FDA applicant
OSSIO, Ltd.
FDA records 20 decisions for OSSIO, Ltd. (Caesarea, IL) from 2019 to 2026: 20 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HTY (Pin, Fixation, Smooth). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 42 predicates, 27 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided OSSIO, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like OSSIO, Ltd.’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