a specification or a literature search, treat these as related labels, not separate technologies. The broader scaffold concept is covered in tissue engineering, and the cell type that populates a matrix is covered in fibroblast functions.

How dermal matrices are used in practice

The Frontiers review lists these applications: critical wounds such as diabetic wounds, implant-based breast reconstruction, abdominal and chest wall defects, palatoplasty, rhinoplasty, tendon repair, pelvic reconstruction and burns. Which product suits which use is set by each product’s labeling and clearance, not by the general term. This page deliberately gives no procedure steps.

Regulatory pathways: why “dermal matrix” is not one category

This is where supply and research-compliance staff most often get confused. Two different US frameworks can apply.

Human tissue: the 21 CFR 1271.10(a) test

Under 21 CFR 1271.10(a), a human cell, tissue, or cellular or tissue-based product (HCT/P) is regulated solely under section 361 of the Public Health Service Act only if it meets all of the following (summarized from the regulation as read on Cornell LII, 2026-11-08):

1. It is minimally manipulated.
2. It is intended for homologous use only, as reflected by labeling, advertising or other indications of the manufacturer’s objective intent.
3. Its manufacture does not involve combination with another article, except water, crystalloids, or a sterilizing, preserving or storage agent that raises no new clinical safety concern.
4. It has no systemic effect and does not depend on the metabolic activity of living cells for its primary function (with exceptions for autologous, family-related and reproductive use).

A product that fails any criterion is not covered by that provision alone. The terms “minimally manipulated” and “homologous use” are defined in 21 CFR 1271.3, so read the definitions there before classifying a specific product.

Devices: real 510(k) examples under different product codes

The openFDA 510(k) database (queried 2026-11-08, search term “dermal matrix”, six records) shows the same words under different product codes. The table lists every record returned.

K-number	Device name (as listed)	Applicant	Decision date	Product code
K050445	AMS Collagen Dermal Matrix	American Medical Systems, Inc.	2005-06-17	PAG
K073219	Collagen Dermal Matrix (two models)	American Medical Systems, Inc.	2008-04-10	FTM
K081272	Porcine surgical mesh; dermal matrix	Brennen Medical, LLC	2008-07-31	FTM
K111436	Porcine surgical mesh, porcine dermal matrix	Brennen Medical, LLC	2011-10-14	FTM
K113866	Porcine dermal xenografts, porcine dermal matrix	Brennen Medical, LLC	2012-03-23	KGN
K243071	Bovine Dermis Collagen Dermal Matrix	Collagen Matrix, Inc.	2024-12-19	KGN

In openFDA’s classification data, product code FTM is “Mesh, Surgical”, class 2, under 21 CFR 878.3300. KGN is “Wound Dressing With Animal-Derived Material(s)”; its class field is “U” in openFDA. A separate code, MDD (“Device, Dermal Replacement”), is listed as class 3. For how clearance works, see FDA 510(k) premarket notification, 510(k) summary and 510(k) vs De Novo.

Where it matters for labs, clinics and supply decisions

• Check the regulatory identity, not the name. Two products both called a dermal matrix can sit under a mesh code, a wound-dressing code, or the human-tissue framework, as the table shows.
• Check the source species. The review reports human, bovine and porcine origins; the 510(k) names above show porcine and bovine examples.
• Use the manufacturer’s instructions for use for indications, storage and handling. They are product-specific and are not generalized here.
• Cost is a recognised constraint. The review itself calls ADM expensive and suited to only some patients.

Common misunderstandings

• “Acellular means inert.” The review describes the scaffold as being revascularized and repopulated by host cells; it is a graft the body integrates, not a passive covering.
• “It is one product class.” Clearances above span at least two product codes, and human-derived products are assessed under the HCT/P criteria instead.
• “A 510(k) number proves the same indication.” Each clearance covers the indications in that submission; the search term matches only the device name.

FAQ

What is a dermal matrix?

A scaffold derived from dermis, usually acellular, that the host repopulates after grafting, per Mohammadyari et al. (2023).

Where does the tissue come from?

Human, bovine and porcine tissue, per the same review.

Is a dermal matrix an FDA-cleared device?

Some are. The openFDA records above show 510(k) clearances under codes FTM, KGN and PAG. Human-derived products may instead be regulated as HCT/Ps if all four criteria of 21 CFR 1271.10(a) are met.

Sources

• Mohammadyari F, et al. Acellular dermal matrix in reconstructive surgery: Applications, benefits, and cost. Front Transplant 2023;2. doi:10.3389/frtra.2023.1133806 (read 2026-11-08).
• 21 CFR 1271.10, Cornell LII (read 2026-11-08).
• openFDA device 510(k) and classification endpoints, open.fda.gov (data updated 2026-10-26; queried 2026-11-08).