PMA P000013

Device: Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S020
Product code: MRA
Decision date: 2025-09-17
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: the use of alternative sources for some of the ingredients which are part of the composition of the adhesive coating, TPT-0260, in the Tyvek packaging for the Osteonics ABC/Trident System / Trident Alumina Insert

Current openFDA PMA Record#

Device: Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S027
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-09-17
Decision code: OK30
Date received: 2025-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the use of alternative sources for some of the ingredients which are part of the composition of the adhesive coating, TPT-0260, in the Tyvek packaging for the Osteonics ABC/Trident System / Trident Alumina Insert