Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Microfixation, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
147 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | Biomet Microfixation, Inc. | 2011-11-29 | 147 | 0 |
| K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM | Biomet Microfixation, Inc. | 2011-05-18 | 78 | 1 |
| K091058 | ADKINS STRUT | Biomet Microfixation, Inc. | 2009-07-22 | 100 | 0 |
| K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | Biomet Microfixation, Inc. | 2008-05-09 | 24 | 0 |
| K071577 | BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER | Biomet Microfixation, Inc. | 2007-09-06 | 90 | 1 |
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