Klassic Knee System

K153310 · Total Joint Orthopedics, Inc. · JWH · Dec 17, 2015 · Orthopedic

Device Facts

• Record ID: K153310
• Device Name: Klassic Knee System
• Applicant: Total Joint Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 17, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following: - Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis - Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis - Patients with failed previous surgery where pain, deformity, or dysfunction persists - Correctable varus-valgus deformity and moderate flexion contracture - Revision of a previously failed knee arthroplasty - Patients who require a total knee replacement

Device Story

Klassic® Knee System is a cemented, modular total knee replacement prosthesis; components include femoral, tibial, and patellar elements. Device is used in orthopedic surgery to replace damaged knee joints; restores joint function and reduces pain. Surgeon selects appropriate modular component sizes based on patient anatomy. Size 7 femoral component added to existing system. Components manufactured from Cobalt-Chromium Alloy. Device implanted in OR by orthopedic surgeon. Benefits include improved mobility and pain relief for patients with degenerative or inflammatory joint disease.

Clinical Evidence

No clinical data. Substantial equivalence is based on engineering analyses and bench-top verification activities.

Technological Characteristics

Cemented, modular total knee replacement system. Components manufactured from Cobalt-Chromium Alloy. Design features include varying sizes for modularity. Semi-constrained patellofemorotibial prosthesis. Class II device per 21 CFR 888.3560.

Indications for Use

Indicated for patients requiring total knee replacement due to non-inflammatory degenerative joint disease (avascular necrosis, osteoarthritis), inflammatory joint disease (rheumatoid arthritis), failed previous surgery, or revision of failed knee arthroplasty; includes patients with correctable varus-valgus deformity and moderate flexion contracture.

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

• Klassic® Knee System (K112906)

Submission Summary (Full Text)

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

Image /page/0/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" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, representing the department's focus on people and their well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2015

Total Joint Orthopedics, Incorporated Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106

Re: K153310 Trade/Device Name: Klassic® Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 16, 2015 Received: November 17, 2015

Dear Mr. Weaber:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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

## Indications for Use

510(k) Number (if known) K153310

Device Name Klassic® Knee System

## Indications for Use (Describe)

The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:

- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

#### 5. 510(k) Summary

| Manufacturer: | Total Joint Orthopedics, Inc.<br>1567 E. Stratford Avenue<br>Salt Lake City, UT 84106<br>Phone: [phone]<br>Fax: [phone] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber<br>Manufacturing Development Engineer |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street, NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | November 16, 2015 |
| Device Trade Name: | Klassic® Knee System |
| Device Common Name: | Total knee replacement system |
| Classification: | 21 CFR 888.3560 – Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented |
| | Class II |
| Product Code: | JWH |

## Indications for Use:

The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement in treatment of the following:

- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): o avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis ●
- Patients with failed previous surgery where pain, deformity, or dysfunction . persists
- Correctable varus-valgus deformity and moderate flexion contracture ●
- Revision of a previously failed knee arthroplasty
- Patients who require a total knee replacement ●

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

## Device Description:

The Klassic® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to expand the size offerings of the Klassic® Knee System to include a Size 7 femoral component. These components are manufactured from Cobalt-Chromium Alloy.

## Predicate Devices:

The modified Klassic® Knee System is substantially equivalent to the predicate Klassic® Knee System (K112906) with respect to indications, design, and function. The information summarized in the Design Control Activities Summary demonstrates that the Klassic Knee Femur, Size 7, met the pre-determined acceptance criteria for the verification activities.

## Substantial Equivalence:

Engineering analyses were performed on the Klassic Knee Femur, Size 7, and the previously cleared femurs to evaluate the Tibial-Femoral Instability and Contact Stress and Patella-Femoral Instability and Contact Stress. The results of these analyses indicate that the Size 7 Klassic Knee Femurs are substantially equivalent to the predicate components.