FDA applicant
Onkos Surgical
FDA records 11 decisions for Onkos Surgical (Parsippany, NJ) from 2016 to 2026: 10 510(k) clearances and 1 De Novo grant. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and QZZ (Limb And Joint Salvage Device With Coating For…). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 162 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 10 of them its own earlier devices. 16 recalls are linked to its devices.
FDA’s records also spell it “Onkos Surgical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Onkos Surgical’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Onkos Surgical’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