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 size 0 and size 6 Optetrak Logic CR Knee System components are line extensions to the Optetrak Logic CR Knee System cleared per 510(k) #K111400.

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 Logic tibial trays .

The size 0 and 6 Optetrak Logic CR Knee System components are not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

AI/ML Overview

This document describes a 510(k) submission for a medical device, specifically a knee replacement system, and does not involve any AI/ML components or software. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML is not applicable to this input.

The document focuses on demonstrating substantial equivalence of new sizes (0 and 6) of the Exactech® Optetrak® Logic® CR Knee System to a previously cleared predicate device (K111400). The "Performance Data" section explicitly states that mechanical testing was used to assess and compare peak contact pressures, implying physical testing of the knee implant components rather than an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these concepts are specifically related to the evaluation of AI/ML-driven devices.

Summary

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K121307(1/2)

Exactech® Optetrak® Logic® CR Knee System, Sizes 0 and 6 Special 510(k) - 510(k) Summary of Safety and Effectiveness

MAY 3 1 2012

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 Fax: (352) 378-2617

FDA Establishment Number 1038671 .

Patrick Hughes Contact: Regulatory Affairs Specialist
April 27, 2012 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/metal/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
K111400	Optetrak Logic CR Knee System	Exactech

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K121307(²/₂)

Exactech® Optetrak® Logic® CR Knee System, Sizes 0 and 6 Special 510(k) - 510(k) Summary of Safety and Effectiveness

Indications for Use:

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

Device Description:

Proposed size 0 and size 6 Optetrak Logic CR Knee System components are line extensions to the Optetrak Logic CR Knee System cleared per 510(k) #K111400.

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 Logic tibial trays .

The size 0 and 6 Optetrak Logic CR Knee System components are not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

Performance Data

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

Table 1: Optetrak Logic CR Performance Data

Evaluation	Activities Performed
Logic CR size 0 and size 6 (11mm) insert performance equivalency	Mechanical testing to assess and compare peak contact pressures.
Logic CR size 6 (9mm) insert performance equivalency	Mechanical testing to assess and compare peak contact pressures.

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate proposed size 0 and size 6 Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAY 3 1 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-00002

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

Re: K121307

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: April 27, 2012 Received: May 1, 2012

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 (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.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

erely yours,
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® CR Knee System, Sizes 0 and 6 Special 510(k) - Indications for Use

510(k) Number: K121307

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, 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.

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)

A.t.Snt.

(Division Sign-Off) Division of Surgical. "irthopedic, and Restorative Devices

510(k) Number K121307

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.