(57 days)
Not Found
No
The summary describes a mechanical knee prosthesis system and does not mention any AI or ML components.
Yes
The device is a knee replacement system used to treat conditions like osteoarthritis and rheumatoid arthritis, which are considered therapeutic interventions.
No
The device is a knee prosthesis system used in total knee replacement surgery, not for diagnosing conditions. Its primary function is to replace damaged knee components.
No
The device description explicitly states it is a "cemented total knee prosthesis system that provides femoral components, tibial inserts, stems, augments, and surgical instrumentation," which are all hardware components.
Based on the provided information, the Exactech® Optetrak Logic® CC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for total knee replacement surgery in skeletally mature individuals. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a total knee prosthesis system consisting of implants (femoral components, tibial inserts, stems, augments) and surgical instrumentation. These are physical devices implanted or used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Optetrak Logic CC does not involve the analysis of such specimens.
Therefore, the Exactech® Optetrak Logic® CC is a surgical implant/prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Exactech® Optetrak Logic® CC 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.
The Exactech® Optetrak Logic® CC is indicated for cemented use only.
Product codes
JWH
Device Description
Optetrak Logic CC is a cemented total knee prosthesis system that provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty. Like corresponding predicate Optetrak CC system femoral components and tibial inserts, Optetrak Logic CC femoral components and tibial inserts are constrained condylar prostheses featuring an increased level of constraint compared to other Optetrak and Optetrak Logic knee system devices. Optetrak Logic CC also provides various stem extensions and augment blocks surgeons can use to address bone defects and bone loss.
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
This submission includes references to the following mechanical testing:
- Constraint testing
- Stem extension fatigue testing.
Key Metrics
Not Found
Predicate Device(s)
K954208, K093360, K933610, K012251
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of three stylized human profiles facing right, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2015
Exactech, Inc. Patrick Hughes Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K150890 Trade/Device Name: Exactech® Optetrak Logic® CC 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: March 30. 2015 Received: April 2, 2015
Dear Patrick 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
1
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 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" (21 CFR 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 Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150890
Device Name Exactech® Optetrak Logic® CC
Indications for Use (Describe)
The Exactech® Optetrak Logic® CC 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.
The Exactech® Optetrak Logic® CC is indicated for cemented use only.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Exactech® Optetrak Logic® CC Traditional 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
| ---------- | ----------------------------------------------------------------- |
|---|
Phone: (352) 377-1140 (352) 378-2617 Fax:
FDA Establishment Number 1038671
- Contact: Patrick Hughes Senior Regulatory Affairs Specialist
- Date: March 30, 2015
Trade or Proprietary or Model Name(s):
Exactech® Optetrak Logic® CC
Common Name:
Cemented Total Knee Prosthesis
Classification Name:
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K954208 | Optetrak CC | Exactech, Inc |
| K093360 | Optetrak Logic | Exactech, Inc |
| K933610 | Optetrak Trapezoidal Trays | Exactech, Inc. |
| K012251 | Optetrak Stem Extensions | Exactech, Inc |
Indications for Use:
The Optetrak Logic CC 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.
The Optetrak Logic CC Total Knee System is indicated for cemented use only.
4
Exactech® Optetrak Logic® CC Traditional 510(k) - 510(k) Summary of Safety and Effectiveness
Device Description:
Optetrak Logic CC is a cemented total knee prosthesis system that provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty. Like corresponding predicate Optetrak CC system femoral components and tibial inserts, Optetrak Logic CC femoral components and tibial inserts are constrained condylar prostheses featuring an increased level of constraint compared to other Optetrak and Optetrak Logic knee system devices. Optetrak Logic CC also provides various stem extensions and augment blocks surgeons can use to address bone defects and bone loss.
Testing Description:
This submission includes references to the following mechanical testing:
- Constraint testing
- Stem extension fatigue testing .
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CC Total Knee System devices are substantially equivalent to cited cleared predicate Optetrak devices.