Graftys: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Graftys” (first 2008, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 178 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 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Graftys took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 4 | 4 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Orthopedic (4)
- Dental (1)
Most recent Graftys 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231714 | Graftys Quickset | MQV | 2023-07-12 | 30 |
| K093343 | GRAFTY QUICKSET | MQV | 2010-04-22 | 178 |
| K082498 | GRAFTYS HBS | MQV | 2009-02-25 | 180 |
| K082286 | BIOACTYS | LYC | 2009-02-24 | 197 |
| K073064 | GRAFTYS BCP | MQV | 2008-03-11 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Graftys.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Graftys?
FDA lists 5 510(k) clearances under the applicant name “Graftys” (first 2008, latest 2023), across 2 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 Graftys?
The median time from FDA receipt to decision across 510(k)s cleared under the name Graftys is 178 days.
Which FDA product codes appear under Graftys?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 4); LYC (Bone Grafting Material, Synthetic, 1).
Next steps
- See all 5 Graftys clearances with predicates and recalls
- Run predicate analysis for product code MQV, Graftys'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.