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.

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

AI/ML Overview

This document is a 510(k) premarket notification for the "GMK Total Knee System," specifically concerning a line extension called "GMK Extension." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided, attempting to fill in the requested details:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated as specific numerical criteria in the provided text. The criteria are broadly described as "predefined acceptance criteria" based on standards, FDA guidance, and comparison to predicate devices for mechanical strength, range of motion, constraints, and contact pressures/wear.	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." The submission concludes that the GMK Extension is "substantially equivalent" to its predicate devices.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The document mentions "performance testing" but does not give specific numbers for physical samples or simulated cases used in the testing.
- Data provenance: Not specified. It's generally inferred that the testing would have been conducted by Medacta International or a contracted lab, likely in Switzerland (where Medacta is headquartered as per the contact information) or the USA. The type of study is a design verification physical/mechanical testing, not human clinical trial data (retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is largely not applicable to the type of study described. This 510(k) summary focuses on mechanical performance testing of a knee implant, not an AI or diagnostic device that requires expert-established ground truth from images or clinical data. The "ground truth" here is the physical/mechanical performance of the device against established engineering standards and predicate device performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, this pertains to clinical/diagnostic studies where human review or consensus is used for ground truth. The testing mentioned is engineering/mechanical.
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:
- No. This is not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is based on pre-defined acceptance criteria derived from industry standards, FDA guidance, and mechanical performance benchmarks established by the predicate devices. This is a form of engineering performance ground truth, not clinical ground truth.
The sample size for the training set:
- Not applicable. This device is a mechanical implant, not an AI system that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As this is not an AI device, there is no training set and no ground truth establishment for a training set.

Summary

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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

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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	ClearanceDate
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

• 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

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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.

Regulation Number and Section

§ 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.