Revision of F1378-18e1 Standard Specification for Shoulder Prostheses
Rationale
The subcommittee agreed to revise this standard. The 2018 version of the standard was not aligned with current technical and regulatory expectations for new shoulder arthroplasty implants. The revision primarily focused on updates to the performance requirements section. This section now includes general information for testing and performance requirements for wear testing of shoulder prostheses, range of motion of shoulder prosthesis, impingement and scapular notching, fatigue strength of stemmed humeral components, fretting corrosion of modular head/stem taper junctions, anatomic glenoid locking mechanism in shear, glenoid component loosening, humeral component loosening, humeral liner disassembly strength, and other modular connection statis and fatigue properties. In addition, figures, materials and manufacture, and references have been updated.
This is the 1st ballot for this standard. This standard will automatically be withdrawn if not approved on or before December 31, 2026.
Work Item Status
Date Initiated: 02-03-2026
Technical Contact: Derek Holyoak
Item: 000
Ballot:
Status: