K Number
K153595
Device Name
Optetrak Logic Metaphyseal Cones
Manufacturer
Date Cleared
2016-03-25

(100 days)

Product Code
Regulation Number
888.3560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optetrak Logic Metaphyseal Cones 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. The augments are intended for press-fit fixation with the proximal tibial or distal femur. The final implant construct is completed by cementing a tibial tray or femoral component in place.
Device Description
Optetrak Logic Metaphyseal Cones are designed to fill tibial and femoral bone voids during revision or complex primary surgery in the case of severe bone loss. Specifically, Optetrak Logic Metaphyseal Cones are designed to enhance fixation in primary or revision total knee arthroplasty (TKA) patients who have Anderson Orthopaedic Research Institute (AORI) type II and III tibial and femoral defects by providing stability to total knee implants via the metaphysis.
More Information

No
The summary describes a mechanical implant (metaphyseal cones) for knee replacement surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The testing described is focused on the physical properties and performance of the implant.

No.
The device is an orthopedic implant (metaphyseal cones) used for bone void filling and enhancing fixation in total knee replacement surgery, not a therapeutic device for treating a condition outside of a surgical implant context.

No
The device, Optetrak Logic Metaphyseal Cones, is an implant used for total knee replacement surgery to fill bone voids and enhance fixation. Its function is to modify bone structure, not to diagnose a condition.

No

The device description clearly indicates it is a physical implant (metaphyseal cones) designed to fill bone voids during knee replacement surgery. The performance studies listed are related to the mechanical properties and biocompatibility of a physical device, not software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description: The provided text clearly describes a physical implant (metaphyseal cones) designed to be surgically placed within the body to address bone loss during knee replacement surgery.
  • Intended Use: The intended use is for surgical implantation to enhance fixation of knee implants, not for analyzing biological specimens.

The device is a surgical implant, not a diagnostic tool used outside the body.

N/A

Intended Use / Indications for Use

The Optetrak Logic Metaphyseal Cones 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.

The augments are intended for press-fit fixation with the proximal tibial or distal femur. The final implant construct is completed by cementing a tibial tray or femoral component in place.

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

JWH

Device Description

Optetrak Logic Metaphyseal Cones are designed to fill tibial and femoral bone voids during revision or complex primary surgery in the case of severe bone loss. Specifically, Optetrak Logic Metaphyseal Cones are designed to enhance fixation in primary or revision total knee arthroplasty (TKA) patients who have Anderson Orthopaedic Research Institute (AORI) type II and III tibial and femoral defects by providing stability to total knee implants via the metaphysis.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee, Tibial, Femoral

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)

This submission includes or references the following non-clinical testing:

  • Fatigue testing
  • Mating analysis
  • Cadaveric implantation and surgeon assessment
  • Biocompatibility assessment
  • Compressive plastic deformation testing
  • Abrasion resistance
  • Static tensile strength testing
  • Shear resistance
  • Porous structure characterization

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.

K143393

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.

K102975

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

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.

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

March 25, 2016

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

Re: K153595

Trade/Device Name: Optetrak Logic Metaphyseal Cones 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: February 24, 2016 Received: February 26, 2016

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

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/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 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,

Mark N. Melkerson -S

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

Enclosure

2

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K153595 - Page 1 of 2 Exactech® Optetrak Logic® Metaphyseal Cones Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

| Sponsor: | Exactech, Inc.
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 |
| Date: | March 25, 2016 |

Trade of Proprietary or Model Name(s):

Exactech® Optetrak Logic® Metaphyseal Cones

Common Name:

Knee System Augments

Classification Name:

Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (CFR 888. 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:

Acetabular Shell, Cluster-Hole

510(k) NumberTrade or Proprietary Model NameManufacturer
K143393Triathlon® Tritanium® Cone AugmentsStryker
Reference devices:
510(k) NumberTrade or Proprietary Model NameManufacturer
K102975Novation® Crown Cup® With InteGrip™Exactech, Inc.

4

K153595 - Page 2 of 2 Exactech® Optetrak Logic® Metaphyseal Cones Traditional 510(k) - 510(k) Summary of Safety and Effectiveness

Indications for Use:

The Optetrak Logic Metaphyseal Cones 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.

The augments are intended for press-fit fixation with the proximal tibial or distal femur. The final implant construct is completed by cementing a tibial tray or femoral component in place.

Device Description:

Optetrak Logic Metaphyseal Cones are designed to fill tibial and femoral bone voids during revision or complex primary surgery in the case of severe bone loss. Specifically, Optetrak Logic Metaphyseal Cones are designed to enhance fixation in primary or revision total knee arthroplasty (TKA) patients who have Anderson Orthopaedic Research Institute (AORI) type II and III tibial and femoral defects by providing stability to total knee implants via the metaphysis.

Testing:

This submission includes or references the following non-clinical testing:

  • Fatigue testing ●
  • Mating analysis
  • Cadaveric implantation and surgeon assessment ●
  • Biocompatibility assessment
  • Compressive plastic deformation testing
  • Abrasion resistance ●
  • Static tensile strength testing ●
  • Shear resistance .
  • Porous structure characterization

Substantial Equivalence Conclusion:

A comparison of key features and attributes included in this submission demonstrates the proposed Optetrak Logic Metaphyseal Cones devices are substantially equivalent to predicate Triathlon Tritanium Cone Augments, legally marketed per 510(k) submission K143393.