(30 days)
Not Found
No
The summary describes a knee replacement system with dimensional modifications and mechanical testing, with no mention of AI or ML.
Yes
The device is a total knee replacement system, which is used to treat medical conditions like osteoarthritis and rheumatoid arthritis, indicating a therapeutic purpose.
No
The device is a knee replacement system used in surgery, not for diagnosing conditions.
No
The device description clearly states it involves dimensional modifications to physical components (tibial inserts, tibial trays), and the performance studies involve mechanical testing, indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a knee replacement system intended for surgical implantation in skeletally mature individuals undergoing total knee replacement. This is a surgical implant, not a device used for testing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVDs, such as:
- Testing of biological samples
- Detection of biomarkers, diseases, or conditions through laboratory analysis
- Use in a laboratory setting
Therefore, based on the provided information, the OPTETRAK Comprehensive Knee Systems and OPTETRAK Logic CC Total Knee System are surgical implants and not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Optetrak Logic Total Knee System:
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious 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.
Optetrak Logic CC Total Knee System:
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, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.
The OPTETRAK Logic CC Total Knee System is indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
This submission proposes dimensional modifications to features common to all Optetrak Logic tibial inserts, Optetrak Logic trapezoidal tibial trays, and Optetrak Logic Combo tibial trays. These modifications are designed to enhance intraoperative assembly.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission includes references to the following mechanical testing:
- . Micromotion testing
- Shear testing
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, K111400, K121307, K110547, K123342, K132161, K150890, K101981
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
§ 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 the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K152170
Trade/Device Name: Exactech Optetrak Logic Enhanced Assembly Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 31, 2015 Received: August 4, 2015
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 of medical device-related
1
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
510(k) Number (if known) K152170
Device Name Exactech Optetrak Logic Enhanced Assembly
Indications for Use (Describe)
Optetrak Logic Total Knee System:
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious 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.
Optetrak Logic CC Total Knee System:
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, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.
The OPTETRAK Logic CC Total Knee System 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) |
|---|---|
| ---------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------- |
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Exactech® Optetrak Logic® Enhanced Assembly Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
|----------|-----------------------------------------------------------------|
| Phone: | (352) 377-1140 |
| Fax: | (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Contact: | Patrick Hughes
Senior Regulatory Affairs Specialist |
| Date: | July 31, 2015 |
Trade or Proprietary or Model Name(s):
Exactech® Optetrak Logic® Total Knee System & Exactech® Optetrak Logic® CC Total Knee System
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 |
|---|---|---|
| K093360 | Optetrak Logic PS | |
| K111400 | Optetrak Logic CR, Sizes 1-5 | |
| K121307 | Optetrak Logic CR, Sizes 0 & 6 | |
| K110547 | Optetrak Logic PSC | Exactech, Inc |
| K123342 | Optetrak Logic CRC | |
| K132161 | Optetrak Logic 17mm & 19mm Tibial Inserts | |
| K150890 | Optetrak Logic CC | |
| K101981 | Optetrak Logic Combo Trays |
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,
4
Exactech® Optetrak Logic® Enhanced Assembly Special 510(k) - 510(k) Summary of Safety and Effectiveness
except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless 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.
Device Description:
This submission proposes dimensional modifications to features common to all Optetrak Logic tibial inserts, Optetrak Logic trapezoidal tibial trays, and Optetrak Logic Combo tibial trays. These modifications are designed to enhance intraoperative assembly.
Testing Description:
This submission includes references to the following mechanical testing:
- . Micromotion testing
- Shear testing
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic and Optetrak Logic CC devices are substantially equivalent to cited cleared predicate Optetrak Logic devices.