Organogenesis, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Organogenesis, Inc.” (first 1997, latest 2023), plus 1 PMA decision, across 6 product codes in 2 review panels. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 148 |
| 2023 | 1 | 624 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Organogenesis, Inc. took a median 386 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 6 | 6 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 3 | 3 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| MGR | Dressing, Wound And Burn, Interactive | 1 | 0 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
Review panels
- General and Plastic Surgery (12)
- Dental (1)
Most recent Organogenesis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix) | KGN | 2023-05-02 | 624 |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | KGN | 2022-07-01 | 148 |
| K071555 | FORTAGEN ORAL MEMBRANE | NPL | 2007-08-30 | 84 |
| K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | FRO | 2005-11-08 | 140 |
| K042809 | CUFFPATCH | FTM | 2004-11-02 | 21 |
| K021107 | FORTAFLEX SURGICAL SLING | FTM | 2002-05-15 | 40 |
| K021105 | FORTAFLEX SURGICAL MESH | FTM | 2002-05-10 | 35 |
| K020049 | FORTAFLEX SURGICAL MESH | FTM | 2002-03-18 | 70 |
| K011025 | FORTAFLEX SURGICAL MESH | FTM | 2001-08-24 | 141 |
| K011026 | FORTADERM WOUND DRESSING | KGN | 2001-06-13 | 70 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P950032 | PMA | APLIGRAF (GRAFTSKIN) | 1998-05-22 |
Recalls
6 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2011-02-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Organogenesis, Inc. is the lead sponsor of 11 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06618612: A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers (Recruiting, started 2024-08-19)
- NCT03286452: The RESPOND Registry (Completed, started 2017-02-21)
- NCT03070938: PuraPly™ Antimicrobial Wound Matrix and Wound Management (Completed, started 2016-11)
- NCT03070925: Prospective PuraPly™ AM Case Series Study (Completed, started 2016-11)
- NCT01327937: A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers (Completed, started 2011-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Organogenesis, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Organogenesis, Inc.” (first 1997, latest 2023), plus 1 PMA decision, across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Organogenesis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Organogenesis, Inc. is 77 days.
Which FDA product codes appear under Organogenesis, Inc.?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 6); KGN (Wound Dressing With Animal-Derived Material(S), 3); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 12 Organogenesis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Organogenesis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.