(71 days)
No
The summary describes a mechanical knee implant with design modifications for increased stability, and the performance studies focus on mechanical constraint testing. There is no mention of AI/ML terms, image processing, or data sets for training/testing algorithms.
Yes
The device is a total knee replacement system, which is a common therapeutic intervention to alleviate pain and restore function in individuals with severe knee conditions.
No
This device is a total knee replacement system used for surgical implantation, not for diagnosing conditions. Its purpose is to replace a diseased or damaged knee joint.
No
The device description clearly states it is a physical implant (tibial insert) made from materials using manufacturing processes, and performance studies involve physical testing (ASTM F1223-08) and cadaver labs.
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 details a "Tibial Insert" which is a component of a knee replacement system. This is a physical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant, which falls under a different regulatory category.
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 System is indicated for cemented use only.
Product codes
JWH
Device Description
The proposed Optetrak Logic CRC Tibial Insert devices represent modifications to existing Optetrak Logic CR Knee System components cleared per 510(k) K111400 and 510(k) K121307. 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.. Compared to predicate Logic CR inserts; the proposed Logic CRC inserts are designed to provide additional stability in the absence of a fully functioning PCL.
The proposed and predicate devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- Both made from ultra high molecular weight polyethylene per ASTM F648
- Both have the same indications for use
- Both have similar design features
- Both have the same shelf life
- Both are compatible with the same Logic devices
- Both 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
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)
Testing based on the methods detailed in ASTM F1223-08 was performed to characterize the amount of constraint introduced by the proposed dimensional changes (n=5). Compared to predicate Logic CR inserts, the results showed average Logic CRC anterior constraint increased 54%, average posterior constraint increased 14%, and average overall anterior-posterior constraint increased 34%. Average Logic CRC medial-lateral constraint increased 6% versus the predicate Logic CR devices, and average Logic CRC rotational constraint increased 33% over Logic CR. Devices were also evaluated by surgeon experts during cadaver lab testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Exactech® Optetrak Logic® CRC Tibial Insert Special 510(k) - 510(k) Summary of Safety and Effectiveness
- 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: October 29, 2012
Trade or Proprietary or Model Name(s):
Exactech® Optetrak Logic® CRC Tibial Insert
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 or Model Name | Manufacturer |
|---|---|---|
| K111400 | Optetrak Logic CR Knee System | Exactech, Inc |
| K121307 | Optetrak Logic CR Knee System Sizes 0 and 6 | Exactech, Inc |
JAN 1 0 2013
1
Exactech® Optetrak Logic® CRC Tibial Insert Special 510(k) - 510(k) Summary of Safety and Effectiveness
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 System is indicated for cemented use only.
Device Description:
The proposed Optetrak Logic CRC Tibial Insert devices represent modifications to existing Optetrak Logic CR Knee System components cleared per 510(k) K111400 and 510(k) K121307. 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.. Compared to predicate Logic CR inserts; the proposed Logic CRC inserts are designed to provide additional stability in the absence of a fully functioning PCL.
The proposed and predicate devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- � Both made from ultra high molecular weight polyethylene per ASTM F648
- . Both have the same indications for use
- . Both have similar design features
- . Both have the same shelf life
- . Both are compatible with the same Logic devices
- Both are packaged and sterilized using the same materials and processes .
Summary of Testing
Testing based on the methods detailed in ASTM F1223-08 was performed to characterize the amount of constraint introduced by the proposed dimensional changes (n=5). Compared to predicate Logic CR inserts, the results showed average Logic CRC anterior constraint increased 54%, average posterior constraint increased 14%, and average overall anterior-posterior constraint increased 34%. Average Logic CRC medial-lateral constraint increased 6% versus the predicate Logic CR devices, and average Logic CRC rotational constraint increased 33% over Logic CR. Devices were also evaluated by surgeon experts during cadaver lab testing.
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic CRC Tibial Insert devices are substantially equivalent to cleared predicate Optetrak Logic cruciate-retaining tibial insert devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing another person, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: January 10, 2013
Exactech, Incorporated % Mr. Patrick Hughes Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K123342
Trade/Device Name: Exactech® Optetrak Logic® CRC Tibial Insert 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: December 10, 2012 Received: December 11, 2012
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
3
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/CDRH/CDRHOffices/ucm]15809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech® Optetrak Logic® CRC Tibial Insert Special 510(k) - Indications for Use
K123342 510(k) Number:
Device Name: Exactech® Optetrak Logic® CRC Tibial Insert
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 System is indicated for cemented use only.
X Prescription Use _ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
2013.01.10 13:19:20
Please do not write below this line - use another page if needed.
and/or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices -- 05'00'