Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kico Knee Innovation Company Pty Limited · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025-03-21 | 88 | 1 |
| K223927 | 360CAS | Kico Knee Innovation Company Pty Limited | 2023-01-27 | 28 | 0 |
| K213380 | 360CAS | Kico Knee Innovation Company Pty Limited | 2022-01-11 | 90 | 0 |
| K163405 | 360KS Implant Positioning System | Kico Knee Innovation Company Pty Limited | 2017-03-21 | 106 | 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