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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 11-334
ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
Scope/Abstract
1.1 This test method covers a method for determining the static shear disassembly force of modular anatomic glenoid components used in anatomic total shoulder arthroplasty prostheses.

1.2 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitro comparison of modular anatomic glenoid component designs and the strength of the retention mechanism between the articular insert and glenoid backing under the stated test conditions.

1.3 This test method covers modular glenoid components comprised of a separate articular insert and backing. The insert and backing can be fabricated from any combination of the following materials: metal alloys, polymeric materials, composite materials.

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FDA recognition of ASTM F1829-16 [Rec# 11-315] will be superseded by recognition of ASTM F1829-17 [Rec# 11-334]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-315] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 11-315] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3640 Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented Class 3 KWR
§888.3650 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 KWT
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Class 2 PAO
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 KWS
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§888.3680 Metallic Cemented Glenoid Hemi-Shoulder Prosthesis Class 3 KYM
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Noncontrained or Semi-Constrained Porous-Coated Uncemented Prosthesis, Issued October 2000
FDA Technical Contact
 John Goode
  FDA/OMPT/CDRH/ODE/DOD/JFDB2/
  301-796-6407
  john.goode@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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