(21 days)
Not Found
No
The document describes a mechanical knee prosthesis and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a knee prosthesis, which is designed to replace a damaged knee joint to alleviate pain and restore function, directly treating a medical condition.
No
This device is a knee prosthesis, which is an implant used for total knee arthroplasty, not a tool for diagnosing conditions.
No
The device description clearly describes physical components (knee prosthesis, liners, stems, wedges) and their mechanical function in total knee arthroplasty. There is no mention of software as the primary or sole component.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a knee prosthesis, which is an implantable medical device used to replace a damaged knee joint. Its intended use is for total knee arthroplasty (knee replacement surgery).
- Lack of Diagnostic Function: The device does not perform any tests on bodily samples to diagnose a condition or provide information about a patient's health status based on those tests. It is a physical replacement for a joint.
Therefore, based on the provided information, the Evolis®/GMK® knee prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Evolis®/GMK® knee prosthesis 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 augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
Product codes
JWH
Device Description
This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision Hybrid Liners. The GMK® Revision Hybrid Liners work with tibial baseplates from the GMK® Total Knee System, femoral components from the Evolis Total Knee System, and an extension stem, offset connector, and tibial wedges from the GMK® Total Knee System -Revision, which are optional for patient specific cases. The GMK Revision Hybrid Liners provide the surgeon with an additional option. The GMK® Revision Hybrid Liners are offered as both Ultracongruent (UC) Fixed and Posterior Stabilized (PS) Fixed in six sizes with five thicknesses from 10 mm to 20 mm. The GMK® Revision Hybrid Liners are attached to the GMK® tibial baseplates of the same size from the GMK® Total Knee System and articulate with the existing Evolis femoral component. The device is used primarily during an Evolis Revision surgery where the Evolis tibial baseplate is revised with a GMK tibial baseplate and the existing Evolis femoral component stays intact. The GMK Revision Hybrid Liners can also be used if a surgeon desires to couple a GMK tibial baseplate with an Evolis femoral component during a primary surgery. GMK Revision ultracongruent hybrid liners can be used only with standard Evolis femoral components and fixed GMK tibial baseplates. GMK Revision posterior-stabilized hybrid liners can be used only with posterior-stabilized Evolis femoral components and fixed GMK tibial baseplates.
The GMK® Revision Hybrid Liners are made of Ultra High Molecular Weight Polyethylene (UHMWPE), the same material and processing, as is used in the GMK® Total Knee System's standard, ultracongruent (UC), and posteriorstabilized (PS) tibial inserts and patellas. Like the GMK® Total Knee System's PS tibial inserts, the GMK® Hybrid PS Liners are attached to the GMK® fixed bearing tibial baseplates, cleared in the original GMK® Total Knee System. They are attached with a fixing screw, which is identical to the GMK® PS tibial inserts.
The GMK® Revision Hybrid Liners are offered in thicknesses from 10 to 20mm and in sizes 1 - 6, the same as all of the GMK® Total Knee System components. The GMK® Revision Hybrid Liners only work with the same size GMK® tibial baseplate, similar to how the previously cleared tibial inserts work. The GMK Revision Hybrid Liners may be used with either a left or right GMK® tibial baseplate in the same manner as the previously cleared tibial inserts. The GMK® Revision Hybrid Liners, when attached to the GMK® tibial baseplates, allow the use of extension stems, offset connectors, and tibial wedges as optional augments, identical to the other previously cleared tibial inserts. On the femoral side, the GMK® Revision Hybrid Liners only work with the same size Evolis femoral component. GMK Revision ultracongruent hybrid liners can be used only with standard Evolis femoral components and fixed GMK tibial baseplates. GMK Revision posterior-stabilized hybrid liners can be used only with posterior-stabilized Evolis femoral components and fixed GMK tibial baseplates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (femoral condyle)
Indicated Patient Age Range
Not Found
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)
The modification to the GMK® Total Knee system to include the addition of the GMK® Revision Hybrid Liners 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 pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device systems. The testing was conducted on the worst case component size and option/design based on engineering analysis. The performance testing conducted on the GMK® Revision Hybrid Liners was very similar to the protocols conducted for the predicate device, the GMK® Total Knee System. The testing included range of motion and mobility of the articulating surfaces, comparative wear behavior, and a measure of the clipping system endurance. The testing met all acceptance criteria and verifies that the performance of the GMK® Revision Hybrid Liners is substantially equivalent to the predicate device systems.
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
K III 283 (1/3)
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two black triangles, the word "Medacta" in black letters, a horizontal line underneath the word, and the word "International" in smaller black letters below the line. To the right of the word "International" is a symbol that looks like a plus sign.
MAY 2 7 2011
510(k) Summary
Manufacturer: 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: Mr. Adam Gross RA/QA Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7089 Email: AGross@medacta.us.com
Date Prepared: May 6, 2011
DEVICE INFORMATION
Trade/Proprietary Name: GMK® Total Knee System - GMK Revision Hybrid Liners Common Name: Total Knee Prosthesis - Tibial Inserts Classification Name: Knee joint patellofemorotibial metal/polymer/metal semiconstrained cemented prosthesis
Classification: Class II, 21 CFR 888.3560 Product Code: JWH Predicate Device: K090988 GMK® Total Knee System (Medacta International), cleared July 10, 2009
1
IIIZ83 (213)
Product Description
This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision Hybrid Liners. The GMK® Revision Hybrid Liners work with tibial baseplates from the GMK® Total Knee System, femoral components from the Evolis Total Knee System, and an extension stem, offset connector, and tibial wedges from the GMK® Total Knee System -Revision, which are optional for patient specific cases. The GMK Revision Hybrid Liners provide the surgeon with an additional option. The GMK® Revision Hybrid Liners are offered as both Ultracongruent (UC) Fixed and Posterior Stabilized (PS) Fixed in six sizes with five thicknesses from 10 mm to 20 mm. The GMK® Revision Hybrid Liners are attached to the GMK® tibial baseplates of the same size from the GMK® Total Knee System and articulate with the existing Evolis femoral component. The device is used primarily during an Evolis Revision surgery where the Evolis tibial baseplate is revised with a GMK tibial baseplate and the existing Evolis femoral component stays intact. The GMK Revision Hybrid Liners can also be used if a surgeon desires to couple a GMK tibial baseplate with an Evolis femoral component during a primary surgery. GMK Revision ultracongruent hybrid liners can be used only with standard Evolis femoral components and fixed GMK tibial baseplates. GMK Revision posterior-stabilized hybrid liners can be used only with posterior-stabilized Evolis femoral components and fixed GMK tibial baseplates.
Indications for Use
The Evolis®/GMK® knee prosthesis 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 augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
Comparison to Predicate Devices
The GMK® Total Knee System was cleared under K090988. GMK® Revision components, as a line extension, was cleared under a Special 510(k), K102437. Evolis Total Knee System was cleared under K081023 and was the main predicate for the
GMK Revision Hybrid Liners 510(k) May 27, 2011
Section 5 - Page 3 of 4
2
GMK Total Knee System. The subject of this submission is the GMK® Revision Hybrid Liners, an additional line extension of the GMK Total Knee System.
The indications for use for the modified system remain the same as the GMK Revision 510(k), K102437.
The GMK® Revision Hybrid Liners are made of Ultra High Molecular Weight Polyethylene (UHMWPE), the same material and processing, as is used in the GMK® Total Knee System's standard, ultracongruent (UC), and posteriorstabilized (PS) tibial inserts and patellas. Like the GMK® Total Knee System's PS tibial inserts, the GMK® Hybrid PS Liners are attached to the GMK® fixed bearing tibial baseplates, cleared in the original GMK® Total Knee System. They are attached with a fixing screw, which is identical to the GMK® PS tibial inserts.
The GMK® Revision Hybrid Liners are offered in thicknesses from 10 to 20mm and in sizes 1 - 6, the same as all of the GMK® Total Knee System components. The GMK® Revision Hybrid Liners only work with the same size GMK® tibial baseplate, similar to how the previously cleared tibial inserts work. The GMK Revision Hybrid Liners may be used with either a left or right GMK® tibial baseplate in the same manner as the previously cleared tibial inserts. The GMK® Revision Hybrid Liners, when attached to the GMK® tibial baseplates, allow the use of extension stems, offset connectors, and tibial wedges as optional augments, identical to the other previously cleared tibial inserts. On the femoral side, the GMK® Revision Hybrid Liners only work with the same size Evolis femoral component. GMK Revision ultracongruent hybrid liners can be used only with standard Evolis femoral components and fixed GMK tibial baseplates. GMK Revision posterior-stabilized hybrid liners can be used only with posterior-stabilized Evolis femoral components and fixed GMK tibial baseplates.
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act.
The modification to the GMK® Total Knee system to include the addition of the GMK® Revision Hybrid Liners 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 pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device systems. The testing was conducted on the worst case component size and option/design based on engineering analysis. The performance testing conducted on the GMK® Revision Hybrid Liners was very similar to the protocols conducted for the predicate device, the GMK® Total Knee System. The testing included range of motion and mobility of the articulating surfaces, comparative wear behavior, and a measure of the clipping system endurance. The testing met all acceptance criteria and verifies that the performance of the GMK® Revision Hybrid Liners is substantially equivalent to the predicate device systems.
Conclusion:
Based on the above information, the GMK Revision Hybrid Liners can be considered as substantially equivalent to its predicate devices.
GMK Revision Hybrid Liners 510(k) May 27, 2011
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medacta International SA % Medacta USA Mr. Adam Gross RA/QA 4725 Calle Quetzal, Unit B Camarillo, California 93012
MAY 2 7 2011
Re: K111283
Trade/Device Name: GMK® Total Knee System - GMK Revision Hybrid Liners 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: May 6, 2011 Received: May 6, 2011
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
4
Page 2 - Mr. Adam Gross
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/AboutiFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ervin L. Keith
Jur Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111283
Device Name: GMK® Total Knee System - GMK Revision Hybrid Liners
Indications for Use:
The Evolis®/GMK® knee prosthesis 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 condvle.
- Post traumatic loss of joint configuration.
- · Primary implantation failure.
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
Prescription Use × (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Kitt
Sign-Oil) Division Division of Surgical, Orthopedic, and Restorative Devices
GMK Revision Hybrid Liners 510(k) 510(k) Number - 111283 May 27, 2011
Section 4 - Page 2 of 2