Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KWN — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
160 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014-12-23 | 160 | 0 |
| K080997 | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | 2008-06-17 | 70 | 0 |
| K050028 | MAESTRO CARPAL HEMIARTHROPLASTY | Biomet Manufacturing, Inc. | 2005-03-25 | 78 | 0 |
| K864491 | SWANSON TITANIUM CARPAL LUNATE IMPLANT | Dow Corning Wright | 1987-04-15 | 153 | 0 |
| K790793 | AMC R METACARPAL COMPONENT | Howmedica Corp. | 1979-06-22 | 59 | 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