PMA P000013S019

Device: Trident(R) Acetabular System
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S019
Product code: MRA
Decision date: 2022-03-01
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: Introduction of a process optimization for the sintering process with a new Hot Isostatic Pressure (HIP) equipment for the Trident Acetabular System.

Current openFDA PMA Record#

Device: Trident(R) Acetabular System
Applicant: Howmedica Osteonics Corp.
PMA number: P000013
Supplement: S019
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2022-03-01
Decision code: OK30
Date received: 2022-02-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduction of a process optimization for the sintering process with a new Hot Isostatic Pressure (HIP) equipment for the Trident Acetabular System.