FDA 510(k) Orthopedic Devices

About Orthopedic Devices

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.