FDA applicant
Crossroads Extremity Systems, LLC
FDA records 16 decisions for Crossroads Extremity Systems, LLC (Memphis, TN) from 2015 to 2026: 16 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 10 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Crossroads Extremity Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Crossroads Extremity Systems, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Crossroads Extremity Systems, LLC’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 “Crossroads”
FDA records each applicant name separately; these may or may not be the same firm.