FDA applicant
Icon Orthopaedic Concepts Dba Edge Orthopaedics
FDA records 1 decision for Icon Orthopaedic Concepts Dba Edge Orthopaedics (Boonton, NJ) in 2013: 1 510(k) clearance. All are in product code HWC (Screw, Fixation, Bone). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Icon Orthopaedic Concepts Dba Edge Orthopaedics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Icon Orthopaedic Concepts Dba Edge…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Icon”
FDA records each applicant name separately; these may or may not be the same firm.