# Organogenesis, Inc.

- Location (FDA's records): Canton, MA
- FDA decisions: 13 (1997–2023): 12 510(k) clearances and 1 original PMA approval
- Product codes: FTM (6), KGN (3), FTL (1), NPL (1), FRO (1), MGR (1)
- Predicates its devices cite: 19 (8 its own); citations of its devices by later devices: 30 (8 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)
- Cook Biotech, Inc.: 2 (https://510kreport.com/company/cook-biotech)
- Bio-Vascular, Inc.: 1 (https://510kreport.com/company/bio-vascular)
- Aubrey, Inc.: 1 (https://510kreport.com/company/aubrey)
- Sterling Drug, Inc.: 1 (https://510kreport.com/company/sterling-drug)
- Permeaderm, Inc.: 1 (https://510kreport.com/company/permeaderm)
- Colbar Lifescience, Ltd.: 1 (https://510kreport.com/company/colbar-lifescience)
- Ed. Geistlich Soehne AG Fuer Chemische Industrie: 1 (https://510kreport.com/company/ed-geistlich-soehne-ag-fuer-chemische-industrie)

## Firms that cite its devices most
- Kensey Nash Corp.: 4 (https://510kreport.com/company/kensey-nash)
- Tissue Science Laboratories, Plc: 3 (https://510kreport.com/company/tissue-science-laboratories)
- Artimplant AB: 2 (https://510kreport.com/company/artimplant)
- Tei Biosciences, Inc.: 2 (https://510kreport.com/company/tei-biosciences)
- Collamatrix Co., Inc.: 2 (https://510kreport.com/company/collamatrix)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Genoss Co., Ltd.: 1 (https://510kreport.com/company/genoss)

## Its most-cited devices
- K042809: Cuffpatch (2004), cited by 6
- K011025: Fortaflex Surgical Mesh (2001), cited by 6
- K020049: Fortaflex Surgical Mesh (2002), cited by 5
- K970561: Graft Patch (1997), cited by 5
- K011026: Fortaderm Wound Dressing (2001), cited by 3
- K021105: Fortaflex Surgical Mesh (2002), cited by 2

## Recent decisions
- K212579: FortiShield (Biosynthetic Wound Matrix) (May 2, 2023)
- K220317: PuraPly Micronized Wound Matrix (PuraPly MZ) (Jul 1, 2022)
- K071555: Fortagen Oral Membrane (Aug 30, 2007)
- K051647: Fortaderm Antimicrobial Wound Dressing (Nov 8, 2005)
- K042809: Cuffpatch (Nov 2, 2004)
- K021107: Fortaflex Surgical Sling (May 15, 2002)
- K021105: Fortaflex Surgical Mesh (May 10, 2002)
- K020049: Fortaflex Surgical Mesh (Mar 18, 2002)

Source page: https://510kreport.com/company/organogenesis