FDA applicant
Stryker Trauma AG
FDA records 32 decisions for Stryker Trauma AG (Mahwah, NJ) from 2013 to 2020: 32 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 82 predicates, 15 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Stryker Trauma GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stryker Trauma AG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
2in 2021
Class I Class II/III not classified
Planning a device like Stryker Trauma AG’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 “Stryker”
FDA records each applicant name separately; these may or may not be the same firm.