FDA applicant
Nextremity Solutions, Inc.
FDA records 20 decisions for Nextremity Solutions, Inc. (Warsaw, IN) from 2011 to 2022: 20 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 47 predicates, 18 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “Nextremity Solutions, LLC”, “Nextremity Solutions”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nextremity Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2022
2026 so far, outlined.
Recalls per year
7in 2022
Class I Class II/III not classified
Planning a device like Nextremity Solutions, 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