FDA applicant
Mako Surgical Corp.
FDA records 42 decisions for Mako Surgical Corp. (Fort Lauderdale, FL) from 2005 to 2026: 42 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and HSX (Prosthesis, Knee, Femorotibial…). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 96 predicates, 43 of them its own earlier devices. 39 recalls are linked to its devices.
FDA’s records also spell it “Mako Surgical Corporation”, “Mako Surgical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mako Surgical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Mako Surgical Corp.’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