The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

The GMK 3D Metal® Tibial Baseplate is indicated for cemented application 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, rheumatoid arthritis or polyarthritis
· Collagen disorders, and avascular necrosis of the 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 or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseplate.

Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment

GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

· Severely painful and/or disabled joint as a result of arthritis, rheumatic arthritis or polyarthritis
· Collagen disorders, and/or avascular necrosis of the femoral condyle
· Moderate valgus, varus, or flexion deformities

Device Description

The GMK 3D Metal Tibial Tray is a line extension to Medacta GMK Total Knee System.

The subject devices are sterile, individually packaged implants designed for cemented use in Total Knee Arthroplasty procedures.

The GMK 3D Metal Tibial Tray is available in eleven sizes plus two bridge versions with right and left configuration.

The subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically a knee replacement component. The provided text outlines the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain a study that proves the device meets specific acceptance criteria in the way an AI/ML device submission would.

The document states: "No clinical studies were conducted." and focuses on non-clinical performance data for the mechanical properties and biocompatibility of the implant. Therefore, I cannot provide the requested information regarding acceptance criteria and studies in the context of AI/ML device performance.

Here's why the prompt's request for acceptance criteria and a study to prove device performance (as would be applicable to an AI/ML device) cannot be fully answered from this document:

No AI/ML Component: The GMK 3D Metal Tibial Tray is a physical implant (a knee prosthesis component). It is not an AI/ML-powered diagnostic, prognostic, or treatment guidance device.
Performance Metrics Differ: The performance data provided is related to the material properties and mechanical integrity of the implant (e.g., stereological evaluation, tension tests, shear tests, fatigue tests, cementation studies, biocompatibility, shelf-life, pyrogenicity). These are not metrics like sensitivity, specificity, AUC, or reader performance improvement, which would be relevant for AI/ML devices.
No Ground Truth or Human Expert Review: Since it's a physical implant, there's no "ground truth" derived from expert consensus or pathology in the AI/ML sense, nor a need for human experts to interpret AI output. The "ground truth" for an implant is its mechanical integrity, biocompatibility, and intended function within the body.

Therefore, for this specific submission, the categories requested (e.g., sample size for test set, number of experts, adjudication, MRMC study, standalone performance, ground truth type for test/training sets) are not relevant or applicable, as they pertain to the evaluation of AI/ML algorithms.

If this were an AI/ML device submission, the acceptance criteria would typically involve performance metrics related to its intended use (e.g., accuracy for image interpretation, specificity, sensitivity). The "study" would be a clinical or retrospective validation study comparing the device's output to a ground truth established by experts or pathology.

Summary of what can be extracted related to "performance" for this physical device:

The "acceptance criteria" and "study" are implicit in the Non-Clinical Studies section, demonstrating that the device meets engineering and safety standards for an orthopedic implant.

Table of Acceptance Criteria and Reported Device Performance: This document does not provide a formal table of "acceptance criteria" against "reported device performance" in the format typically seen for AI/ML devices with specific metrics like sensitivity or specificity. Instead, the submission relies on demonstrating compliance with ASTM standards and biocompatibility evaluations. The "performance" is the fact that the device passed these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ASTM F1854-15 (Stereological evaluation)	Studied/Evaluated
Compliance with ASTM F1147-05(2017)e1 (Tension test)	Studied/Evaluated
Compliance with ASTM F1044-05(2017)e1 (Static shear test)	Studied/Evaluated
Compliance with ASTM F1160-14(2017)e1 (Dynamic shear test)	Studied/Evaluated
Compliance with ASTM F1978-18 (Taber abrasion resistance test)	Studied/Evaluated
Cementation study (implied mechanical stability with cement)	Studied/Evaluated
Compliance with ASTM F1800-19e1 (Dynamic endurance fatigue test)	Studied/Evaluated
Compliance with European Pharmacopoeia §2.6.14/USP <85> (LAL)	Studied/Evaluated
Compliance with USP <151> (Pyrogen test)	Studied/Evaluated
Biocompatibility	Evaluated
Shelf-life	Evaluated

Note: "Studied/Evaluated" implies the device met the requirements of these tests, as the submission states this data supports substantial equivalence.

Sample size used for the test set and data provenance: Not applicable in the AI/ML sense. Test "samples" would be physical devices or materials undergoing mechanical and biological testing. There is no "data set" of patient images or records. The provenance is from Medacta International S.A. internal testing.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for an implant is established by engineering standards and biological safety assessments, not expert consensus on interpretations.
Adjudication method for the test set: Not applicable.
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, as this is not an AI/ML device. "No clinical studies were conducted."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
The type of ground truth used: Material properties, mechanical integrity, biocompatibility, and absence of pyrogens per established ASTM and Pharmacopoeia standards.
The sample size for the training set: Not applicable. This refers to the training of an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

August 23, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health and Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".

Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K221850

Trade/Device Name: GMK 3D Metal Tibial Tray Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH. JWH Dated: June 24, 2022 Received: June 27, 2022

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

{1}------------------------------------------------

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,

For: 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221850

Device Name GMK 3D Metal Tibial Tray

Indications for Use (Describe)

The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

The GMK 3D Metal® Tibial Baseplate is indicated for cemented application 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, rheumatoid arthritis or polyarthritis
· Collagen disorders, and avascular necrosis of the femoral condyle
· Post traumatic loss of joint configuration
Primary implantation failure

It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseplate.

Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment

GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

· Severely painful and/or disabled joint as a result of arthritis, rheumatic arthritis or polyarthritis
· Collagen disorders, and/or avascular necrosis of the femoral condyle
· Moderate valgus, varus, or flexion deformities

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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, Senior Director Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: June 24, 2022 Date Revised: August 23, 2022

II. Device

Device Proprietary Name:	GMK 3D Metal Tibial Tray
Common or Usual Name:	Total Knee Joint Replacement
Classification Name:	Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis
Primary Product Code	MBH
Secondary Product Code:	JWH
Regulation Number:	21 CFR 888.3565, 21 CFR 888.3560
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device:

Triathlon Tritanium Tibia Baseplate, Stryker, K123486
Additional predicate devices:
GMK Total Knee System, K090988, Medacta International SA
GMK Sphere, K121416, Medacta International SA
GMK Spherika Femurs and Fixed Tibial Trays Plus, K211004, Medacta International SA
A Triathlon Total Knee System, K201343, Howmedica Osteonics Corp. dba Stryker Orthopaedics

Reference device:

Mpact 3D Metal DMLS, K202568, Medacta International SA

{5}------------------------------------------------

Device Description IV.

The GMK 3D Metal Tibial Tray is a line extension to Medacta GMK Total Knee System.

The subject devices are sterile, individually packaged implants designed for cemented use in Total Knee Arthroplasty procedures.

The GMK 3D Metal Tibial Tray is available in eleven sizes plus two bridge versions with right and left configuration.

The subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.

V. Indications for Use

The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

The GMK 3D Metal® Tibial Baseplate is indicated for cemented application 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
Collagen disorders, and avascular necrosis of the 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 semiconstrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

It is not possible to implant tibial wedges and extens with the GMK 3D Metal® Tibial Baseblate.

Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment

GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

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

{6}------------------------------------------------

VI. Comparison of Technological Characteristics

The subject devices are substantially equivalent to the predicate. Triathlon Tritanium Tibia Baseplate (K123486), with regards to the following characteristics:

Primary stability;
Materials: ●
Biocompatibility; ●
Device usage: ●
Packaging; ●
Shelf-life; and .
Sterilization.

The subject implants differ from the predicate device, Triathlon Tibia Baseplate (K123486) as follows:

o Design:
Sizes:
Secondary stability. ●

Discussion

Medacta International SA has not made any change to the materials, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.

Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the GMK 3D Metal Tibial Tray to the identified predicate devices.

VII. Performance Data

Based on the risk analysis, design validation and performance testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:

Non-Clinical Studies

DESIGN VALIDATION ●
- 3D Metal Tibia Tray Anthropometric Study O
- Design Validation wetlab o
PERFORMANCE TESTING ●
- Stereological evaluation according to ASTM F1854-15 o
- Tension test on 3D metal honeycomb trabecular structure according to ASTM F1147 o 05(2017)e1
- Static shear test on 3D metal honeycomb trabecular structure according to ASTM F1044 o 05(2017)e1

{7}------------------------------------------------

Dynamic shear test on 3D metal honeycomb trabecular structure according to ASTM F1160o 14(2017)e1
Taber abrasion resistance test on 3D metal honeycomb trabecular structure according to O ASTM F1978-18
GMK 3D Metal Tibial Tray cementation study o
GMK 3D Metal Tibial Tray Dynamic endurance fatigue test according to ASTM F1800-19e1 o
PYROGENICITY ●
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is о equivalent to USP chapter <85>)
- Pyrogen test according to USP chapter <151> for pyrogenicity determination o
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
BIOCOMPATIBILITY evaluation ●
SHELF-LIFE evaluation

Clinical Studies:

No clinical studies were conducted. ●

VIII. Conclusion

The information provided above supports that the GMK 3D Metal Tibial Tray are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.