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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 11-327
ASTM  F543-17
Standard Specification and Test Methods for Metallic Medical Bone Screws
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:
1.2.1 Annex A1-Test Method for Determining the Torsional Properties of Metallic Bone Screws.
1.2.2 Annex A2-Test Method for Driving Torque of Medical Bone Screws.
1.2.3 Annex A3-Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.
1.2.4 Annex A4-Test Method for Determining the Self- Tapping Performance of Self-Tapping Medical Bone Screws.
1.2.5 Annex A5-Specifications for Type HA and Type HB Metallic Bone Screws.
1.2.6 Annex A6-Specifications for Type HC and Type HD Metallic Bone Screws.
1.2.7 Annex A7-Specifications for Metallic Bone Screw Drive Connections.
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3030 Plate, Fixation, Bone Class 2 HRS
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3040 Pin, Fixation, Threaded Class 2 JDW
Relevant FDA Guidance and/or Supportive Publications*
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff, issued December 2020.

Reviewers Guidance Checklist for Orthopedic External Fixation Devices Version #5, issued 2/21/97.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Christopher Ferreira
 Jonathan Peck
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.