FDA 510(k) Orthopedic Devices

FDA 510(k) Orthopedic Devices - Regulatory Overview

FDA 510(k) orthopedic devices include implants, instruments and systems used in musculoskeletal surgery and rehabilitation. The FDA review panel code is OR.

Key categories:

• Joint replacement implants - hip, knee, shoulder and ankle prostheses
• Bone fixation systems - plates, screws, nails and external fixators
• Spinal implants - cages, rods, pedicle screws and disc replacements
• Surgical navigation - image-guided and robotic-assisted orthopedic surgery
• Bone grafts and substitutes - synthetic and allograft bone repair materials

With 17,685 submissions, this is one of the largest 510(k) categories. Data sourced from FDA 510(k) public files. Updated monthly.