Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet UK, Ltd. · 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) |
|---|---|---|---|---|---|
| K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic He | Biomet UK, Ltd. | 2020-07-29 | 110 | 0 |
| K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Head | Biomet UK, Ltd. | 2020-02-27 | 154 | 0 |
| K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARI | Biomet UK, Ltd. | 2014-03-28 | 95 | 3 |
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