Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wiltrom Corporation Limited — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
192 daysmedian FDA review time
533 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202894 | Wiltrom Spinal Fixation System | Wiltrom Corporation Limited | 2020-10-23 | 25 | 0 |
| K180758 | Osteocera Resorbable Bone Substitute | Wiltrom Corporation Limited | 2018-10-24 | 216 | 0 |
| K172237 | Bicera Resorbable Bone Substitute | Wiltrom Corporation Limited | 2018-02-02 | 192 | 0 |
| K172548 | Wiltrom Spinal Fixation System | Wiltrom Corporation Limited | 2018-01-12 | 142 | 0 |
| K110949 | BICERA (TM) RESORBABLE BONE SUBSTITUTE | Wiltrom Corporation Limited | 2012-09-18 | 533 | 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