MODIFICATION TO VKS KNEE SYSTEM

K023416 · Plus Orthopedics · JWH · Nov 8, 2002 · Orthopedic

Device Facts

• Record ID: K023416
• Device Name: MODIFICATION TO VKS KNEE SYSTEM
• Applicant: Plus Orthopedics
• Product Code: JWH · Orthopedic
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.

Device Story

The VKS Knee System is a semi-constrained, cemented knee joint prosthesis. This modification incorporates the TC-PLUS patella component into the existing VKS system. The device is intended for use by orthopedic surgeons in clinical settings for total knee arthroplasty. It functions as a surface replacement to restore joint function in patients with specific orthopedic conditions. The system is designed to provide stability and articulation in the knee joint.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semi-constrained, cemented knee joint prosthesis; polymer/metal/polymer construction. Designed for primary and revision total knee arthroplasty.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty with minimal bone loss and intact collateral ligaments. Contraindicated in cases of significant bone loss or ligamentous deficiency due to tumor, trauma, infection, or connective tissue disorders.

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

• TC-Plus Knee System (K000666)
• VKS Knee System (K022204)

Submission Summary (Full Text)

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

K023416
page 1 of 1

## NOV 8 2002

## 510(k) Summary of Safety and Effectiveness

Contact:

PLUS ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121 Tel: [phone] x 2506

Trade name: VKS Knee System

Common name: Knee Joint Prosthesis

Classification Prosthesis, Knee Patellofemoratibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 888.3860, 87 JWH name:

Equivalence: TC-Plus Knee System, K000666/VKS Knee System K022204

Device Modification Use the TC-PLUS patella with the VKS Knee System. Description:

Indications:

The VKS Knee System is intended as a cemented surface

replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 8 2002 NOV

Ms. Louise Focht Consultant PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121-2700

Re: K023416

Trade/Device Name: VKS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: October 10, 2002 Received: October 11, 2002

Dear Ms. Focht:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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

Page 2 - Ms. Louise Focht

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark A. Millburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SPECIAL 510(K) DEVICE MODIFICATION VKS Knee System October 10, 2002

> Page 1 - of

K023416 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name(s): VKS Knee System

Indications for Use:

The VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) <div>Division of General, Restorative</div> <div>and Neurological Devices</div> |
|---------------|-----------------------------------------------------------------------------------------------------|
| 510(k) Number | K023416 |

| Prescription Use | OR | Over-The-Counter-Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional format 1-2-96) |