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General product information only, not medical advice. Product use is decided by a clinician under the manufacturer’s instructions for use.
Short answer
PuraPly is a family of sterile, single-use, prescription collagen wound matrices made by Organogenesis Inc. Several versions exist: a plain collagen sheet, versions coated with the antimicrobial polyhexamethylenebiguanide hydrochloride (PHMB), and a micronized version (PuraPly MZ). U.S. device records describe each as a collagen product “intended for the management of wounds.”
Definition and scope
In FDA’s Global Unique Device Identification Database (AccessGUDID, read through openFDA on 2026-11-08), the labeler for every PuraPly record is Organogenesis Inc. The records mark the devices as prescription (Rx), single-use and sterile, and describe them as “packaged in sterile, sealed single pouches” and “supplied dry in sheet form.” This page covers what the product family is and how the public records classify it. It does not cover how a clinician applies it.
How the records describe the products
The GUDID descriptions differ by variant:
- PuraPly Wound Matrix is described as a “single-layer fenestrated sheet of collagen intended for the management of wounds.”
- PuraPly Antimicrobial Wound Matrix is described as a cross-linked extracellular matrix (ECM) scaffolding, a collagen sheet coated with PHMB, intended for the management of wounds.
- The XT record describes a collagen sheet coated with 0.1% PHMB.
For background on the material class, see the CASRAI guides on dermal matrices and on collagen-silver dressings, which compares another collagen-based dressing type with an antimicrobial component.
Variants and their listed regulatory codes
The table lists what FDA’s public databases show. Product codes and premarket numbers are as they appear in GUDID and openFDA records read on 2026-11-08; GUDID entries within the same brand family do not always carry the same product code or premarket number, so treat the table as a description of the records, not as a statement of what each product is cleared for.
| Variant (GUDID record) | Description in record | Premarket number listed | Product code listed |
|---|---|---|---|
| PuraPly Wound Matrix | Single-layer fenestrated collagen sheet | K011026 | KGN |
| PuraPly Antimicrobial Wound Matrix | Cross-linked ECM collagen sheet coated with PHMB | K051647 | FRO |
| PuraPly Antimicrobial Surgical Wound Matrix | Antimicrobial matrix record | K051647 | FRO |
| PuraPly Antimicrobial XT | Collagen sheet coated with 0.1% PHMB | None listed in one record; K051647 in another | KMF in one record; FRO in another |
| PuraPly MZ (Micronized Wound Matrix) | Micronized wound matrix | K220317 | KGN |
The openFDA 510(k) database lists K220317, “PuraPly Micronized Wound Matrix (PuraPly MZ),” from Organogenesis Inc., decided 2022-07-01 with the decision “Substantially Equivalent” (product code KGN). It also lists K051647, FortaDerm Antimicrobial Wound Dressing (Organogenesis, decided 2005-11-08, code FRO), and K011026, FortaDerm Wound Dressing (decided 2001-06-13, code KGN).
What the product codes KGN and FRO mean
FDA’s classification database names KGN “Wound Dressing With Animal-Derived Material(s)” and FRO “Dressing, Wound, Drug.” Both are listed with device class “U” (unclassified) and no regulation number. In practice, a plain collagen matrix record sits under KGN, while the PHMB-coated versions sit under a code whose name refers to a drug-containing dressing. That is why a buyer or reviewer comparing PuraPly records may see different codes within one brand.
Where it matters for clinics, supply teams and researchers
- Matching the right variant to a record. The plain, antimicrobial, XT and MZ versions have different descriptions and premarket numbers, so a supply list, formulary entry or protocol should name the exact variant, not just “PuraPly.”
- Prescription status. GUDID marks these devices Rx, single-use and sterile.
- Research context. ClinicalTrials.gov study NCT03070938, “PuraPly Antimicrobial Wound Matrix and Wound Management,” sponsored by Organogenesis, is a prospective observational case series with no experimental intervention. It started in 2016-11, is listed as completed, and enrolled 100 participants (actual). An observational case series records what happens in routine care; it does not compare the product with an alternative.
Related CASRAI pages on wound-care products include EpiFix and Puracyn, a separate product whose name is easily confused with PuraPly.
Common misunderstandings
- “PuraPly is one product.” The public records show a family with different compositions and listed premarket numbers.
- “Puracyn and PuraPly are related.” The names are similar; the records here list Organogenesis as the labeler of PuraPly, and the Puracyn guide covers a separate product.
- “A 510(k) number means clinical proof of healing.” A 510(k) decision of Substantially Equivalent concerns equivalence to a predicate device; it is not a finding about healing outcomes.
- “The registered study shows it works.” NCT03070938 is observational with no experimental arm, so it does not test efficacy against a comparator.
Sources
- openFDA device 510(k) API, search for PuraPly, read 2026-11-08.
- openFDA device classification API, product codes KGN and FRO, read 2026-11-08.
- AccessGUDID via the openFDA UDI API, brand name PuraPly, read 2026-11-08.
- ClinicalTrials.gov, NCT03070938, read 2026-11-08.
