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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 11-360
ASTM F1378-18e1 Standard Specification for Shoulder Prostheses
Scope/Abstract
1.1 This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components.

1.2 Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification.

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FDA recognition of ASTM F1378-17 [Rec# 11-328] will be superseded by recognition of ASTM F1378-18e1 [Rec# 11-360]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-328] until December 27, 2020. After this transition period, declarations of conformity to [Rec# 11-328] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented Class 3 MJT
Regulation Number Device Name Device Class Product Code
§888.3640 Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented Class 3 KWR
Regulation Number Device Name Device Class Product Code
§888.3650 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 KWT
Regulation Number Device Name Device Class Product Code
§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
Regulation Number Device Name Device Class Product Code
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
Regulation Number Device Name Device Class Product Code
§888.3680 Metallic Cemented Glenoid Hemi-Shoulder Prosthesis Class 3 KYM
Regulation Number Device Name Device Class Product Code
§888.3690 Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class 2 HSD
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis, Issued October 2000.
FDA Technical Contact
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  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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