NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE

K951185 · Zimmer, Inc. · JWH · Mar 15, 1996 · Orthopedic

Device Facts

• Record ID: K951185
• Device Name: NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to reduce or relieve pain and restore function and motion to the knee joint.

Device Story

NexGen Complete Knee Solution 9 mm tibial articular surfaces; molded ultra-high molecular-weight polyethylene (UHMWPE) components; snapped into NexGen tibial plates; curved in frontal and sagittal planes; posterior stabilized version features increased anterior sagittal curvature; used by orthopedic surgeons in clinical settings for total knee arthroplasty; restores joint function and relieves pain.

Clinical Evidence

No clinical data provided for subject device; reliance on literature studies for predicate devices indicating satisfactory clinical results.

Technological Characteristics

Material: Ultra-high molecular-weight polyethylene (UHMWPE). Form factor: 9 mm tibial articular surface. Design: Curved in frontal and sagittal planes; snap-fit attachment to tibial plates.

Indications for Use

Indicated for patients requiring knee joint replacement to reduce pain and restore function and motion.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• MG II® Total Knee System
• Insall/Burstein® II Modular Knee System

Submission Summary (Full Text)

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Zimmer

MAR 15 1996

PO Box 708
Warsaw, IN 46581-0708
219 267-6131

# Summary of Safety and Effectiveness
## NexGen™ Complete Knee Solution, 9 mm Tibial Articular Surfaces

This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.

- Submitted by:
Zimmer, Inc.
345 East Main Street
P.O. Box 708
Warsaw, Indiana 46581-0708

- Prepared by:
Ruth Ann Wood
Regulatory Affairs Associate

- Date:
March 15, 1995

- Trade Name:
NexGen™ Total Knee Solution
9 mm Tibial Articular Surface

- Classification Name:
Knee joint patellofemorotibial polyethylene/metal/polyethylene semiconstrained cemented prosthesis 21 CFR 888.3560.

- Identification of the Predicate Device:
MG II® Total Knee System and Insall/Burstein® II Modular Knee System

- Summary Description:
The NexGen™ Complete Knee Solution, 9 mm articular surfaces are made of molded ultra-high molecular-weight polyethylene (UHMWPE). As with the MG II Knee, each

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articular surface is snapped into one of a series of the NexGen Knee tibial plates. The components are curved in both the frontal and sagittal planes. The posterior stabilized version having slightly more curvature in the anterior portion of the sagittal plane.

- Summary of Intended Uses:
The device is intended to reduce or relieve pain and restore function and motion to the knee joint.

- Comparison to the Predicate Device:
The 9 mm tibial articular surfaces have the same basic geometric shape, intended use and material as the predicate device.

- Clinical and Nonclinical Data:
Numerous studies reported in the literature for the predicate devices indicate that satisfactory results have been obtained through the use of 9 mm tibial articular surfaces.

RA03501K.RP

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