FDA applicant
Orthocon, Inc.
FDA records 40 decisions for Orthocon, Inc. (Irvington, NY) from 2005 to 2026: 40 510(k) clearances. Most are in product codes MTJ (Wax, Bone) and GXP (Methyl Methacrylate For Cranioplasty). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 75 predicates, 46 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Orthocon, LLC”, “Orthocon”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Orthocon, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orthocon, Inc.’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) Report