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 System is indicated for cemented use only.

Device Description

The proposed Optetrak Logic 17mm & 19mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UHMWPE) tibial insert components cleared per 510(k)s K093360. K110547. K111400. K121307, and K123342.

This submission proposes adding 17mm and 19mm tibial insert options to the existing 9mm-15mm range of Optetrak Logic insert thicknesses. The 17mm and 19mm thick inserts will be provided across the current component size range (size 0 through size 6). Like the predicate devices, the proposed inserts are used in total knee arthroplasty (TKA) with metal femoral components and tibial trays. The thicker inserts are proposed for both posterior-stabilized (Logic PS, Logic PSC) and cruciate-retaining (Logic CR. Logic CRC) product options.

AI/ML Overview

The provided text describes a 510(k) submission for Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts, which are modifications to existing tibial inserts for total knee arthroplasty (TKA). The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Evaluation)	Reported Device Performance (Activity)
Locking stability	Anterior/posterior liftoff/dissociation testing

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "engineering studies" and "non-clinical performance data" but does not specify sample sizes for the test set or directly refer to a "test set" in the context of clinical data or human subjects. The evaluation is focused on the device's mechanical properties. The data provenance is non-clinical testing performed by the manufacturer,Exactech, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the provided text describes non-clinical engineering testing. There is no mention of human experts establishing ground truth for a clinical test set.

4. Adjudication Method for the Test Set:

This information is not applicable as the assessment is based on non-clinical engineering tests, not on human interpretation or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a medical device modification, and the provided text focuses on engineering studies, not clinical effectiveness studies involving human readers and interpretations.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

This information is not applicable. The device is a physical medical implant (tibial insert), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance data is derived from the results of mechanical and physical testing (e.g., anterior/posterior liftoff/dissociation testing) designed to assess the locking stability of the tibial inserts. This is based on established engineering principles and test methods for medical devices.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical implant and does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no "training set" for this type of medical device submission.

Summary

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Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Traditional 510(k) - 510(k) Summary

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

Phone: (352) 327-4762 (352) 378-2617 Fax:

FDA Establishment Number 1038671

Contact: Patrick Hughes Senior Regulatory Affairs Specialist

Date: July 10. 2013

OCT 1 1 2013

Trade of Proprietary or Model Name(s): Exactech Optetrak Logic 17mm & 19mm Thick Inserts

Common Name:

Total Knee Arthroplasty - Tibial Inserts

Classification Name:

Cemented total knee prosthesis (CFR 888.3560, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Class II, Product Code JWH)

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary or Model Name	Manufacturer
K093360	Optetrak Logic PS	Exactech, Inc.
K110547	Optetrak Logic PSC	Exactech, Inc.
K111400	Optetrak Logic CR	Exactech, Inc.
K121307	Optetrak Logic CR Sizes 0 & 6	Exactech, Inc.
K123342	Optetrak Logic CRC	Exactech, Inc.
K933610	Exactech Cemented Total Knee SystemTibial Components	Exactech, Inc.
K932776	Optetrak Cruciate Retaining TibialComponents	Exactech, Inc.

Indications for Use:

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

Page 1 of 2 Section 8

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K132161

Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Traditional 510(k) - 510(k) Summary

Device Description:

Comparison of Technological Characteristics

The predicate and proposed devices have the same intended use and basic fundamental scientific technology. The intended use of the modified device, as described in the labeling, has not changed as a result of the proposed modifications. The modified devices share the following similarities with the predicate devices:

. Indications for use
Design features (including mating geometry, locking mechanism, and . articulating geometry)
. Material (UHMWPE per ASTM F648)
o 8-year shelf life
o Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10th
. Use at the same site in the body for the same purpose (TKA)

The proposed components are not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

Non-Clinical Performance Data

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

Table 1: Optetrak Logic 17mm & 19mm Thick Tibial Inserts Testing

Evaluation	Activity
Locking stability	Anterior/posterior liftoff/dissociation testing

Substantial Equivalence Conclusion:

Comparison analysis and results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic 17mm Thick Tibial Inserts are substantially equivalent to predicate Optetrak Logic tibial inserts cleared per 510(k)s K093360, K110547, K111400, K121307. K123342, K933610, and K932776.

Page 2 of 2 Section 8

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

October 11, 2013

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

Re: K132161

Trade/Device Name: Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts 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: September 19, 2013 Received: September 20, 2013

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

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Page 2 - Mr. Patrick Hughes

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/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/ResourcesforYou/Industry/default.htm.

Sincercly yours.

Erin Keith

िर

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® 17mm & 19mm Thick Inserts Special 510(k) - Indications for Use

510(k) Number: K132161

Device Name: Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts

INDICATIONS

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

Prescription Use_ ど (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 Section 7

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.