Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dj Orthopedics, LLC · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
196 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021740 | TOTAL KNEE CEMENTED, SEMI-CONSTRAINED | Dj Orthopedics, LLC | 2002-09-23 | 118 | 0 |
| K011354 | HIGH TIBIAL OSTEOTOMY PLATING SYSTEM | Dj Orthopedics, LLC | 2001-07-31 | 89 | 0 |
| K010594 | DJ ORTHOPEDICS POST SCREW | Dj Orthopedics, LLC | 2001-05-29 | 90 | 0 |
| K010595 | DJ ORTHOPEDICS INTERFERENCE SCREW | Dj Orthopedics, LLC | 2001-05-08 | 69 | 0 |
| K002829 | DJ ORTHOPEDICS FEMORAL ANCHOR | Dj Orthopedics, LLC | 2001-03-26 | 196 | 0 |
| K003960 | DJ ORTHOPEDICS TIBIAL ANCHOR | Dj Orthopedics, LLC | 2001-03-21 | 90 | 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