OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T

K093360 · Exactech, Inc. · JWH · Jan 11, 2010 · Orthopedic

Device Facts

• Record ID: K093360
• Device Name: OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
• Applicant: Exactech, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 11, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optetrak Logic Total Knee System is 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. The Optetrak Logic Total Knee System is indicated for cemented use only.

Device Story

The Optetrak Logic Total Knee System is a cemented total knee prosthesis consisting of femoral components, tibial trays, and tibial inserts. It serves as a modification to existing Optetrak system components. The device is intended for surgical implantation by orthopedic surgeons in a hospital setting to replace damaged knee joints. By providing a semi-constrained mechanical interface, the system restores joint function, reduces pain, and improves mobility for patients suffering from degenerative knee conditions. The device is implanted during primary or revision total knee arthroplasty procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cemented, semi-constrained knee prosthesis. Components include femoral, tibial tray, and tibial insert modifications. Materials, sterilization, and packaging processes are identical to previously cleared Optetrak system components.

Indications for Use

Indicated for skeletally mature individuals undergoing primary total knee replacement or revision of failed reconstructions due to osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative conditions, provided sufficient bone stock and soft tissue integrity exist. 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

• Optetrak Total Knee Trapezoidal Cemented Tibial Components (K933610)
• Optetrak Total Knee System Cruciate Retained Titanium Back Tibial Components (K932776)
• Optetrak Total Knee System Hi-Flex Knee Components (K033883)
• Optetrak Posterior Stabilized Cemented Total Knee (K933494)
• Optetrak Asymmetric Femoral Component (K032606)

Submission Summary (Full Text)

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K093360 *1/2

# Exactech® Optetrak® Logic™ Total Knee System Special 510(k) - 510(k) Summary of Safety and Effectiveness

| Sponsor: | Exactech® Inc.<br>2320 N.W. 66th Court<br>Gainesville, FL 32653 | JAN 1 1 2010 |
|----------|-----------------------------------------------------------------|--------------|
| | Phone: [phone]<br>Fax: [phone] | |
| | FDA Establishment Number 1038671 | |
| Contact: | Patrick Hughes<br>Regulatory Affairs Specialist | |
| Date: | January 6. 2010 | |

Trade or Proprietary or Model Name(s): Exactech® Optetrak® Logic™ Total Knee System

Common Name:

Cemented Total Knee Prosthesis

# Classification Name:

Knee joint patellofemorotibial polymer semi-constrained cemented cemented prosthesis

# Information on devices to which Substantial equivalence is claimed:

| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---------------|---------------------------------------------------------------------------------|----------------|
| K933610 | Optetrak Total Knee Trapezoidal Cemented<br>Tibial Components | Exactech, Inc. |
| K932776 | Optetrak Total Knee System Cruciate<br>Retained Titanium Back Tibial Components | Exactech, Inc. |
| K033883 | Optetrak Total Knee System Hi-Flex Knee<br>Components | Exactech, Inc. |
| K933494 | Optetrak Posterior Stabilized Cemented<br>Total Knee | Exactech, Inc. |
| K032606 | Optetrak Asymmetric Femoral Component | Exactech, Inc. |

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K093360 #2/2

# Exactech® Optetrak® Logic™ Total Knee System Special 510(k) - 510(k) Summary of Safety and Effectiveness

#### Indications for Use:

The Optetrak Logic Total Knee System is 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.

The Optetrak Logic Total Knee System is indicated for cemented use only.

#### Device Description:

The proposed Optetrak Logic. Total Knee System half-size finned and trapezoidal tibial trays are modifications to the existing Optetrak Total Knee System Cruciate Retained Titanium Back Tibial. Components (K932776) and Optetrak Total Knee Trapezoidal Cemented Tibial Components (933610), respectively. The proposed Optetrak Logic Total Knee System tibial inserts and femoral components are modifications to the existing Optetrak Total Knee System Hi-Fiex Knee Components (K033883).

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

- the same indications for use .
- similar design features .
- . incorporate the same materials
- the same shelf life .
- . are packaged and sterilized using the same materials and processes.

#### Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic Total Knee System devices are substantially equivalent to cited cleared predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Exactech Inc. % Mr. Patrick Hughes 2320 N.W. 66th Court Gainesville, Florida 32653

JAN 1 1 2010

Re: K093360 Trade/Device Name: Exactech® Optetrak® Logic™ 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: December 09, 2009 Received: December 14, 4009

Dear Mr. Hughes:

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 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 of medical 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.

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Page 2 - Mr. Patrick Hughes

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/ReportalProblem/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,

Barbara Buckner
for

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

Enclosure

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# Exactech® Optetrak® Logic™ Total Knee System Special 510(k) - Indications for Use

#### 510(k) Number: K093360

# Device Name: Exactech® Optetrak® Logic™ Total Knee System

### INDICATIONS

The OPTETRAK Logic Total Knee System is 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.

The OPTETRAK Logic Total Knee System is indicated for cemented use only.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | and/or | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
|-------------------------------------------------|--------|------------------------------------------------|
| X | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omuta for mxm

(Division Sign4 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093360