NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

FDA premarket approval P060037 · decided 2007-12-10

Approval details

PMA number: P060037
Trade name: 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: 2006-12-18
Decision date: 2007-12-10
Days to decision: 357 days
Decision code: APPR
Product code: NJL
Advisory committee: Orthopedic
Expedited review: No
Location: Warsaw, IN
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.

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