ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED

K020383 · Ortho Development Corp. · JWH · May 6, 2002 · Orthopedic

Device Facts

• Record ID: K020383
• Device Name: ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
• Applicant: Ortho Development Corp.
• Product Code: JWH · Orthopedic
• Decision Date: May 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.

Device Story

Balanced Knee™ Tibial Tray Pegged is a component of the Balanced Knee™ System; serves as a replacement for diseased/arthritic knees. Device is a metal tibial tray manufactured from forged Ti-6Al-4V ELI alloy with a porous coating. It features distal pegs for fixation, replacing screws used in other configurations. Used by orthopedic surgeons in clinical settings for primary total knee replacement. Device provides structural support and restoration of joint function. Clinical benefit includes pain relief and improved mobility for patients with severe knee degeneration. Substantially equivalent to existing Balanced Knee™ System configurations; utilizes identical locking mechanisms for UHMWPE inserts and identical material specifications.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on non-clinical performance data and design comparisons to the predicate Balanced Knee™ System (K994370).

Technological Characteristics

Material: Forged Ti-6Al-4V ELI alloy with CP Titanium porous coating. Design: Tibial tray with distal pegs. Sterilization: Gamma radiation (ANSI/AAMI/ISO 11137-1994). Fixation: Cemented. Software: None.

Indications for Use

Indicated for patients with severe knee pain and disability requiring femoral, tibial, and patellar replacement due to degenerative bone disease (rheumatoid/osteoarthritis), traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, pseudo-gout, or prior prosthesis complications. Also indicated for loss of joint function/configuration and moderate valgus, varus, or flexion deformities. Intended for cemented use only.

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

• Balanced Knee™ System (K994370)
• Natural Knee System (Intermedics Orthopedics)
• Ortholoc Advantim System (Wright Medical)
• Consensus Knee System (Hayes Medical)

Submission Summary (Full Text)

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

Premarket Notification for Balanced Knee™ Tibial Tray Pegged

MAY 06 2002
Page 1 of 2

## SUMMARY OF SAFETY AND EFFECTIVENESS:

This safety and effectiveness summary for the Ortho Development Balanced Knee™ Tibial Tray Pegged is provided as required per Section 513(i)(3) of the Food, Drug, and Cosmetic Act.

### 1. Submitter:

Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

- 2. Contact Person: Carol Freasier Telephone: [phone] Fax: [phone]
- 3. Date Prepared: February 4, 2002

#### Name of the Device 4.

| Trade Name: | Ortho Development Balanced Knee™ Tibial Tray Pegged |
|----------------------|--------------------------------------------------------------------------------------------|
| Proprietary Name: | Balanced Knee™ Tibial Tray Pegged |
| Common Name: | Balanced Knee™ Tibial Tray Pegged |
| Classification Name: | Prosthesis, Knee patellofemorotibial, Semi-constrained, Cemented,<br>Polymer/Metal/Polymer |
| Reference: | (888.3560) |

#### Predicate or legally marketed devices which are substantially equivalent: 5.

- Balanced Knee™ System (Ortho Development) .
- Natural Knee System (Intermedics Orthopedics) .
- Ortholoc Advantim System (Wright Medical) .
- Consensus Knee System (Hayes Medical) .

### 6. Description of the device:

The Ortho Development Balanced Knee™ Tibial Tray Pegged serves as an additional option to the tibial tray configurations currently offered in the Ortho Development Balanced Knee™ System, K994370, which include the tibial tray nonporous and the tibial tray porous.

The devices are manufactured from forged Ti-6AI-4V ELI alloy and coated with CP Materials: Titanium per ASTM standards.

The Tibial Tray Pegged functions to provide restoration of function as a replacement for Function: diseased and arthritic knees as part of the Ortho Development Balanced Knee™ System.

#### 7. Intended Use:

The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.

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

11 12

K020383 page dot 2

#### Comparison of the technological characteristics of the device to predicate and legally 8. marketed Ortho Development Balanced Knee™ System:

There are no significant differences between the Ortho Development Balanced Knee™ Tibial Tray Pegged and the Ortho Development Balanced Knee™ System currently being marketed which would adversely affect the use of the product. It is substantially equivalent to this device in design, function, material and intended use.

| Parameter | Identical, Similar or Different | Similarities and Differences |
|-----------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Identical | • Both the predicate and the proposed devices have the same profile and keel geometry. |
| | Identical | • Both the predicate and the proposed devices incorporate the same locking mechanism to secure the UHMWPE insert. |
| | Identical | • Both the predicate and the proposed devices have the same surface finish specifications. |
| | Similar | • The proposed devices has pegs on the distal surface in place of screws on the tibial tray porous. |
| Materials | Identical | • Ti-6Al-4V ELI Alloy for both the predicate and the proposed devices. |
| | Identical | • Porous coating for both the predicate and the proposed devices. |
| Manufacturing Process | Identical | • Both the predicate and the proposed devices are machined from near net forgings. |
| | Identical | • Both the predicate and the proposed devices are porous coated using the same material specification and process. |
| Biocompatibility | Identical | • The materials used meet or exceed ASTM standards, are common to orthopedic products today, and leave an extensive safe clinical history. |
| Pyrogenicity | Identical | • Neither the predicate or the proposed devices are labeled as nonpyrogenic, Per USP XXII, NF18 (1995 edition), page 1719, "These requirements do not apply to orthopedic products." |
| Sterility | Identical | • Both the predicate and the proposed devices are terminally sterilized by gamma radiation. Gamma radiation processing and dose mapping are conducted according to ANSI/AAMI/ISO 11137-1994. The products are accepted for release as sterile though a validated dosimetric release program designed to provide a sterility assurance level (SAL) of 10-6 or better (ANSI/AAMI/ISO 11137-1994, ANSI/AAMI ST32-1991 and ISO/TR 13409-1996) |

### 9. Non-clinical Performance and Conclusions:

Addressed in the Ortho Development Balanced Knee™ System, K994370

- 10. Clinical Performance and Conclusions:
Clinical data and conclusion were not needed for this device.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 6 2002

Ms. Carol Freasier Regulatory Affairs/Quality Assurance Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020

Re: K020383

Trade/Device Name: Ortho Development Balanced Knee™ Tibial Tray Pegged Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 4, 2002 Received: February 5, 2002

Dear Ms. Freasier:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Carol Freasier

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 yours,

for Mark Milliken

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

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

#### K020383 510(k) Number (if known):

page 1 of 1

Device Name: Balanced Knee™ Tibial Tray Pegged

### Indications for Use

The Balanced Knee™ Tibial Tray Pegged is intended for single use in primary total knee replacement only. Indications include:

- Loss of joint configuration and joint function; .
- Osteoarthritis of the knee joint; .
- Rheumatoid arthritis of the knee joint; .
- Post-traumatic arthritis of the knee joint; ♥
- Moderate valgus, varus, or flexion deformities. #

The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee pain and disability. Specific indications include fomoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudogout, or complications from a previous prosthesis. This device is intended for cemented use only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


*for* (Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K020383 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|---------------------------------------------------|----|-----------------------------------------------|
|---------------------------------------|---------------------------------------------------|----|-----------------------------------------------|