Nexgen Lps-Flex Mobile and Lps-Mobile Bearing Knee System

FDA premarket approval P060037 · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

PMA numberP060037

Approval

Applicant
Zimmer, Inc.
Received
December 18, 2006
Decision date
December 10, 2007 (APPR)
Supplements
96, latest July 20, 2026
Product code
NJL – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Official FDA PMA record

Approval order statement

APPROVAL FOR THE ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES. THESE DEVICES ARE INDICATED FOR PATIENTS WITH SEVERE KNEE PAIN AND DISABILITY DUE TO OSTEOARTHRITIS; PRIMARY AND SECONDARY TRAUMATIC ARTHRITIS; AVASCULAR NECROSIS OF THE FEMORAL CONDYLE; OR MODERATE VALGUS, VARUS, OR FLEXION DEFORMITIES (I.E., VALGUS/VARUS DEFORMITY OF <=15 DEGREES, FIXED FLEXION DEFORMITY OF <=10 DEGREES). THIS DEVICE IS INTENDED FOR CEMENTED USE ONLY.