FDA Product Code HRX: Arthroscope
FDA product code HRX covers arthroscopes used for direct visualization of joint interiors during arthroscopic surgery.
These rigid optical instruments are inserted through small portals into the joint to visualize cartilage, ligaments, and synovial tissue during diagnostic and therapeutic arthroscopic procedures. They are used in knee, shoulder, hip, ankle, and wrist arthroscopy.
HRX devices are Class II medical devices, regulated under 21 CFR 888.1100 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Intravu, Inc., Arthrex, Inc. and Lesspine Innovations.
FDA 510(k) Cleared Arthroscope Devices (Product Code HRX)
About Product Code HRX - Regulatory Context
510(k) Submission Activity
680 total 510(k) submissions under product code HRX since 1977, with 680 receiving FDA clearance (average review time: 132 days).
Submission volume has remained relatively stable over the observed period, with 13 submissions in the last 24 months.
FDA Review Time
Recent submissions under HRX have taken an average of 158 days to reach a decision - up from 131 days historically. Manufacturers should account for longer review timelines in current project planning.
HRX devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →