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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 065 Date of Entry 12/22/2025 
FR Recognition Number 11-438
Standard
ASTM  F2502-24
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Scope/Abstract
1.1 This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as "absorbable") resins or resin composites.

1.2 This specification establishes a common terminology to describe the size and other physical characteristics of absorbable implants and performance definitions related to the performance of absorbable devices.

1.3 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of absorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed.

1.4 This specification may not be appropriate for all absorbable devices, especially those that possess limited hydrolytic susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application.
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.
Transition Period
FDA recognition of ASTM F2502-17 [Rec# 11-378] will be superseded by recognition of ASTM F2502-24 [Rec# 11-438]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-378] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 11-378] will not be accepted.
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 Pin, Fixation, Smooth Class 2 HTY
§888.3040 Screw, Fixation, Bone Class 2 HWC
Relevant FDA Guidance and/or Supportive Publications*
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 Contact
 Mahlet Zinah
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/
  240-402-2623
  Mahlet.Zinah@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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