(174 days)
Not Found
No
The summary describes a knee implant and its indications for use, focusing on material properties and surgical application. There is no mention of AI, ML, image processing, or any computational analysis typically associated with AI/ML in medical devices.
Yes
The device is indicated for use in total knee replacement surgery due to various degenerative conditions, which is a therapeutic procedure aimed at restoring function and relieving pain in the knee joint.
No
Explanation: This device is an implantable knee component for total knee replacement surgery. Its purpose is to replace or revise a failed knee reconstruction, not to diagnose a condition.
No
The device description explicitly states it is a "Femoral Component," which is a physical implant used in knee replacement surgery, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "primary surgery for total knee replacement" and "revision of failed previous reconstructions." This describes a surgical implant used in vivo (within the body) to replace a joint.
- Device Description: The description refers to "Femoral Components," which are parts of a knee implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The testing described (porosity, chemical composition) is related to the physical properties of the implant material, not diagnostic analysis of biological samples.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an orthopedic implant used in vivo.
N/A
Intended Use / Indications for Use
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.
Product codes
MBH, JWH
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
1
K140302
Exactech® Optetrak Logic® Porous Femoral Component Traditional 510(k) - 510(k) Summary of Safety and Effectiveness
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.
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.
2
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.
3
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
4
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
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.
| 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
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