Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intelligent Orthopaedics, Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111001 | STERILE STORM (R) OPERATING KIT | Intelligent Orthopaedics, Ltd. | 2011-05-17 | 36 | 0 |
| K070724 | IOS EXTERNAL FIXATOR, MODEL 2-0-0 | Intelligent Orthopaedics, Ltd. | 2007-05-16 | 62 | 0 |
| K061607 | STORM OPERATING KIT, MODEL 1-10-0 | Intelligent Orthopaedics, Ltd. | 2006-07-18 | 39 | 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