PMA P070026S048
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S048
- Product code
- MRA
- Decision date
- 2017-07-13
- 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
- Two changes to the SUMMIT and TRI-LOCK BPS hip stems: automation of the turn taper and laser etch operations, and an increase in degrease process capacity from 2 units/cycle to 5 units/cycle. A third change is proposed to the TRI-LOCK BPS hip stems, which will be to implement a new protective guard to be used during the polishing process.
Current openFDA PMA Record#
- Device
- Ceramax Ceramic Total Hip System
- Applicant
- DePuy Orthopaedics, Inc.
- PMA number
- P070026
- Supplement
- S048
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2017-07-13
- Decision code
- OK30
- Date received
- 2017-06-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Two changes to the SUMMIT and TRI-LOCK BPS hip stems: automation of the turn taper and laser etch operations, and an increase in degrease process capacity from 2 units/cycle to 5 units/cycle. A third change is proposed to the TRI-LOCK BPS hip stems, which will be to implement a new protective guard to be used during the polishing process.