Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Micofixation — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022-08-23 | 334 | 0 |
| K212841 | Pectus Blu Support Bar System | Biomet Micofixation | 2022-01-07 | 122 | 0 |
| K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021-01-28 | 64 | 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