> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 2 Orthopedic Non-Spinal Bone Guidances Posted
- URL: https://www.fdaweb.com/2-orthopedic-non-spinal-bone-guidances-posted/
- Published: 2024-11-22T12:00:00.000Z
- Updated: 2026-09-14T14:47:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158246

FDA is publishing two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers. The first guidance, “[Orthopedic Non-Spinal Bone Plates, Screws, and Washers — Premarket Notification (510(k)) Submissions](https://www.fda.gov/media/166507/download?ref=fdaweb.com),” provides recommendations for submissions involving non-resorbable bone plate, screw, and washer devices. The devices are indicated for orthopedic bone fixation and exclude indications for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation, according to the agency.

The other guidance, “[Orthopedic Non-Spinal Metallic Bone Screws and Washers — Performance Criteria for Safety and Performance Based Pathway](https://www.fda.gov/media/130866/download?ref=fdaweb.com),” provides performance criteria for non-spinal metallic bone screws and associated washers in support of the agency’s Safety and Performance Based Pathway. Under the pathway, sponsors planning to submit a 510(k) for these devices will have the option to use the performance criteria proposed in the document to support substantial equivalence, rather than a direct comparison to a predicate device.