# Sofradim Production

- Location (FDA's records): Trévoux, FR
- FDA decisions: 43 (1999–2026): 43 510(k) clearances
- Product codes: FTL (36), OTP (2), OWT (2), OTN (2), GCJ (1)
- 510(k) review time since 2016: median 89 days, against 105 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 90 (60 its own); citations of its devices by later devices: 78 (60 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 7 (https://510kreport.com/company/ethicon)
- Medical Device Consultants, Inc.: 6 (https://510kreport.com/company/medical-device-consultants)
- C.R. Bard, Inc.: 4 (https://510kreport.com/company/cr-bard)
- Davis & Geck, Inc.: 3 (https://510kreport.com/company/davis-geck)
- Cogent: 3 (https://510kreport.com/company/cogent)
- Mentor Corp.: 2 (https://510kreport.com/company/mentor)
- Davol, Inc.: 1 (https://510kreport.com/company/davol)
- Cousin Biotech Sas: 1 (https://510kreport.com/company/cousin-biotech)

## Firms that cite its devices most
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Aspide Medical: 2 (https://510kreport.com/company/aspide-medical)
- Gunze Limited: 2 (https://510kreport.com/company/gunze)
- Synovis Surgical Innovations: 2 (https://510kreport.com/company/synovis-surgical-innovations)
- Medtronic - Sofradim Production: 1 (https://510kreport.com/company/medtronic-sofradim-production)
- Tornier, Inc.: 1 (https://510kreport.com/company/tornier)
- Xylos Corporation: 1 (https://510kreport.com/company/xylos)
- Covidien UK Manufacturing, Ltd.: 1 (https://510kreport.com/company/covidien-uk-manufacturing)

## Its most-cited devices
- K040998: Modification to Parietex Composite (Pco) Mesh (2004), cited by 13
- K991400: Parietene Polypropylene Mesh (1999), cited by 8
- K081126: Parietex Composite Mono PM Mesh (2008), cited by 4
- K110816: Parietex Optimized Composite Mesh (Pco-Osx References) (2011), cited by 4
- K050187: Parietex Composite Pco-OS and Pco-OB Meshes (2005), cited by 3
- K120506: Parietex Composite Ventral Patch (2012), cited by 3

## Recent decisions
- K262443: Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) (Oct 16, 2026)
- K253956: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (May 21, 2026)
- K250869: Parietene™ Macroporous Mesh  (PPM5050 ) (Apr 23, 2025)
- K243315: ProGrip™ Self-Gripping Polypropylene Mesh (Jan 17, 2025)
- K233661: Transorb™ Self-Gripping Resorbable Mesh (Feb 13, 2024)
- K232373: Progrip™ Self-Gripping Polypropylene Mesh (Jan 18, 2024)
- K223218: Parietene Macroporous Mesh (Dec 2, 2022)
- K220586: Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (Jun 22, 2022)

Source page: https://510kreport.com/company/sofradim-production