K Number

Device Name

OPTERTRAK LOGIC PSC TIBIAL INSERT

Manufacturer

EXACTECH SARASOTA

Date Cleared

2011-04-14

(48 days)

Product Code

JWH

Regulation Number

888.3560

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 Description

The proposed Optetrak Logic PSC Tibial Insert devices represent modifications to existing Optetrak Logic Total Knee System components (K093360). Both proposed and predicate devices are made from the same materials using the same processes and are compatible with the same Optetrak Logic tibial trays and femoral components. The proposed Logic PSC devices combine the articulating geometry and locking features of predicate Optetrak Logic posterior stabilized inserts with a central spine that is slightly thicker in the medial/lateral dimensions, intended to provide surgeons with an option for treating patients with minor ligament laxity by introducing 2°-3° more varus/valgus constraint than the predicate. The proposed and predicate devices have the same intended use and basic fundamental scientific technology and share the following similarities: - . the same indications for use - . similar design features - . the same shelf life - are packaged and sterilized using the same materials and processes. .

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K093360

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical implant (tibial insert) with design modifications for increased constraint. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes

The device is indicated for use in conjunction with total knee replacement surgery to address conditions such as osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.

Diagnostic

This device is a total knee replacement system, which is a prosthetic used to treat conditions like osteoarthritis. It is an implantable device, not a diagnostic tool.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical component (tibial insert) of a total knee replacement system, made from materials and processes, and is subject to engineering studies related to physical properties like shear strength and constraint. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The provided text describes a surgical implant used for total knee replacement. It is a physical component inserted into the body during surgery.
Intended Use: The intended use is to replace a damaged knee joint due to various conditions. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.

The information provided clearly indicates this is a medical device used in vivo (within the body) for treatment, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

JWH

Device Description

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

skeletally mature individuals

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Evaluation	Activities Performed
Logic PSC tibial spine shear strength	Review of predicate designs for clinical performance and resistance to shear forces Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance
Logic PSC/mating femoral component compatibility	Cadaver laboratory assessment Review of predicate designs for clinical performance Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC varus/valgus constraint	Cadaver laboratory assessment Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC internal/external constraint	Cadaver laboratory assessment Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC tibial spine/mating femoral component clearance	Review of predicate designs for clinical performance Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic PSC Tibial Insert devices are substantially equivalent to cleared predicate Optetrak Logic posterior stabilized tibial insert devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K093360

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

KI10547

Exactech® Optetrak® Logic™ PSC Tibial Insert Special 510(k) - 510(k) Summary of Safety and Effectiveness

APR 1 4 2011

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 Regulatory Affairs Specialist
Date: April 8, 2011

Trade or Proprietary or Model Name(s):

Exactech® Optetrak® Logic™ PSC Tibial Insert

Common Name:

Cemented Total Knee Prosthesis

Classification Name:

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

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

Information on devices to which substantial equivalence is claimed:

	510(k) Number	Trade or Proprietary or Model Name	Manufacturer
	K093360	Optetrak Logic Total Knee System	Exactech, Inc

Exactech® Optetrak® Logic™ PSC Tibial Insert 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:

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

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

Exactech® Optetrak® Logic™ PSC Tibial Insert Special 510(k) - 510(k) Summary of Safety and Effectiveness

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 PSC tibial spine shear strength	Review of predicate designs for clinical performance and resistance to shear forces Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance
Logic PSC/mating femoral component compatibility	Cadaver laboratory assessment Review of predicate designs for clinical performance Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC varus/valgus constraint	Cadaver laboratory assessment Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC internal/external constraint	Cadaver laboratory assessment Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC tibial spine/mating femoral component clearance	Review of predicate designs for clinical performance Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance

Table 1: Optetrak Logic PSC Tibial Insert Performance Data

Substantial Equivalence Conclusion:

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

Exactech, Inc. % Mr. Patrick Hughes Regulatory Affairs Specialist 2320 N.W. 66" Court Gainesville, Florida 32653

APR 1 4 2011

Re: K110547

Trade/Device Name: Exactech Optetrak Logic PSC Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 23, 2011 Received: March 24, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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.

Sincerely, yours,

for

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

Enclosure

Exactech® Optetrak® Logic™ PSC Tibial Insert Special 510(k) - Indications for Use

510(k) Number:

KI10547

Device Name: Exactech® Optetrak® Logic™ PSC Tibial Insert

INDICATIONS

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)

for M. Mielkeom

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Divisionomative Devices

510(k) Number K110547