Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitek Worldwide — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
211 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032717 | BIOCRYL RAPIDE INTERFERENCE SCREW | Mitek Worldwide | 2004-03-31 | 211 | 0 |
| K032167 | BIO-INTRAFIX TIBIAL SCREW AND SHEATH | Mitek Worldwide | 2003-10-15 | 91 | 0 |
| K032078 | MITEK MICRO QUICKANCHOR | Mitek Worldwide | 2003-08-25 | 49 | 0 |
| K030995 | MINILOK QUICKANCHOR PLUS | Mitek Worldwide | 2003-06-26 | 87 | 0 |
| K031519 | CUFFLOK ANCHOR | Mitek Worldwide | 2003-06-06 | 22 | 0 |
| K031406 | EXOJET TISSUE MANAGEMENT SYSTEM | Mitek Worldwide | 2003-05-30 | 25 | 0 |
| K024115 | MICROFIX QUICKANCHOR PLUS | Mitek Worldwide | 2003-03-13 | 90 | 0 |
| K023388 | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM | Mitek Worldwide | 2002-12-27 | 79 | 0 |
| K021953 | MITEK PDS/PGA STAPLE | Mitek Worldwide | 2002-12-20 | 190 | 0 |
| K021883 | BIOFASTIN RC THREADED SUTURE ANCHOR | Mitek Worldwide | 2002-07-01 | 24 | 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