Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Orthopedics — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026-04-15 | 258 | 0 |
| K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics | 2025-02-19 | 75 | 0 |
| K223631 | Comprehensive Segmental Revision System(SRS) | Biomet Orthopedics | 2023-07-12 | 219 | 0 |
| K200196 | Taperloc® Complete Hip Stems | Biomet Orthopedics | 2020-12-08 | 316 | 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