OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT

K111400 · Exactech, Inc. · JWH · Jul 28, 2011 · Orthopedic

Device Facts

• Record ID: K111400
• Device Name: OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
• Applicant: Exactech, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 28, 2011
• 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. In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

Device Story

The Optetrak Logic CR Knee System is a cemented total knee prosthesis consisting of femoral components and tibial inserts. It is used by orthopedic surgeons in a clinical/OR setting to replace damaged knee joints. The device functions as a semi-constrained implant to restore joint function. The system is a modification of existing cleared Optetrak components. The surgeon selects and implants the components to replace the articular surfaces of the knee, aiming to alleviate pain and improve mobility for patients with degenerative joint disease. The device is intended for permanent implantation.

Clinical Evidence

Bench testing only. Evidence includes engineering drawing comparisons to mating components and Finite Element Analysis (FEA) to compare contact stresses of the modified femoral components and tibial inserts against predicate devices.

Technological Characteristics

Cemented, semi-constrained patellofemorotibial prosthesis. Materials: metal/polymer. Design: modification of existing Optetrak femoral components and tibial inserts. Connectivity: N/A. Sterilization: same as predicate processes.

Indications for Use

Indicated for skeletally mature individuals undergoing primary total knee replacement for osteoarthritis, osteonecrosis, rheumatoid arthritis, or post-traumatic degenerative conditions; also indicated for revision of failed reconstructions with sufficient bone stock and soft tissue integrity. 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 Cruciate Retaining Cemented Total Knee System (K932690)
• Optetrak Logic Total Knee System (K093360)
• Optetrak CR Slope (K082022)

Submission Summary (Full Text)

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

JUL 2 8 2011

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653

e, FL 32655

[phone]

Phone: [phone] Fax: [phone]

FDA Establishment Number 1038671

- Contact: Patrick Hughes Regulatory Affairs Specialist
May 17, 2011 Date:

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

Common Name: Cemented Total Knee Prosthesis

#### Classification Name:

21 CFR 888.3560 - Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis.

Product Code: JWH - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

FDA Classification: Class II

#### Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---------------|--------------------------------------------------------|----------------|
| K932690 | Optetrak Cruciate Retaining Cemented Total Knee System | Exactech, Inc. |
| K093360 | Optetrak Logic Total Knee System | Exactech, Inc. |
| K082022 | Optetrak CR Slope | Exactech, Inc. |

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KIILOD

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## Exactech® Optetrak® Logic® CR 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.

In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

### Device Description:

Proposed Optetrak Logic CR Knee System femoral components are modifications to existing femoral components cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak Logic Total Knee System 510(k) #K093360.

Proposed Optetrak Logic CR Knee System tibial inserts are modifications to existing tibial inserts cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak CR Slope 510(k) #K082022.

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 .
- the same design features .
- . the same materials
- the same shelf life .
- . packaging and sterilization using the same materials and processes
- compatible with the same corresponding Optetrak tibial trays ●

The Optetrak Logic CR Knee System is not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

### Performance Data

Table 1 shows performance data provided, cited, or referenced in this submission to support a conclusion of substantial equivalence:

| Evaluation | Activities Performed |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Logic CR insert/femoral component<br>compatibility | Engineering drawing comparison to mating components and equivalent<br>predicates |
| Logic CR insert/tibial tray<br>compatibility | Engineering drawing comparison to mating components and equivalent<br>predicates |
| Tibial insert scope addition<br>mechanical properties | Engineering evaluation using Finite Element Analysis to compare contact<br>stresses with predicates |
| Femoral component scope addition<br>equivalency | Engineering drawing comparison to mating components and equivalent<br>predicates |
| Femoral component design<br>modification | Engineering evaluation using Finite Element Analysis to compare contact<br>stresses with predicates |

#### Table 1: Optetrak Logic CR Performance Data

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

## Substantial Equivalence Conclusion:

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

> KI|1400 Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with three flowing lines, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Exactech, Inc. % Mr. Patrick Hughes Re1g4ulatory Affairs Specialist 2320 NW 66" Court Gainesville, Florida 32653

JUL 28 2011

Re: K111400

Trade/Device Name: Exactech® Optetrak® Logic® CR 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: July 18, 2011 Received: July 20, 2011

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. 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

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### Page 2 - Mr. Patrick Hughes

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

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.

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

Sincerely yours,

Mark M. Milkerson

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® CR Knee System Special 510(k) - Indications for Use

| 510(k) Number: | K111400 |
|----------------|---------|
|----------------|---------|

# Device Name: Exactech® Optetrak® Logic® CR 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, theumatoid 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.

In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tor m. melkerson

(Division Sign Off) (Division Sign Off)
Division of Surgical, Orthopedic, Orthopedic, Devices Division ODSurgious, and Restorative Devices

510(k) Number R111400