Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zimmer Biomet — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
255 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251834 | Persona Partial Knee | Zimmer Biomet | 2025-08-15 | 60 | 0 |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Line | Zimmer Biomet | 2025-07-31 | 255 | 0 |
| K251620 | A.L.P.S. Proximal Humerus Plating System | Zimmer Biomet | 2025-07-25 | 59 | 0 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 | 30 | 0 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 | 63 | 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