PMA P000013S018

Device: Trident Ceramic System
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S018
Product code: MRA
Decision date: 2021-03-05
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Approval for a change in packaging of the Trident Alumina inserts which are part of the Trident Ceramic System. The foam raw material used to manufacture the foam packaging components will change from Opflex Microcell L1900/MC1900 to Vizion 2.0, and the foam packaging component tolerances listed on the foam packaging component drawings will be updated to +/- 0.120 inches to align the drawings with the manufacturing process currently used by the foam packaging component supplier.

Current openFDA PMA Record#

Device: Trident Ceramic System
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S018
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2021-03-05
Decision code: APPR
Date received: 2021-01-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in packaging of the Trident Alumina inserts which are part of the Trident Ceramic System. The foam raw material used to manufacture the foam packaging components will change from Opflex Microcell L1900/MC1900 to Vizion 2.0, and the foam packaging component tolerances listed on the foam packaging component drawings will be updated to +/- 0.120 inches to align the drawings with the manufacturing process currently used by the foam packaging component supplier.