Federal Register #2026-11302

FDA Classifies Absorbable Metallic Bone Fixation Fastener as Class II Medical Device

This FDA final rule establishes a new device classification for absorbable metallic bone fixation fasteners: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Product/Device Details: - Absorbable metallic bone fixation fastener (e.g., bone screw, pin, Kirschner wire) - Made from absorbable metal or metal alloys - Intended for rigid bone fixation in osteosynthesis, fully absorbing after bone healing - Requirements and Controls: - Clinical data and non-clinical performance testing required - Biocompatibility, sterility, and shelf-life validation - Detailed labeling: material composition, absorption byproducts, technical parameters, expiration date, revision surgery instructions, time to complete absorption, and clinical data summary - No specific OEMs or vendors are named in this rule - Classification as Class II with special controls aims to ensure safety, effectiveness, and facilitate access to innovative devices

Description

The Food and Drug Administration (FDA) is classifying the absorbable metallic bone fixation fastener into class II with special controls. This device is an implant such as a bone screw, pin, or Kirschner wire composed of absorbable metal or metal alloys intended to provide rigid bone fixation suitable for osteosynthesis and designed to fully absorb after osteosynthesis is achieved. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The special controls include requirements for clinical data, non-clinical performance testing, biocompatibility, sterility, shelf-life, and detailed labeling.

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