NexGen® LPS-Flex/LPS Mobile Bearing Knee System
Zimmer, Inc. · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing · Orthopedic
Open FDA's page for this record- PMA number
- P060037
- Supplement number
- S100
- Applicant
- Zimmer, Inc.
- Street 1
- P.O. Box 708
- City
- Warsaw
- State
- IN
- Zip
- 46581
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Trade name
- NexGen® LPS-Flex/LPS Mobile Bearing Knee System
- Product code
- NJL
- Advisory committee
- OR
- Advisory committee description
- Orthopedic
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-10-06
- Decision date
- 2026-10-16
- Decision code
- OK30
- Ao statement
- expansion of ISO Class 7 packaging cleanroom space and corridor at the Zimmer Inc Warsaw West facility
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 1526534, 1834331, 3010132111, 3008868758, 1822565, 8043792, 9616671, 3006356043, 3010173425, 2528981, 8010379, 1724955, 3015207155, 1219655, 3004464325, 1038671, 3000236920, 3008812251, 3007539489, 3009116370, 3004748528, 3015516266, 3009882462, 1218882, 3013055499, 1827096, 2245304, 1220477, 1818910, 3002807310, 3011683674, 1450662, 1721676, 1828464, 3015542154, 3007963827, 3005061536
- FEI number
- 1526534, 3010132111, 3008868758, 3006356043, 3002807036, 2528981, 3015207155, 3003142829, 1219655, 1038671, 3004464325, 3002808269, 1000086912, 3007539489, 3009116370, 3002854251, 1000199976, 3004748528, 3015516266, 3009882462, 1218882, 3013055499, 1827096, 2245304, 1000306340, 1220477, 1818910, 3002808293, 3002807310, 1000220733, 3011683674, 1450662, 1721676, 1828464, 3015542154, 3007963827, 3005061536