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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 11-378
Standard
ASTM F2502-17
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 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FDA recognition of ASTM F2502-11 [Rec# 11-270] will be superseded by recognition of ASTM F2502-17 [Rec# 11-378]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-270] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 11-270] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3040 Pin, Fixation, Smooth Class 2 HTY
§888.3040 Screw, Fixation, Bone Class 2 HWC
§888.3030 Plate, Fixation, Bone Class 2 HRS
FDA Technical Contacts
 Christopher Ferreira
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/
  301-796-9350
  christopher.ferreira@fda.hhs.gov
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@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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