PMA P000013S010
- Device
- TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S010
- Product code
- MRA
- Decision date
- 2012-01-18
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE TRITANIUM PSF ACETABULAR SHELLS (SOLID-BACKED AND CLUSTER SCREW-HOLE DESIGNS) AS COMPATIBLE COMPONENTS WITH THE TRIDENT CERAMIC INSERTS, AS WELL AS MODIFICATIONS TO THE TOLERANCES AND SURFACE ROUGHNESS VALUES OF THE TAPER REGION OF ALL COMPATIBLE TRIDENT AND TRITANIUM ACETABULAR SHELLS. IN ADDITION, LABELING CHANGES WERE MADE TO ADDRESS THE COMPATIBILITY WITH THE NEW COMPONENTS.
Current openFDA PMA Record#
- Device
- TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S010
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2012-01-18
- Decision code
- APPR
- Date received
- 2011-10-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE TRITANIUM PSF ACETABULAR SHELLS (SOLID-BACKED AND CLUSTER SCREW-HOLE DESIGNS) AS COMPATIBLE COMPONENTS WITH THE TRIDENT CERAMIC INSERTS, AS WELL AS MODIFICATIONS TO THE TOLERANCES AND SURFACE ROUGHNESS VALUES OF THE TAPER REGION OF ALL COMPATIBLE TRIDENT AND TRITANIUM ACETABULAR SHELLS. IN ADDITION, LABELING CHANGES WERE MADE TO ADDRESS THE COMPATIBILITY WITH THE NEW COMPONENTS.