510(k) Report

FDA applicant

Responsive Orthopedics, LLC

Columbia City, IN2 decisions2015–201712 recalls

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, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Responsive Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015: 12017: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

4in 2017

2016: 82017: 4
2015high 8 (2016) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Responsive Orthopedics, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Responsive”

FDA records each applicant name separately; these may or may not be the same firm.