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General information only, not medical advice. This page does not describe clinical technique; follow the manufacturer’s labeling and the treating clinician’s direction.
Short answer
EpiFix is a MiMedx brand of placental tissue allograft made from dehydrated human amnion/chorion membrane (DHACM). The manufacturer describes it as a terminally sterilized, shelf-stable sheet or mesh product used as a protective barrier on wounds. Price and Medicare coverage are not fixed properties of the product: they depend on the payer, the setting and current coverage policy, so this page points to where those documents live instead of quoting numbers.
Definition and scope
An allograft is tissue taken from one human donor and used in another person. According to the MiMedx EpiFix product page (read 2026-11-07), EpiFix is composed of dehydrated human amnion/chorion membrane, processed with the company’s patented PURION method, which the manufacturer says preserves the extracellular matrix including regulatory factors. The tissue comes from healthy, consenting mothers after live Caesarean births in the United States, and the finished product is terminally sterilized.
The manufacturer lists sheet and mesh (fenestrated) forms in several sizes, so a purchasing or inventory record needs the exact configuration from the product labeling, not just the brand name. These are descriptions from the manufacturer, not independent performance findings.
How it is used in practice
How is EpiFix applied?
Application is performed by a clinician according to the manufacturer’s instructions for use, and the technique is deliberately not described here. The manufacturer states that EpiFix is compatible with negative pressure wound therapy (NPWT) and hyperbaric oxygen therapy (HBOT), and gives clinical-use examples that include acute and chronic wounds, debridements, dehisced wounds, diabetic foot ulcers, venous leg ulcers, pressure ulcers and Mohs surgical repair. Anyone handling the product should work from the current labeling supplied with it.
Storage and shelf life
MiMedx describes the product as shelf-stable with a 5-year shelf life. The product page does not give a storage temperature, so receiving staff should take storage conditions and expiry from the package label and IFU rather than from a general rule.
Why it is not a typical device purchase: the 21 CFR 1271.10 test
Placental membranes are human cells, tissues, and cellular and tissue-based products (HCT/Ps). Under 21 CFR 1271.10(a) (Cornell LII text, read 2026-11-07), an HCT/P is regulated solely under section 361 of the Public Health Service Act and Part 1271 if it meets all four criteria below. The regulation is the test for that pathway; it does not itself describe what applies to a product that fails a criterion.
| Criterion in 1271.10(a) | What the regulation says |
|---|---|
| (1) Minimal manipulation | The HCT/P is minimally manipulated. |
| (2) Homologous use | Intended for homologous use only, as reflected by labeling, advertising or other indications of the manufacturer’s objective intent. |
| (3) No combination | Manufacture does not combine the cells or tissues with another article, except water, crystalloids, or a sterilizing, preserving or storage agent that raises no new clinical safety concerns. |
| (4) Systemic effect | Either no systemic effect and not dependent on the metabolic activity of living cells for its primary function; or, if it has one, it is autologous, for a first- or second-degree blood relative, or for reproductive use. |
This is a checklist for understanding why tissue products and 510(k)-cleared dressings can sit on different regulatory paths. It is not a statement about EpiFix’s own status; the manufacturer’s regulatory documentation is where that is stated. For the device pathway, see FDA medical device regulations and FDA clearance vs approval.
Related concepts
- Wound dressings. Ordinary dressings are devices; see what a wound dressing is.
- Tissue banks. Organisations that recover, process and distribute donated tissue are covered in tissue bank.
- Coding and coverage. Supplies are identified through the HCPCS system (HCPCS Level II codes) and Medicare coverage is set by national or local determinations (NCD vs LCD).
Where it matters for clinics and supply staff: a documents checklist
Each item below is something the sources above show the manufacturer or regulation actually produces. Ask for it from the manufacturer; do not assume it from a general rule.
- Exact configuration: sheet or mesh form and size, from the labeling (the manufacturer lists several).
- Storage and expiry: the temperature and shelf-life statement on the label and IFU (the product page gives only “shelf-stable” and 5 years).
- Compatibility statements: the labeled position on use with NPWT and HBOT.
- Reimbursement guides: MiMedx publishes a Medicare physician fee schedule billing guide and a CY2026 hospital outpatient guide, and directs questions to its Field Reimbursement Manager line (855.882.8480, per its reimbursement page, read 2026-11-07).
- Regulatory basis: the manufacturer’s statement of how the product is regulated, read against the four criteria above.
Common misunderstandings
- “Placental allograft” does not mean “510(k)-cleared device.” The pathway depends on the 1271.10 criteria and the product’s labeling.
- A brand name is not a specification. Sheet, mesh and size variants are separate configurations.
- Shelf-stable is not a storage instruction. Follow the label.
- Manufacturer examples are not coverage. A listed use does not mean a payer covers it.
FAQ
How much does EpiFix cost?
No price is given here. Cost depends on the configuration and size, the purchaser’s contract and the setting, and should come from a manufacturer or distributor quote.
Is EpiFix covered by Medicare?
Medicare coverage is set through national and local coverage determinations and payment rules that change over time, and it depends on the setting and indication. MiMedx offers a Medicare billing guide for the physician fee schedule and hospital outpatient settings; check the current Medicare Coverage Database and your contractor’s policy for the date of service. See Medicare coverage determinations for how NCDs and LCDs work.
What are MiMedx grafts made of?
EpiFix is made of dehydrated human amnion/chorion membrane (DHACM) from donated placental tissue, per the manufacturer. MiMedx markets other products too; each has its own labeling and composition.
How is EpiFix applied?
By a clinician following the manufacturer’s IFU. Step-by-step technique is outside the scope of this page.
Sources
- MiMedx, EpiFix product page, https://www.mimedx.com/epifix (read 2026-11-07).
- MiMedx, Reimbursement page, https://www.mimedx.com/reimbursement (read 2026-11-07).
- 21 CFR 1271.10, Cornell Legal Information Institute, https://www.law.cornell.edu/cfr/text/21/1271.10 (read 2026-11-07).
