Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OIY — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
406 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252887 | DePuy ATTUNE™ Knee System | DePuy Orthopaedics, Inc. | 2026-05-22 | 254 | 0 |
| K242665 | DePuy ATTUNE™ Total Knee System | Depuy Orthopedics, Inc. | 2024-11-01 | 58 | 0 |
| K201347 | DePuy ATTUNE™ Total Knee System | DePuy Orthopaedics, Inc. | 2020-06-18 | 28 | 0 |
| K120038 | A200 KNEE SYSTEM | Renovis Surgical Technologies, LLC | 2013-02-14 | 406 | 0 |
| K121727 | MOVATION KNEE SYSTEM | Encore Medical L.P. | 2012-08-15 | 64 | 0 |
| K113756 | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINK | Encore Medical L.P. | 2012-03-14 | 84 | 1 |
| K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | DePuy Orthopaedics, Inc. | 2011-08-30 | 99 | 1 |
| K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM | DePuy Orthopaedics, Inc. | 2011-03-15 | 82 | 0 |
| K103223 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS | Encore Medical L.P. | 2010-12-21 | 50 | 0 |
| K101433 | DEPUY ATTUNE KNEE SYSTEM | DePuy Orthopaedics, Inc. | 2010-12-10 | 203 | 0 |
| K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 3 | Encore Medical L.P. | 2010-09-28 | 454 | 2 |
| K100048 | E1 ANTIOXIDANT INFUSED TECHNOLOGY | Biomet Manufacturing Corp | 2010-03-09 | 60 | 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