Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OQI · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
263 daysmedian FDA review time
370 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252451 | EPORE® XO cup system | Implantcast GmbH | 2026-04-24 | 263 | 0 |
| K192989 | Libertas E-XLPE Modular Liner | Maxx Orthopedics, Inc. | 2020-10-29 | 370 | 0 |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | 2018-06-12 | 266 | 0 |
| K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | Exactech, Inc. | 2018-03-12 | 112 | 3 |
| K111481 | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS | Corin USA | 2012-02-06 | 255 | 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