(125 days)
Not Found
No
The document describes a mechanical knee replacement system and its components, with no mention of AI or ML in its intended use, device description, or performance studies.
Yes.
The device is a knee replacement system designed to alleviate severe pain and disability caused by various forms of arthritis and other conditions, which are therapeutic functions.
No
This device, the GMK Total Knee System, is a knee replacement system designed for implantation in total knee arthroplasty, not for diagnosing conditions. Its intended use is to treat existing severe pain and/or disability due to various forms of arthritis or other joint degeneration, not to identify them.
No
The device description explicitly lists physical components made from Co-Cr-Mo, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total knee arthroplasty, addressing conditions like arthritis and avascular necrosis. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device components are described as implants made from Co-Cr-Mo, designed to be surgically placed in the knee joint.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
· Avascular necrosis of femoral condyle.
· Post traumatic loss of joint configuration.
· Primary implantation failure.
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
In case a GMK Revision tibial tray is used, an extension stem must be implanted.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The GMK Extension is a line extension to the Medacta GMK Total Knee System and consists of the following components which are all made from Co-Cr-Mo (ISO 5832-4):
- . Femur STD cemented #0, Left and Right
- . Femur PS cemented #0, Left and Right
- Femur STD cemented #1 and #7 Narrow, Left and Right .
- . Femur PS cemented #1 and #7 Narrow, Left and Right
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modification to the device system to include the addition of the GMK Extension was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA quidance, and comparison to the predicate device svstem. The GMK Extension was compared to the worst case predicate device in terms of mechanical strength, range of motion, constraints to prevent risk of dislocation, and contact pressures/wear and it was determined that the GMK Extension is not worst case.
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.
K081023, K090988, K120790, K121416, K122232, K140826
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing right, with flowing lines connecting them.
December 2, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medacta International Mr. Adam Gross Director of Regulatory, Quality and Compliance 1556 West Carroll Avenue Chicago, Illinois 60607
Re: K142069
Trade/Device Name: GMK Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 1, 2014 Received: October 2, 2014
Dear Mr. Gross:
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
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/Resourcesfor You/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
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Indications for Use
510(k) Number (if known) K142069
Device Name GMK Total Knee System
Indications for Use (Describe)
The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
· Avascular necrosis of femoral condyle.
· Post traumatic loss of joint configuration.
· Primary implantation failure.
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
In case a GMK Revision tibial tray is used, an extension stem must be implanted.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/1 description: The image shows the logo for Medacta International. The logo features two blue triangles pointing upwards, followed by the word "Medacta" in blue. Below the word is a yellow line, and below that is the word "International" in a smaller font. To the right of the word "International" is a small red and white Swiss flag.
510(k) Summary
Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
- Contact Person: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: (805) 910-6511 Fax: (805) 437-7553 Email: AGross@medacta.us.com
July 30, 2014 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: GMK Total Knee System Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. 21 CFR 888.3560 Class II Product Code(s): JWH
Predicate Device(s):
| 510(k) | Product | 510(k) Holder | Clearance
Date |
|---------|--------------------------|-----------------------|-------------------|
| K081023 | Evolis Total Knee System | Medacta International | 10/22/2008 |
| K090988 | GMK Total Knee System | Medacta International | 7/10/2009 |
| K120790 | GMK Femur Size 7 | Medacta International | 6/8/2012 |
| K121416 | GMK Sphere | Medacta International | 7/30/2012 |
| K122232 | GMK Narrow | Medacta International | 9/28/2012 |
| K140826 | GMK Sphere Extension | Medacta International | 7/15/2014 |
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Product Description
The GMK Extension is a line extension to the Medacta GMK Total Knee System and consists of the following components which are all made from Co-Cr-Mo (ISO 5832-4):
- . Femur STD cemented #0, Left and Right
- . Femur PS cemented #0, Left and Right
- Femur STD cemented #1 and #7 Narrow, Left and Right .
- . Femur PS cemented #1 and #7 Narrow, Left and Right
Indications for Use
The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
- · Avascular necrosis of femoral condyle.
- Post traumatic loss of joint configuration.
- · Primary implantation failure.
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cvlinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
In case a GMK Revision tibial tray is used, an extension stem must be implanted.
Comparison to Predicate Devices
The indications for use, design features and materials of the GMK Extension are substantially equivalent to those of the predicate devices. The substantial equivalence of the GMK Extension implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.
Performance Testing
The modification to the device system to include the addition of the GMK Extension was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA quidance, and comparison to the predicate device svstem. The GMK Extension was compared to the worst case predicate device in terms of mechanical strength, range of motion, constraints to prevent risk of dislocation, and
6
contact pressures/wear and it was determined that the GMK Extension is not worst case.
Conclusion:
Based on the above information, the GMK Extension can be considered as substantially equivalent to its predicate devices.