510(k) Report

FDA applicant

Organogenesis, Inc.

Canton, MA13 decisions1997–20236 recalls

FDA records 13 decisions for Organogenesis, Inc. (Canton, MA) from 1997 to 2023: 12 510(k) clearances and 1 original PMA approval. Most are in product codes FTM (Mesh, Surgical) and KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 19 predicates, 8 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Organogenesis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12022: 12023: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2011

2007: 12009: 12010: 12011: 2
2007high 2 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Organogenesis, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Organogenesis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FTMMesh, Surgical6decisions
  • KGNWound Dressing With Animal-Derived Material (S)3decisions
  • FTLMesh, Surgical, Polymeric1decision
  • NPLBarrier, Animal Source, Intraoral1decision
  • FRODressing, Wound, Drug1decision
  • MGRDressing, Wound And Burn, Interactive1decision

Whose devices does it build on?

Its devices cite 19 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042809CuffpatchOrganogenesis, Inc. · 20046cite it
  • K011025Fortaflex Surgical MeshOrganogenesis, Inc. · 20016cite it
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 20025cite it
  • K970561Graft PatchOrganogenesis, Inc. · 19975cite it
  • K011026Fortaderm Wound DressingOrganogenesis, Inc. · 20013cite it
  • K021105Fortaflex Surgical MeshOrganogenesis, Inc. · 20022cite it

What has FDA decided for it lately?

  • K212579FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. · 2023
  • K220317PuraPly Micronized Wound Matrix (PuraPly MZ)Organogenesis, Inc. · 2022
  • K071555Fortagen Oral MembraneOrganogenesis, Inc. · 2007
  • K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc. · 2005
  • K042809CuffpatchOrganogenesis, Inc. · 2004
  • K021107Fortaflex Surgical SlingOrganogenesis, Inc. · 2002
  • K021105Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002

All 13 as Organogenesis, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • P950032Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living…Feb 21, 2011
  • P950032Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living…Jan 30, 2011
  • P950032Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100…Aug 2, 2010
  • P950032Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use…Sep 27, 2009
  • P950032Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc.…Dec 26, 2007
  • P950032Apligraf (Graftskin)Sep 29, 2006