Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KWM — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
578 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880156 | VOLZ TOTAL WRIST PROSTHESIS | Biomet, Inc. | 1988-02-17 | 35 | 0 |
| K872502 | M.W.P. WRIST PROSTHESIS | Protek, Inc. | 1987-07-23 | 29 | 0 |
| K803031 | LAURE WRIST IMPLANT | Laure Prosthetics, Inc. | 1982-06-29 | 578 | 0 |
| K800602 | TALEISNIK TOTAL WRIST PROSTHESIS | Dow Corning Wright | 1980-08-27 | 163 | 0 |
| K801157 | WEBER-MAYO WRIST | Depuy, Inc. | 1980-08-04 | 82 | 0 |
| K790774 | LODA WRIST PROSTHESIS | Depuy, Inc. | 1979-08-03 | 105 | 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