Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthocor Medical · 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) |
|---|---|---|---|---|---|
| K121702 | ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE | Orthocor Medical | 2013-05-06 | 332 | 0 |
| K092044 | ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE | Orthocor Medical | 2009-12-18 | 165 | 0 |
| K091996 | ORTHOCOR KNEE SYSTEM BASIC | Orthocor Medical | 2009-12-15 | 166 | 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