NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES

K960279 · Zimmer, Inc. · JWH · Apr 26, 1996 · Orthopedic

Device Facts

• Record ID: K960279
• Device Name: NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities.

Device Story

NexGen Legacy PS and CCK femoral components and articular surfaces; total knee replacement implants. Designed to reduce pain and restore knee joint function/motion. Used in orthopedic surgery; implanted by surgeons. Fixation achieved via bone cement. Components replace damaged joint surfaces in patients with severe arthritis or deformity. Benefits include pain relief and improved mobility.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by literature studies on predicate devices demonstrating satisfactory clinical results.

Technological Characteristics

Metal/polymer semiconstrained cemented knee prosthesis. Components include femoral components and articular surfaces. Fixation via bone cement.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, pseudogout, or posttraumatic loss of joint configuration (including patellofemoral erosion, dysfunction, prior patellectomy, or moderate valgus/varus/flexion deformities).

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

• NexGen Posterior Stabilized
• Insall/Burstein II Posterior Stabilized
• NexGen Constrained Condylar Knee
• Insall/Burstein II Modular Knee System
• Insall/Burstein Constrained Condylar Knee

Submission Summary (Full Text)

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

K960279

# Summary of Safety and Effectiveness
NexGen® Complete Knee Solution Legacy Posterior Stabilized (PS) and
Constrained Condylar Knee (CCK) Femoral Components and Articular Surfaces

## Information is being submitted in accordance with the requirements of SMDA 1990

APR 26 1996

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

- Prepared by:
Ruth Ann Wood
Regulatory Affairs Associate

- Date:
January 18, 1996

- Trade Name:
NexGen Legacy PS (L-PS) and NexGen Legacy CCK (L-CCK)

- Classification Name:
Knee joint femorotibial metal/polymer semiconstrained cemented prosthesis

- Predicate Devices:
- The NexGen Legacy Posterior Stabilized Knee equals NexGen Posterior Stabilized and Insall/Burstein II Posterior Stabilized
- The NexGen Legacy Constrained Condylar Knee equals NexGen Constrained Condylar Knee, Insall/Burstein® II Modular Knee System, and Insall/Burstein® Constrained Condylar Knee

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A Bristol-Myers Squibb Company

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- Intended Use:

To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities.

- Comparison to Predicate Devices:

See attached chart.

- Clinical and Nonclinical Uses:

Current methods of implant fixation rely on the use of bone cement. Numerous studies reported in literature indicate satisfactory results have been obtained through use of devices to which substantial equivalence is claimed.

RA10501K.RP

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