NEXGEN COMPLETE KNEE SOLUTION
FDA premarket approval P060037/S005 · decided 2009-03-26
Approval details
- PMA number
- P060037
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEXGEN COMPLETE KNEE SOLUTION
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Zimmer, Inc.
- Date received
- 2008-09-29
- Decision date
- 2009-03-26
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT,RESULTING IN THE NEXGEN MINIMALLY INVASIVE SOLUTIONS (MIS) LPS-MOBILE TIBIAL COMPONENT.CHANGES MADE TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT INCLUDE SHORTENING THETIBIAL BASEPLATE STEM AND ADDING BROAD PROXIMAL FINS, CHANGING THE OUTER PROFILE RADIUS OF THEBASEPLATE EDGE FROM A VARIABLE RADIUS TO A CONSTANT RADIUS, AND ADDING AN ADDITIONAL SIZE (4-PLUS)TO THE CURRENT RANGE OF SIZES (1 - 8).
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510(k) clearances by this applicant
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|---|---|---|
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
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| Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189) | Zimmer, Inc. | 2026-03-09 |
| G7® Revision Acetabular System (K252623) | Zimmer, Inc. | 2026-02-04 |