Osartis GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Osartis GmbH” (first 2019, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 117 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2019 | 2 | 90 |
| 2020 | 0 | — |
| 2021 | 3 | 59 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 237 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osartis GmbH took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOD | Bone Cement | 5 | 5 |
| MBB | Bone Cement, Antibiotic | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Osartis GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | MBB | 2024-11-20 | 237 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | LOD | 2021-05-18 | 264 |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | LOD | 2021-03-19 | 59 |
| K210120 | BonOs HV, BonOs MV, BonOs LV | LOD | 2021-03-19 | 59 |
| K192394 | Hi-Fatigue Bone Cement | LOD | 2019-12-02 | 90 |
| K192379 | Hi-Fatigue G Bone Cement | LOD | 2019-11-27 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Osartis GmbH.
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 Osartis GmbH?
FDA lists 6 510(k) clearances under the applicant name “Osartis GmbH” (first 2019, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Osartis GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osartis GmbH is 90 days. Since 2017: 90 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Osartis GmbH?
The most frequent FDA product codes under this applicant name are LOD (Bone Cement, 5); MBB (Bone Cement, Antibiotic, 1).
Next steps
- See all 6 Osartis GmbH clearances with predicates and recalls
- Run predicate analysis for product code LOD, Osartis GmbH'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.