Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osartis GmbH — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
264 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | 2024-11-20 | 237 | 0 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021-05-18 | 264 | 0 |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | 2021-03-19 | 59 | 0 |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | 2021-03-19 | 59 | 0 |
| K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | 2019-12-02 | 90 | 0 |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | 2019-11-27 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda