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, traumatoid arthritis, rheumatoid arthritis.
Avascular necrosis of femoral condyle.
· Post traumatic loss of joint configuration.
· Primary implantation failure.

GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.

· Collagen disorders, and/or avascular necrosis of the femoral condyle.
· Moderate valgus, varus, or flexion deformities.
Cemented tibial wedges 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 the case of a semi-constrained liner is being used, an extension stem must be implanted both on the femoral components. In the case a GMK Revision tibial tray is being used, an extension stem must be implanted.

Device Description

The GMK Total Knee System - TiNbN Coating is a line extension to the GMK Total Knee System to provide a larger product offering. The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures where there is evidence of sufficient sound bone to seat and support for the implants. GMK Total Knee System - TiNbN Coating includes the following implants:

o GMK Femoral Component, Standard and Posterior Stabilized, Left and Right, Sizes from 0 to 7
. GMK Femoral Component Narrow, Standard and Posterior Stabilized, Left and Right, Sizes from 1 to 7
GMK-Sphere Femoral Component, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ . (intermediate sizes)
0 Tibial tray fixed cemented. Left and Right, Sizes from 1 to 6 plus 4 intermediate sizes.

The GMK Total Knee System - TiNbN Coating implants, both Femoral Components and Tibial Tray, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery - Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Nitride (TiNbN) coating. The GMK Total Knee System -TiNbN Coating: Fixed Tibial Tray Plug is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.

AI/ML Overview

This document is a 510(k) premarket notification for the "GMK Total Knee System - TiNbN Coating." It is a submission to the FDA for a medical device, which is typically a hardware product. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, the device is a knee replacement system (GMK Total Knee System - TiNbN Coating). The information in the document does not relate to an AI/ML powered device, nor does it describe studies with acceptance criteria relevant to AI/ML device performance or human reader improvements with AI assistance. It focuses on the physical and material properties, and biological safety of a traditional medical implant.

Therefore, many of the requested categories for AI/ML device performance are not applicable or cannot be answered from the provided text.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

Since this is a physical medical device (knee implant) and not an AI/ML powered one, the acceptance criteria are based on mechanical properties, biological safety, and design equivalence rather than algorithmic performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria (from implied tests)	Reported Device Performance
Performance Testing:
Modular Tapered Connection Evaluation	Passed Medacta Test Protocol IL 07.09.517 rev.0 and Medacta Test Report A.2, and Endolab Test Report 167.181121.20.87 Rev.0
Wear Test (3 Mode)	Passed Medacta Test Protocol IL 07.09.513 Rev. 2 and Medacta O Test Report A.3 and Element Test Reports 00812-010290-1 and 00812-010290-3
Coating Characterization	Performed according to ISO 11885
Mechanical resistance of femoral component under physiological static and dynamic loads	Previously conducted on predicate devices (K090988, K120790, K121416, K12232, K140826, K142069) and reviewed.
Mechanical resistance of tibial tray under physiological static and dynamic loads	Previously conducted on predicate devices (K090988, K120790, K121416, K12232, K140826, K142069) and reviewed.
Connection of tibial tray with tibial insert	Previously conducted on predicate devices (K090988, K120790, K121416, K12232, K140826, K142069) and reviewed.
Pyrogenicity:
Bacterial Endotoxin Test (LAL test)	Conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>)
Pyrogen test	Conducted according to USP chapter <151>
Biocompatibility:
Assessment and testing	Performed as per ISO 10993 series and FDA Biocompatibility Guidance document.

The study proving the device meets the acceptance criteria is the series of non-clinical performance tests listed above, as well as pyrogenicity and biocompatibility assessments. These studies demonstrate that the TiNbN coated components perform equivalently to the uncoated predicate device and meet relevant safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text mentions "testing was conducted according to written protocols" for the performance, pyrogenicity, and biocompatibility assessments. It refers to specific test reports and standards (e.g., Medacta Test Report A.2, Element Test Reports 00812-010290-1 and 00812-010290-3). These tests are typically performed on a limited number of device samples in a laboratory setting, not on patient data or clinical populations.

Sample Size: Not explicitly stated for each test, but implied to be a representative number of physical device components for mechanical, wear, and material testing.
Data Provenance: The tests are explicitly referred to as "Non-Clinical Studies" and are laboratory-based. The companies involved (Medacta, Endolab, Element) might indicate the origin of the testing facilities, but specific "country of origin of data" in the sense of patient data is not applicable. The studies are prospective in the sense that the tests were specifically designed and performed to validate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. For a physical device like a knee implant, "ground truth" is established by direct measurement of physical properties (e.g., strength, wear, material composition) using validated scientific methods and instruments, not by expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are used for interpreting clinical or imaging data, especially for AI/ML devices, to establish a consensus ground truth. For mechanical and biological testing of a physical implant, the "truth" is determined by the results of the laboratory tests against predefined specifications.

5. 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 a physical knee implant, not an imaging device or an AI/ML system that assists human readers. Therefore, an MRMC study is not relevant and was not conducted. The document explicitly states: "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical knee implant. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on:

Standardized Test Results: Compliance with established international standards (e.g., ISO 5832-4, ISO 5834-2, ISO 11885, ISO 10993 series) and specific internal test protocols for mechanical properties (wear, strength of connections, resistance under loads).
Material Characterization: Verification of material composition and coating properties.
Biological Safety Standards: Adherence to established standards for biocompatibility and pyrogenicity (e.g., European Pharmacopoeia, USP chapters).

8. The sample size for the training set

This question is not applicable. There is no "training set" for a physical medical device. The design and manufacturing process for the implant is based on established engineering principles and prior knowledge.

9. How the ground truth for the training set was established

This question is not applicable. There is no training set as this is not an AI/ML device.

Summary

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December 11, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K202684

Trade/Device Name: GMK Total Knee System - TiNbN Coating Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 15, 2020 Received: September 15, 2020

Dear Chris Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K202684

Device Name GMK Total Knee System - TiNbN Coating

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, traumatoid arthritis, rheumatoid arthritis.
Avascular necrosis of femoral condyle.
· Post traumatic loss of joint configuration.
· Primary implantation failure.

GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.

· Collagen disorders, and/or avascular necrosis of the femoral condyle.
· Moderate valgus, varus, or flexion deformities.
Cemented tibial wedges 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.

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)

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510(k) Summary

I. Submitter

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: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: September 11, 2020

II. Device

Device Proprietary Name:	GMK Total Knee System - TiNbN Coating
Common or Usual Name:	Total Knee Prosthesis
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Primary Product Code:	JWH
Regulation Number:	21 CFR 888.3560
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

GMK Total Knee System, K090988, Medacta International SA ●
GMK-Line Extension, K120790, Medacta International SA (also referred to as the GMK Total Knee System)
GMK Sphere, K121416, Medacta International SA (also referred to as the GMK Total Knee System)
GMK Narrow, K122232, Medacta International SA (also referred to as the GMK Total Knee System)
GMK Sphere Extensions, K140826, Medacta International SA (also referred to as the ● GMK Total Knee System)
GMK Extension, K142069, Medacta International SA (also referred to as the GMK Total Knee System)
LINK® Endo-Model® Knee System with PorEx® (TiNbN) Coating, K152431, Waldemar 0 Link GmbH & Company KG

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Device Description IV.

o GMK Femoral Component, Standard and Posterior Stabilized, Left and Right, Sizes from 0 to 7
. GMK Femoral Component Narrow, Standard and Posterior Stabilized, Left and Right, Sizes from 1 to 7
GMK-Sphere Femoral Component, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ . (intermediate sizes)
0 Tibial tray fixed cemented. Left and Right, Sizes from 1 to 6 plus 4 intermediate sizes.

V. 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:

o 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. ●

GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, 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.
Collagen disorders, and/or avascular necrosis of the femoral condyle. .
Moderate valgus, varus, or flexion deformities. 0

Cemented tibial wedges 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 the case of a semi-constrained liner is being used, an extension stem must be implanted both on the tibial and on the femoral components. In the case a GMK Revision tibial tray is being used, an extension stem must be implanted.

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VI. Comparison of Technological Characteristics

The GMK Total Knee System - TiNbN Coating and the predicate devices GMK Total Knee System (K090988, K120790, K121416, K122232, K140826, K142069) share the following characteristics:

indication for use
design: ●
fixation
substrate material; ●
device usage;
sterility: ●
shelf life; and ●
o packaging.

The GMK Total Knee System - TiNbN Coating differs from the predicate devices GMK Total Knee System (K090988, K120790, K121416, K122232, K140826, K142069) in relation to the coating only as the subject devices have a TiNbN coating while the predicate devices have no coating.

Performance Data VII.

Based on the risk analysis, testing was conducted according to written protocols. The following tests are being provided in support of a substantial equivalence determination:

Non-Clinical Studies:

PERFORMANCE TESTING
- o Evaluation of modular tapered connection according to Medacta Test Protocol IL 07.09.517 rev.0 and Medacta Test Report A.2, and Endolab Test Report 167.181121.20.87 Rev.0
- Wear test 3 Mode according to Medacta Test Protocol IL 07.09.513 Rev. 2 and Medacta O Test Report A.3 and Element Test Reports 00812-010290-1 and 00812-010290-3
- Coating characterization according to ISO 11885 O
- The following performance tests were previously conducted on the predicate devices O and reviewed as part of the GMK Total Knee System submissions K090988. K120790. K121416, K12232, K140826 and K142069:
  - . mechanical resistance of the femoral component under physiological static and dynamic loads:
  - mechanical resistance of the tibial tray under physiological static and dynamic loads:
  - connection of the tibial tray with the tibial insert.

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Medacta International SA

PYROGENICITY ●

Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
Pyrogen test according to USP chapter <151> for pyrogenicity determination O
The subject devices are not labeled as non-pyrogenic or pyrogen free O
0 BIOCOMPATIBILITY
- Biocompatibility assessment and related testing as per ISO 10993 series and FDA O Biocompatibility Guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Clinical Studies

No clinical studies were conducted ●

VIII. Conclusion

Based on the above information, the GMK Total Knee System - TiNbN Coating implants can be considered substantially equivalent to the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The GMK Total Knee System -TiNbN Coating implants are as safe and effective as the predicate devices, GMK Total Knee System (K090988, K120790, K121416, K122232, K140826, K142069).

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.