Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Basic Information
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Trade Name
- NexGen® LPS-Flex LPS-Mobile Bearing Knee
- PMA Number
- P060037
- Supplement Number
- S091
- Device Class
- FDA Class 3
- Product Code
- NJL
- Generic Name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- July 5, 2024
- Date Received
- June 27, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
two changes to the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components manufactured at the Zimmer Orthopedics Manufacturing Limited, Shannon, Ireland facility. Change One includes changing the order of the manufacturing process flow steps, to introduce additional in-process cleaning step, and to introduce anewer model of the laser etch equipment and fixture for the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components. Change Two includes the introduction of Haas Multigrind Grind equipment and Intec Robotic Polisher equipment for the Grind and Polish operations of the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NJL | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | FDA class 3 | Unknown |