PMA P000013S026

Device: Trident Acetabular System: Trident Alumina Inserts
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S026
Product code: MRA
Decision date: 2025-05-23
Classification: Orthopedic
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: approval for changes to the product labeling of the Trident Alumina Inserts that are part of the Trident Acetabular System (PMA #P000013).

Current openFDA PMA Record#

Device: Trident Acetabular System: Trident Alumina Inserts
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S026
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2025-05-23
Decision code: APPR
Date received: 2025-04-24
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for changes to the product labeling of the Trident Alumina Inserts that are part of the Trident Acetabular System (PMA #P000013).