(234 days)
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 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.
The GMK Revision extension is comprised of tibial trays and tibial augments that can be used in either a Primary or Revision surgery. The only difference between the tibial trays and the tibial trays of the predicate device (K090988) is the addition of four threaded screw holes in the bottom surface to allow the connection with the tibial augments. The tibial trays are equivalent to the predicate device (K090988) in terms of material, sizes, general design features and manufacturing process. The tibial trays are offered in six sizes (1 thru 6) in left and right configuration and are made of Cobalt-Chromium-Molybdenum alloy according to ISO 5832-4:1996. The tibial augments are offered in the same seven different sizes (0 thru 6), and 5mm or 10mm thicknesses as the predicate device (K102437) and have a similar shape. They are made of High Nitrogen Stainless Steel M30NW ISO 5832-9. The tibial augments are secured to the tibial trays with either 5mm or 10mm screws made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3:1996.
The provided document describes the 510(k) premarket notification for the "GMK Revision extension" Total Knee Prosthesis. It discusses the device's design, indications for use, and comparison to predicate devices, focusing on the changes and how its safety and effectiveness are supported.
However, this document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of device performance as typically understood for AI/ML or diagnostic devices (e.g., sensitivity, specificity, accuracy).
Instead, the "Performance Testing" section describes mechanical testing conducted for substantial equivalence. It refers to:
- Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| "pre-defined acceptance criteria" based on standards, FDA guidance, and comparison to the predicate device system for mechanical performance. Implicitly, these criteria would ensure the device can "withstand expected in vivo loading without failure" and be "equivalent to devices currently cleared for use." | The GMK Revision extension was subjected to testing according to ASTM F1800 - 07 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements. This analysis determined that the GMK Revision extension is not worst case compared to the predicate devices. A review of the mechanical data indicates that the GMK Revision extension is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure. |
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Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing of physical components, not a clinical study on human data. The "test set" would be the specific physical components (worst-case configuration) tested.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered design specifications, material properties, and relevant ASTM standards, not expert clinical consensus.
-
Adjudication method for the test set: Not applicable. Mechanical testing follows established protocols and measurements.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a knee prosthesis, not an AI/ML-enabled diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a knee prosthesis.
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The type of ground truth used: For mechanical testing, the "ground truth" is defined by the ASTM F1800-07 standard, engineering design specifications, and performance of predicate devices.
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The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical fatigue testing of a physical device. Design and engineering principles guide the device's creation.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided text details a regulatory submission for a knee prosthesis focused on mechanical performance and substantial equivalence to existing predicate devices, rather than a study involving human data or AI/ML algorithm performance. The "acceptance criteria" and "study" described are confined to the physical, mechanical properties of the implant component.
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JUL 2 6 2013
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
- Mr. Adam Gross Contact Person: Director of Requlatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com
Date Prepared: November 20, 2012
DEVICE INFORMATION
Trade/Proprietary Name: GMK Revision extension Common Name: Total Knee Prosthesis Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/Metal/Polymer
21 CFR 888.3560 Class II Device Product Codes: JWH
Predicate Devices: K090988 GMK Total Knee System (Medacta International) K102437 GMK Total Knee System - Revision (Medacta International) K120790 GMK Line Extension (Medacta International)
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Section 5 - 1 - 2 - 2 - 4:
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Product Description
The GMK Revision extension is comprised of tibial trays and tibial augments that can be used in either a Primary or Revision surgery. TThe only difference between the tibial trays and the tibial trays of the predicate device (K090988) is the addition of four threaded screw holes in the bottom surface to allow the connection with the tibial augments. The tibial trays are equivalent to the predicate device (K090988) in terms of material, sizes, general design features and manufacturing process. The tibial travs are offered in six sizes (1 thru 6) in left and right configuration and are made of Cobalt-Chromium-Molybdenum alloy according to ISO 5832-4:1996. The tibial augments are offered in the same seven different sizes (0 thru 6), and 5mm or 10mm thicknesses as the predicate device (K102437) and have a similar shape. They are made of High Nitrogen Stainless Stee! M30NW ISO 5832-9. The tibial augments are secured to the tibial trays with either 5mm or 10mm screws made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3:1996.
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 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.
Comparison to Predicate Devices
The indications for use of the GMK Revision extension are similar to the previously cleared predicate devices. The only difference is that the tibial wedges (augments) from the predicate device (K102437) must be cemented to the tibial baseplate whereas the
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K123721
tibial augments that are the subject of this submission are screwed to the tibial baseplate. Also, it is specified that an extension stem must be used with the tibial trays that are the subject of this submission. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the GMK Revision extension are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. The only difference between the tibial trays and the tibial trays of the predicate device (K090988) is the addition of four threaded screw holes in the bottom surface to allow the connection with the tibial augments. The difference between the tibial augments and the tibial augments of the predicate device (K102437) is the material, High Nitrogen Stainless Steel M30NW ISO 5832-9, as compared to Ti6-Al4-V ISO 5832-3:1996 for the predicate device (K102437). In addition, the 5mm or 10mm screws made of Ti6-Al4-V ISO 5832-3:1996 were not present in the predicate device (K102437). The final difference is that the tibial augments do not need to be cemented to the tibial tray as they use screws instead. However, both the tibial augments from this submission and the predicate device (K102437) use cement to secure the augments to the bone.
Performance Testing
Testing was performed according to ASTM F1800 - 07 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements analyzing the GMK Revision extension components to the worst case of the predicate devices. This analysis determined that the GMK Revision extension is not worst case compared to the predicate devices.
The modification to the GMK system to include the addition of the GMK Revision 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 pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards. FDA quidance, and comparison to the predicate device system. The testing was conducted on the worst case component size and option/design based on engineering analysis.
A review of the mechanical data indicates that the GMK Revision extension is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure.
Conclusion:
Based on the above information, the GMK Revision can be considered as substantially equivalent to its predicate devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2013
Medacta International SA % Medacta United States of America Mr. Adam Gross Director of Regulatory and Quality 4725 Calle Quetzal. Unit B Camarillo, California 93012
Re: K123721
Trade/Device Name: GMK Revision extension 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: June 24, 2013 Received: June 25, 2013
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
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Page 2 - Mr. Adam Gross
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdagov/MedicalDevices/ResourcesforYou/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/Safetv/ReportalProblem/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.
Sincercly yours.
Erin I. Keith
For
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): K123721
Device Name: GMK Revision extension
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 ioint 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.
Prescription Use × (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
GMK Revision extension 510(k) June 21, 2013
Section 4
§ 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.