ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE

K122529 · Zimmer, Inc. · HSX · Nov 16, 2012 · Orthopedic

Device Facts

• Record ID: K122529
• Device Name: ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
• Applicant: Zimmer, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Nov 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer Unicompartmental Knee System (ZUK) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device. The Zimmer Unicompartmental Knee System is indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. These devices are indicated for cemented use only. The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Device Story

Zimmer Unicompartmental Knee System (ZUK) replaces single knee compartment; unconstrained in anteroposterior/mediolateral directions; allows internal/external rotation limited by patient soft tissues. Device utilizes Vivacit-E Vitamin E highly crosslinked polyethylene (UHMWPE) articular surfaces. Intended for surgical implantation in patients with osteoarthritis, traumatic arthritis, or prior fracture/deformity. Surgeon performs cemented fixation. Vivacit-E material provides delamination resistance and reduced wear compared to conventional polyethylene. Device benefits include improved wear characteristics and durability for patients undergoing unicompartmental knee arthroplasty.

Clinical Evidence

No clinical data provided. Bench testing only: wear performance, delamination resistance, fatigue strength of locking mechanism, posterior edge crush fatigue, and human factors assembly force testing performed per ISO-14243.

Technological Characteristics

Unicompartmental knee prosthesis; metal/polymer construction. Articular surface utilizes Vivacit-E Vitamin E infused highly crosslinked UHMWPE. Cemented fixation. Mechanical design allows unconstrained rotation/translation. Bench testing conducted per ISO-14243.

Indications for Use

Indicated for patients with painful/disabling knee joints due to osteoarthritis or traumatic arthritis, previous tibial condyle/plateau fractures with loss of anatomy/function, varus/valgus deformities, or requiring revision of previous arthroplasty. Indicated for cemented use only; load-bearing ROM ≤ 155 degrees.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Zimmer Unicompartmental Knee System (K033363)
• Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (K120370)
• EITM Antioxidant Infused Technology (K100048)

Submission Summary (Full Text)

{0}------------------------------------------------

K122529 ('/3)

Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a stylized font.

NOV 1 6 2012

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

# Summary of Safety and Effectiveness

Sponsor:

Contact Person:

Date:

Trade Name:

Product Code / Device:

Regulation Number / Description:

Predicate Device:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Mark D. Warner Senior Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone]

August 17, 2012

Zimmer® Unicompartmental Knee System Vivacit-E® Articular Surface

HSX - Prosthesis, knee, femorotibial, nonconstrained, cemented, metal/polymer

OIY - Prosthesis, knee, patellofemorotibial, semiconstrained, cemented, polymer + additive / metal / polymer + additive

21 CFR § 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis

21 CFR § 888.3560 - Knee joint, patellofemorotibial, polymer / metal / polymer, semi-constrained, cemented prosthesis

Zimmer Unicompartmental Knee System, manufactured by Zimmer, Inc. (K033363, cleared January 6, 2003)

Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, manufactured by Zimmer, Inc. (K120370, cleared June 4, 2012)

{1}------------------------------------------------

K122S29(²/₃)

EITM Antioxidant Infused Technology, Manufactured by Biomet Manufacturing Corp. (K 100048, cleared March 9, 2010)

The Zimmer Unicompartmental Knee System (ZUK) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows · unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.

The Zimmer Unicompartmental Knee System is indicated for patients with:

- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.

These devices are indicated for cemented use only.

The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The proposed Zimmer Unicompartmental Knee System components are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.

Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.

Non-Clinical Performance and Conclusions:

Vivacit-E material characteristics for the Zimmer Unicompartmental Knee System (ZUK) are identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370). In contrast to conventional polyethylene, the Vivacit-E material is delamination resistant and exhibits a

#### Device Description:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

{2}------------------------------------------------

K122529(³/₃)

reduction in wear according to knee simulator bench testing.

Bench testing outlined in table 1, below, was conducted according to FDA guidance documents:

| Property or<br>Characteristic | Test Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Effect of prolonged aging on the wear<br>performance of vitamin-E IT Liner | Demonstrated that prolonged accelerated aging does<br>not significantly affect wear performance of Vivacit<br>E material. |
| Evaluation of the Delamination<br>Resistance of Vivacit-E Ultra High<br>Molecular Weight Polyethylene | Demonstrated that Vivacit E material is delamination<br>resistant. |
| Wear Testing of Zimmer<br>Unicompartmental Knee (ZUK) Vivacit-E<br>UHMWPE Articular Surfaces under<br>Load and Motion Curves from the ISO-<br>14243 Standard, Report | Demonstrated that the wear characteristics of the<br>Zimmer Unicompartmental Knee Vivacit-E articular<br>surfaces are sufficient to survive expected in vivo<br>loading conditions. |
| Fatigue Evaluation of the Zimmer<br>Unicompartmental Knee (ZUK) Vivacit-E<br>UHMWPE Articular Surface Locking<br>Mechanism | Demonstrated adequate resistance of the modular<br>articular surfaces to disassembly. |
| ZUK VE Posterior Edge Crush Fatigue<br>Strength Evaluation | Demonstrated posterior edge crush fatigue strength<br>is sufficient to survive expected in vivo loading<br>conditions. |
| Human Factors Comparison of Manual<br>Assembly of the Zimmer<br>Unicompartmental Knee (ZUK) Vivacit-E<br>UHMWPE Articular Surfaces | Demonstrated that assembly force required to insert<br>the Zimmer Unicompartmental Knee Vivacit-E<br>articular surfaces is appropriate for users. |

### Table 1: Bench Performance Testing Overview

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### Letter Dated: November 16, 2012

Zimmer, Incorporated % Mr. Mark D. Warner Senior Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K122529

Trade/Device Name: Zimmer® Unicompartmental Knee System Vivacit-E® Articular Surface

Regulation Number: 21 CFR 888.3520

Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis

Regulatory Class: Class II Product Code: HSX, OIY Dated: August 17, 2012 Received: August 20, 2012

#### Dear Mr. Warner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

#### Page 2 - Mr. Mark D. Warner

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Laurence D. Coyne

- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{5}------------------------------------------------

Traditional 510(k) Premarket Notification

# Indications for Use

510(k) Number (if known): K122529

Device Name: Zimmer Unicompartmental Knee System

Indications for Use: .

-

These devices are indicated for patients with:

- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.

- Previous tibial condyle or plateau fractures with loss of anatomy or function.

- Varus or valgus deformities.

- Revision of previous arthroplasty procedures.

These devices are indicated for cemented use only.

The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Ais

(Division Sign-Off) Division of Orthopedic Devices KI22529 510(k) Number_

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)