The OPTETRAK Comprehensive 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. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

Device Description

Subject Optetrak Logic Porous Femoral Component devices are the same devices as Optetrak Logic Porous Femoral Components cleared per K123687. The purpose of this submission is to expand the indications for use for these devices to provide surgeons with the option for using them without bone cement, as with predicate devices cleared per 510(k) submission K062654.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a medical device's performance that would typically be evaluated through clinical studies involving human patients or imaging modalities. Instead, it details a 510(k) submission for a femoral knee prosthesis, focusing on demonstrating substantial equivalence to previously cleared devices.

The acceptance criteria mentioned are related to engineering and material properties, rather than diagnostic performance metrics. Specifically, the summary states:

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Porosity, pore size, and coating thickness characterization per ASTM F1854-09	Testing performed and results supported substantial equivalence.
Chemical composition and material microstructure analysis	Testing performed and results supported substantial equivalence.

No information is available regarding the following points as they are not relevant to this type of 510(k) submission, which focuses on material and engineering equivalence, not AI or clinical performance studies:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
If a standalone (algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary of the Study:

The study described is an engineering study and material analysis to demonstrate that the Exactech® Optetrak Logic® Porous Femoral Component is substantially equivalent to predicate devices. The purpose was to expand the indications for use to include cementless application.

The methods involved:

Characterization of porosity, pore size, and coating thickness according to ASTM F1854-09.
Analysis of chemical composition and material microstructure.

The conclusion drawn was that the results of these engineering studies demonstrated the proposed device's substantial equivalence to the cited cleared predicate devices (K123687 and K062654). This approach is typical for devices seeking 510(k) clearance based on demonstrating equivalence in design, materials, and mechanical properties, especially for an expanded indication for a previously cleared device.

Summary

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Exactech® Optetrak Logic® Porous Femoral Component Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

JUI 30 7014

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 327-4762 Fax: (352) 378-2617

FDA Establishment Number 1038671

Contact: Patrick Hughes Senior Regulatory Affairs Specialist
June 30, 2014 Date:

Trade or Proprietary or Model Name(s):

Exactech® Optetrak Logic® Porous Femoral Component

Common Name:

Femoral Knee Prosthesis

Classification Name:

21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Class II

21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis; Class II

Device Code: JWH, MBH

Information on devices to which substantial equivalence is claimed:

510(k)	Trade or Proprietary or Model Name	Manufacturer
K123687	Optetrak Logic Porous Femoral Components	Exactech, Inc
K062654	Sigma CR Porocoat® Femoral Components	DePuy

Indications for Use:

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K140302

Exactech® Optetrak Logic® Porous Femoral Component Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

Device Description:

Both predicate and proposed devices share the following similarities:

. the same intended use
. the same materials
the same basic fundamental scientific technology .
. the same materials and processes used for packaging and sterilization

Summary of Testing:

. Porosity, pore size, and coating thickness characterization per ASTM F1854-09
Chemical composition and material microstructure analysis .

Substantial Equivalence Conclusion:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 30, 2014

Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K140302

Trade/Device Name: Exactech® Optetrak Logic® Porous Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: July 2, 2014 Received: July 7, 2014

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 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

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the circle is an emblem that resembles an eagle.

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Page 2 - Mr. Patrick Hughes

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Lori A. Wigqins

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

Enclosure

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Exactech® Optetrak Logic® Porous Femoral Component Traditional 510(k) - Indications for Use

K140302 510(k) Number:

Device Name: Exactech® Optetrak Logic® Porous Femoral Component

INDICATIONS

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)

Casey L. Hanley, Ph.D
Division of Orthopedic Devices

Page 1 of 1

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.