FDA applicant
Ortho Solutions UK, Ltd.
FDA records 5 decisions for Ortho Solutions UK, Ltd. (Maldon, GB) from 2017 to 2025: 5 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and JDR (Staple, Fixation, Bone). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Ortho Solutions UK Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ortho Solutions UK, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Ortho Solutions UK, 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) ReportOther applicant names beginning “Ortho”
FDA records each applicant name separately; these may or may not be the same firm.