OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS

K032606 · Exactech, Inc. · JWH · Sep 23, 2003 · Orthopedic

Device Facts

• Record ID: K032606
• Device Name: OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS
• Applicant: Exactech, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optetrak Femoral components are intended to replace the patient's distal femur during primary or revision total knee arthroplasty. The Optetrak® Asymmetric Femoral components are intended for use when needed to more closely match the geometry of the patient's resected distal femur. This change results in separate components for the right and left knees. The Asymmetric, Cruciate-Retaining Cemented components and the Asymmetric, Cruciate-Retaining, Porous-Coated Femoral Components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) is preserved. The Optetrak® Size 6 Posterior-Stabilizing, Cemented Femoral Component and Asymmetric, Posterior-Stabilizing Femoral components are intended to replace the function of the PCL during a total knee arthroplasty in which the PCL must be sacrificed. All proposed femoral components are intended for cemented use only.

Device Story

Optetrak® Total Knee System femoral components; line extension including asymmetric femoral components and larger size 6 posterior-stabilized component. Asymmetric design features tilted lateral flange and angled proximal edge to match patient distal femur geometry; size 6 component features increased anterior-posterior and medial-lateral dimensions. Used by orthopedic surgeons in clinical settings for primary or revision total knee arthroplasty. Components replace distal femur; posterior-stabilized versions replace PCL function. Cemented use only. Benefits include improved anatomical fit and accommodation of larger patient anatomy.

Clinical Evidence

No clinical data. Verification and validation analyses were conducted via bench testing to confirm implant performance is adequate for anticipated in vivo loading.

Technological Characteristics

Femoral components for total knee arthroplasty. Materials: Metal/Polymer (implied by classification). Design: Asymmetric patellar flange (tilted lateral, angled proximal edge) and increased size 6 geometry. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for skeletally mature individuals undergoing primary total knee replacement for osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative problems; also for revision of failed previous reconstructions with sufficient bone stock and soft tissue integrity. Contraindicated in patients with active infection, insufficient bone stock/soft tissue integrity, mental/neuromuscular disorders preventing joint control, or conditions causing extreme loads/early failure.

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

• Optetrak® Cruciate Retaining Cemented Femoral Component (K932690)
• Optetrak® Posterior Stabilizing Cemented Femoral Component (K933494)
• Optetrak® Cruciate Retaining Porous-Coated Femoral Component (K935726)
• Optetrak® Size 0 and 1 Delta Line Extension (K011976)

Submission Summary (Full Text)

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

# KO32606

SEP 2 3 2003

## Exactech® Optetrak® Total Knee System Line Extension - Optetrak® Femoral Components Special 510(k)

### Summary of Safety and Effectiveness

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653 Phone: [phone] [phone] Fax:

FDA Establishment Number: 1038671

- Contact: Dr. Gary Miller Vice President of Research and Development
Date:

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

## 1032606

## Exactech® Optetrak® Total Knee System Line Extension - Optetrak® Femoral Components Special 510(k)

#### Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Classifications / Proprietary Names: Prosthesis, Knee, Patellofemorotibial, Semi-Classification Name: Constrained, cemented, Polymer/Metal/Polymer Optetrak® Total Knee System Trade / Proprietary Model Name: · Asymmetric Femoral Components · Size 6 Posterior-Stabilizing, Cemented Femoral Component JWH Product Code: C.F.R. Section: 888.3560 II Device Class: Orthopedic Classification Panel:

#### Exactech® Legally Marketed Devices for Substantial Equivalence Comparison:

| Model | 510(k) Number |
|--------------------------------------------------------------|---------------|
| Optetrak® Cruciate Retaining Cemented Femoral Component | K932690 |
| Optetrak® Posterior Stabilizing Cemented Femoral Component | K933494 |
| Optetrak® Cruciate Retaining Porous-Coated Femoral Component | K935726 |
| Optetrak® Size 0 and 1 Delta Line Extension | K011976 |

#### Device Information:

#### INTENDED USE

The Optetrak Femoral components are intended to replace the patient's distal femur during primary or revision total knee arthroplasty. The Optetrak® Asymmetric Femoral components are intended for use when needed to more closely match the geometry of the patient's resected distal femur. This change results in separate components for the right and left knees. The Asymmetric, Cruciate-Retaining Cemented components and the Asymmetric, Cruciate-Retaining, Porous-Coated Femoral Components are intended for

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

# 2032606

## Exactech® Optetrak® Total Knee System Line Extension - Optetrak® Femoral Components Special 510(k)

### Summary of Safety and Effectiveness

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) is preserved.

The Optetrak® Size 6 Posterior-Stabilizing, Cemented Femoral Component and Asymmetric, Posterior-Stabilizing Femoral components are intended to replace the function of the PCL during a total knee arthroplasty in which the PCL must be sacrificed.

All proposed femoral components are intended for cemented use only.

#### INDICATIONS

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

#### CONTRAINDICATIONS

The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

CAUTION: In the USA, for cemented use only.

#### Device Modifications

The device modifications presented in this Special 510(k) represent changes to the posterior stabilized, cruciate-retaining cemented, and cruciate-retaining porous coated femoral components of the Optetrak® Total Knee System (K932690, K933494, K935726, K011976). These changes include:

- 1. Modification of the patellar flange to create an asymmetric femoral component
- 2. Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component

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

## Exactech® Optetrak® Total Knee System Line Extension - Optetrak® Femoral Components Special 510(k)

#### Summary of Safety and Effectiveness

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

No changes were made to the tibial or patellar components of the Optetrak® Total Knee System.

#### Device Modifications - Optetrak® Asymmetric Femoral Components (Optetrak® AK):

The differences in design features between the proposed Optetrak AK Femoral and predicate Optetrak® Femoral include the following:

- 1. Changes to the anterior flange to make the component asymmetric by:
- a. Tilting the flange laterally, and
- b. Angling the proximal edge of the flange medially.
- 2. Adjustments to the patella groove edges by:
- a. Increasing the edge radii resulting from the intersections of the patella groove and the trochlear condyles to smooth the edges, and
- b. Slightly lowering the profile height of the medial trochlear condyle in the proximal area as a result of the tilting of the flange.

#### Device Modifications - Optetrak® Size 6 Posterior-Stabilized, Cemented Femoral Component:

The difference in design between the proposed size 6 femoral component and the predicate femoral components consists of a size increase in the overall geometry of the component. resulting in:

- 1. An increase in the overall anterior-posterior dimension of four (4) millimeters
- 2. An increase in the overall medial-lateral dimension of five (5) millimeters

#### PERFORMANCE DATA SUMMARY

Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading.

We conclude that the Optetrak® Asymmetric Femoral Components and the Size 6 Posterior-Stabilizing Cemented Femoral Component are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak® femoral components.

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

Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text is partially obscured but appears to read "HEALTH & HUMAN SERVICES - USA". The bird-like symbol consists of three curved lines that resemble wings or feathers, creating a sense of movement or flight. The logo is in black and white and has a slightly distressed or aged appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Mr. Martin Sprunck Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653

Re: K032606

Trade/Device Name: OPTETRAK® Total 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: August 20, 2003 Received: August 25, 2003

Dear Mr. Sprunck:

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 lisuing (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.

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

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark A. Melkerson

'elia 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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a handwritten alphanumeric string. The string is 'K032606'. The characters are written in a simple, slightly slanted style, with each character clearly distinguishable.

## Exactech® Optetrak® Total Knee System Line Extension - Optetrak® Femoral Components Special 510(k)

#### Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Number:

032606

Device Name:

INDICATIONS

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

#### CONTRAINDICATIONS

The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

CAUTION: In the USA, for cemented use only.

Mark A. Mellem

Division of General, I morative and Neurological Devi.es

510(k) Numl er

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over the Counter Use

Section 3 Page 1 of 1