FDA applicant
Innovative Surgical Designs, Inc.
FDA records 9 decisions for Innovative Surgical Designs, Inc. (Bloomington, IN) from 2013 to 2022: 9 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Since 2016 its 510(k)s took a median of 61 days from receipt to decision, against 69 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Innovative Surgical Designs”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Innovative Surgical Designs, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Innovative Surgical Designs, 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