FDA applicant
Responsive Orthopedics, LLC
FDA records 2 decisions for Responsive Orthopedics, LLC (Columbia City, IN) from 2015 to 2017: 2 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 15 predicates, 0 of them its own earlier devices. 12 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Responsive Orthopedics, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
4in 2017
Class I Class II/III not classified
Planning a device like Responsive Orthopedics, 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.