Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MAY · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123604 | ABG III MONOLITHIC HIP STEM | Howmedica Osteonics Corp. | 2013-08-16 | 268 | 1 |
| K110807 | ABG II MONOLITHIC HIP STEM | Stryker Corp. | 2011-05-25 | 63 | 0 |
| K090103 | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAX | Biomet, Inc. | 2009-02-11 | 27 | 0 |
| K051844 | EQUATOR PLUS ACETABULAR CUP SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2005-10-07 | 92 | 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