Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142135 | REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | 2014-08-28 | 24 | 5 |
| K140876 | VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCRE | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | 2014-07-22 | 106 | 15 |
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