Responsive Orthopedics Total Hip Arthroplasty System— 510(k) K163585

Substantially Equivalent

Responsive Orthopedics, LLC

FDA 510(k) clearance K163585 for Responsive Orthopedics Total Hip Arthroplasty System, Substantially Equivalent on 2017-06-02. Applicant: Responsive Orthopedics, LLC.

Clearance details

Applicant: Responsive Orthopedics, LLC
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2016-12-20
Decision date: 2017-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia City, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.