Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Depuy(Ireland) · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
260 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212683 | GLOBAL ICON Stemless Shoulder System | Depuy(Ireland) | 2022-01-19 | 148 | 0 |
| K192855 | DELTA XTEND(TM) Reverse Shoulder System | Depuy(Ireland) | 2020-02-24 | 143 | 0 |
| K190344 | DePuy Corail AMT Hip Prosthesis | Depuy(Ireland) | 2019-11-01 | 260 | 0 |
| K191779 | Attune Revision LPS Inserts | Depuy(Ireland) | 2019-10-08 | 98 | 4 |
| K192448 | Delta Xtend Revers Shoulder System | Depuy(Ireland) | 2019-10-04 | 28 | 0 |
| K183077 | Delta Xtend Reverse Shoulder System | Depuy(Ireland) | 2019-05-17 | 193 | 0 |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Depuy(Ireland) | 2017-06-15 | 90 | 0 |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy(Ireland) | 2016-07-19 | 109 | 0 |
| K160700 | ATTUNE Revision Knee System | Depuy(Ireland) | 2016-06-10 | 88 | 2 |
| K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMP | Depuy(Ireland) | 2015-02-13 | 312 | 10 |
| K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | Depuy(Ireland) | 2014-04-03 | 107 | 1 |
| K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | Depuy(Ireland) | 2010-12-15 | 153 | 0 |
| K102080 | DEPUY RECLAIM REVISION HIP SYSTEM | Depuy(Ireland) | 2010-11-23 | 120 | 3 |
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