PI 99: Standard Specification for Acetabular Prostheses
ASTM F2091-15 has been withdrawn in 2023. Standard specifications for acetabular prostheses can now be found in ISO 21535. The primary reason for the withdrawal is the transition to the more current international standard ISO 21535, which covers “Non-active surgical implants — Joint replacement implants.”
This shift aligns with the FDA’s recognition process, where ASTM F2091-15 and ASTM F2068-15 are being superseded by ISO 21535, with a transition period ending on December 21, 2025.
For manufacturers and stakeholders, it’s crucial to note that after December 21, 2025, declarations of conformity to ASTM F2091-15 will no longer be accepted by the FDA. Therefore, aligning with ISO 21535 is essential for compliance and market acceptance.
EndoLab has transferred ASTM F2091 into an accredited internal standard to keep this standard available if needed.
