Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Trauma (Aka Ebi, Lp) · 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) |
|---|---|---|---|---|---|
| K092528 | BIOMET FORERUNNER LOCKING PLATE SYSTEM | Biomet Trauma (Aka Ebi, Lp) | 2010-05-21 | 276 | 0 |
| K093983 | SMPLE PLATE AND SCREWS | Biomet Trauma (Aka Ebi, Lp) | 2010-03-19 | 85 | 0 |
| K093761 | OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING S | Biomet Trauma (Aka Ebi, Lp) | 2010-03-05 | 88 | 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