PMA P010014S080
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S080
- Product code
- NRA
- Decision date
- 2018-07-27
- Classification
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Upgrade the cleaning process for the Oxford Partial Knee metal components. The new validated cleaning process consists of an in-process cleaning operation through the Elma 3-Stage Cleaning Process, a final cleaning operation through the Elma 5-Stage Final Cleaning Process and a biological upgrade in nitric acid.
Current openFDA PMA Record#
- Device
- Oxford Partial Knee System
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S080
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2018-07-27
- Decision code
- OK30
- Date received
- 2018-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrade the cleaning process for the Oxford Partial Knee metal components. The new validated cleaning process consists of an in-process cleaning operation through the Elma 3-Stage Cleaning Process, a final cleaning operation through the Elma 5-Stage Final Cleaning Process and a biological upgrade in nitric acid.