Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions

29 March 2023 – the FDA published draft guidance on the premarket submissions for orthopedic non-spinal bone plates, screws, and washers. Submit comments by 29 May 2023.

This draft guidance document provides recommendations for premarket notification (510(k)) submissions for non-resorbable bone plate, screw, and washer devices. These devices are indicated for orthopedic bone fixation and exclude indications for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation.