FDA applicant
Responsive Arthroscopy, LLC
FDA records 13 decisions for Responsive Arthroscopy, LLC (Minneapolis, MN) from 2018 to 2026: 13 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 75 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Responsive Arthroscopy, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Responsive Arthroscopy, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Responsive Arthroscopy, 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 “Responsive”
FDA records each applicant name separately; these may or may not be the same firm.