ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
FDA premarket approval P060037/S007 · decided 2009-01-23
Approval details
- PMA number
- P060037
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2008-11-25
- Decision date
- 2009-01-23
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A MODIFICATION TO THE APPROVED SURGICAL TECHNIQUE TO ADD AN OPTIONAL TECHNIQUE FOR MAKING THE FEMORAL BONE CUTS FOR THE LPS-FLEX MOBILE FEMORAL COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMS AND IS INDICATED FOR PATIENTS WITH SEVERE KNEE PAIN AND DISABILITY DUE TO OSTEOARTHRITIS, PRIMARY AND SECONDARY TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS OF THE FEMORAL CONDYLE, AND MODERATE VALGUS, VARUS,
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