· Severely painful and/or disabled joint as a result of arthritis, theumatoid arthritis or polyarthritis.
· Post traumatic loss of joint configuration.
· Considerable loss of function of the knee joint.
· High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
· Primary implantation failure.
· Former revision arthroplasty.

Device Description

The 3DMetal Tibial Cones are implantable devices to be used as fillers in cases of severe bone deficiency. The subject devices are to be cemented to the GMK Revision and GMK Hinge systems' tibial trays. The subject devices have a full-density layer that prevents cement occluding the pores of the external layer.

The purpose of this submission is to gain clearance for the tibial cones available in centred and eccentric versions. The tibial cones are available in sizes XS, S, M, and L with heights of 20 mm and 25 mm.

The subject devices are intended to be used with the cleared indications for use and the tibial trays of Medacta's GMK Revision (K102437) and GMK Hinge (K130299) systems.

The 3DMetal Tibial Cones are manufactured with titanium alloy substrate, which is identical to predicate devices Regenerex Porous Titanium Sleeve Augments (K072336). However the subject devices' material is processed using electron beam melting (EBM) similar to the material of referenced device Delta TT Acetabular System (K141395).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "3DMetal Tibial Cones." The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval application (PMA).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with specific numerical targets and reported device performance. Instead, it states that "testing was conducted to written protocols with acceptance criteria that were based on standards and FDA guidance documents." The performance data is described qualitatively, referencing compliance with various ASTM standards.

However, based on the performance data section, we can infer the types of tests conducted and their implied acceptance criteria (compliance with standards).

Acceptance Criteria (Implied)	Reported Device Performance
Dynamic Fatigue: Compliance with ASTM F1800-12 (Cyclic Fatigue Testing Of Metal Tibial Tray Components)	Testing conducted to written protocols, acceptance criteria based on standards. (Implied: Device passed these tests)
Shear Testing: Compliance with ASTM F1044-05 (Shear Testing of Calcium Phosphate Coatings and Metallic Coatings)	Testing conducted to written protocols, acceptance criteria based on standards. (Implied: Device passed these tests)
Shear Fatigue Testing: Compliance with ASTM F1160-14 (Shear and Bending Fatigue Testing of Coatings)	Testing conducted to written protocols, acceptance criteria based on standards. (Implied: Device passed these tests)
Tensile Testing: Compliance with ASTM F1147-05 (Tension Testing of Calcium Phosphate and Metal Coatings)	Testing conducted to written protocols, acceptance criteria based on standards. (Implied: Device passed these tests)
Stereological Evaluation: Compliance with ASTM F1854-09 (Stereological Evaluation Of Porous Coatings)	Testing conducted to written protocols, acceptance criteria based on standards. (Implied: Device passed these tests)
Pyrogenicity: Compliance with European Pharmacopoeia §2.6.14 (Bacterial Endotoxin Test) and USP chapter <151> (Pyrogen Test)	Testing conducted using both methods. Medacta has no intentions of labeling the subject devices as non-pyrogenic or pyrogen free. (Implied: Testing was performed, and results were
consistent with the intended use/lack of non-pyrogenic claim)
Biocompatibility: Permanent implant >30 days (Equivalency determined)	Biocompatibility testing conducted on predicate and reference devices for the same material supports subject device's biological safety.
Material Composition: Compliance with ISO 5832-3:1996 and ASTM F2924-12a	Subject devices' material (titanium alloy) is processed using electron beam melting (EBM) similar to referenced devices and meets these standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for any of the non-clinical mechanical or pyrogenicity tests. It simply states that "testing was conducted to written protocols."

The data provenance is from non-clinical laboratory testing performed by the manufacturer, Medacta International SA. There is no mention of country of origin for the data beyond the manufacturer's location (Switzerland), and the studies are inherently prospective as they were conducted to support this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This submission focuses on the substantial equivalence of a physical medical device (tibial cones) for knee replacement, based on mechanical testing and material properties, not on diagnostic performance or interpretation by experts. Therefore, there is no "ground truth" in the traditional sense established by experts for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As there is no ground truth requiring expert consensus or interpretation, no adjudication method was used.

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:

Not applicable. This submission is for an implantable medical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established scientific and engineering standards and principles demonstrated through laboratory testing. The device is evaluated against:

Mechanical performance standards: ASTM F1800-12, ASTM F1044-05, ASTM F1160-14, ASTM F1147-05, ASTM F1854-09.
Biocompatibility standards: Implied by comparison to predicate devices and general standards for implantable materials.
Material composition standards: ISO 5832-3:1996, ASTM F2924-12a.
Pyrogenicity standards: European Pharmacopoeia §2.6.14, USP chapter <151>.

Essentially, the ground truth is the device's ability to consistently meet these recognized safety and performance benchmarks.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The device's design and manufacturing processes are based on established engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/machine learning model, this question is not relevant.

Summary

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

Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, with flowing lines that suggest movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2017

Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi Usa. Inc 2343 Alexandria Drive Suite 100 Lexington, Kentucky 40504

Re: K170149 Trade/Device Name: 3DMetal Tibial Cones 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: July 3, 2017 Received: July 3, 2017

Dear Elizabeth Rose:

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

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

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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

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.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K170149

Device Name 3DMetal Tibial Cones

Indications for Use (Describe)

The 3DMetal Tibial Cones are indicated for use with the GMK Hinge knee systems, as well as the GMK tibial extension stems and offsets.

Specific indications are as follows:

· Severely painful and/or disabled joint as a result of arthritis, theumatoid arthritis or polyarthritis.
· Post traumatic loss of joint configuration.
· Considerable loss of function of the knee joint.
· High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
· Primary implantation failure.
· Former revision arthroplasty.

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.

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."

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

3.0 510(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 Affairs Manager Date Prepared: January 13, 2017 Date Revised: July 3, 2017

II. Device

Device Proprietary Name:	3DMetal Tibial Cones
Common or Usual Name:	Total Knee Prosthesis
Classification Name:	Knee joint, patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
Regulation Number:	21 CFR 888.3560
Product Code:	JWH
Device Classification	2

III. Predicate Device

Substantial equivalence is claimed to the following devices: Primary Predicate:

Trabecular Metal Tibial Cone Augments, K102896, Zimmer Trabecular Metal o Technology
Regenerex Porous Titanium Sleeve Augments, K072336, Biomet Manufacturing Corp. ●

Reference Predicate

GMK Total Knee System (also referred to as GMK Primary), K090988, Medacta ● International SA
GMK Total Knee System-Revision (also referred to as GMK Revision), K102437, ● Medacta International SA
GMK Hinge, K130299, Medacta International SA ●
Delta TT Acetabular System, K141395, Limacorporate S.p.A. ●

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

IV. Device Description

The subject devices are intended to be used with the cleared indications for use and the tibial trays of Medacta's GMK Revision (K102437) and GMK Hinge (K130299) systems.

V. Indications for Use

The 3DMetal Tibial Cones are indicated for use with the GMK Revision and GMK Hinge knee systems, as well as the GMK tibial extension stems and offsets.

Specific indications are as follows:

o Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
Post traumatic loss of joint configuration.
Considerable loss of function of the knee joint. ●
o High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
o Primary implantation failure.
o Former revision arthroplasty.

VI. Comparison of Technological Characteristics

The 3DMetal Tibial Cones and the predicate devices share the following characteristics:

Indications for Use ●
Materials
Packaging
Design ●
Use with tibial trays ●
Sterile
Sizes ●

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

The 3DMetal Tibial Cones are technologically different from the predicate devices as follows:

Heights available
o Manufacturing Process

Biocompatibility testing conducted on the predicate and reference devices for the same material, supports the biological safety of the 3DMetal Tibial Cones. Additional biocompatibility testing was deemed unnecessary because the materials and manufacturing process are identical to the predicate devices described below and meet ISO 5832-3:1996 Implants For Surgery – Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy and ASTM F2924-12a Standard Specification For Additive Manufacturing Titanium-6 Vanadium With Powder Bed Fusion.

A comparison of the subject and predicate devices is provided in the table below.

Parameters	3DMetal TibialCones(Subject Device)	Trabecular MetalTibial ConeAugmentsK102896(Predicate Device)	Regenerex PorousTitanium SleeveAugmentsK072336(Predicate Device)
Design/Types	Cemented to cone oftibial tray; Centredand Eccentric	Cemented to cone oftibial tray; Full andStepped	Cemented to cone oftibial tray
Material	Titanium Alloy	Tantalum	Titanium Alloy
ManufacturingProcess	Electron BeamMelting	AdditiveManufacturing	Chemical VaporDeposition
Sizes	Sizes XS, S, M, L	Sizes XS, S, M, L	Sizes XS, S, M, L
Heights	20 mm, 25 mm	15 mm, 30 mm	25mm, 40mm
Compatibilitywith implantsystem	GMK Revision andGMK Hinge	NexGen CompleteKnee Solution,Legacy LCCK andRotating Hinge KneeSystems	Vanguard SSKRevision KneeSystem
Device usage	Single Use	Single Use	Single Use
Shelf Life	5 years	5 years	5 years
Biocompatibility	Implant withpermanent >30 day(Equivalencydetermined)	Implant withpermanent >30 day	Implant withpermanent >30 day
Sterilization	Gamma	Gamma	Gamma
Packaging	Individual packaging	Individual packaging	Individual packaging

Technological comparison

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

Discussion

As seen above, the differences between the subject and predicate devices are that the subject devices have different heights than the predicate devices. Although the subject devices and predicate devices are made of titanium alloy, the manufacturing process method is different because the subject devices use electron beam melting to process the titanium. This technological difference does not raise new questions of safety or effectiveness and a comparison evaluation shows there are no new risks associated with the subject devices design.

VII. Performance Data

Based on the risk analysis and pre-submission submitted to FDA to review testing protocols, testing was conducted to written protocols with acceptance criteria that were based on standards and FDA guidance documents. The following mechanical tests are being provided in support of a substantial equivalence determination:

Non-Clinical Studies

. Dynamic Fatigue Test: ASTM F1800-12 Standard Test Method For Cyclic Fatigue Testing Of Metal Tibial Tray Components Of Total Knee Joint Replacements
Characterization Test
- o Shear Testing: ASTM F1044-05 (Reapproved 2011) Standard Test Method For Shear Testing of Calcium Phosphate Coatings And Metallic Coatings
- Shear Fatigue Testing: ASTM F1160-14 Standard Test Method For Shear and о Bending Fatigue Testing of Calcium Phosphate And Metallic Medical And Composite Calcium Phosphate/Metallic Coatings
- Tensile Testing: ASTM F1147-05 (Reapproved 2011) Standard Test Method For o Tension Testing of Calcium Phosphate And Metal Coatings
- Stereological Evaluation: ASTM F1854-09 Standard Test Method For O Stereological Evaluation Of Porous Coatings On Medical Implants
Pyrogenicity ●
- o Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and the Pyrogen Test according to USP chapter <151> for pyrogenicity determination.
- Medacta has no intentions of labeling the subject devices as non-pyrogenic or o pyrogen free.

Clinical Studies

. No clinical studies were conducted.

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

VIII. Conclusion

The information provided above supports that the 3DMetal Tibial Cones are as safe and effective as the predicate devices. The subject devices are manufactured using the Electron Beam Melting (EBM) process in with titanium alloy, as compared to the predicate devices, does not raise any new questions of safety and effectiveness. Therefore, it is concluded that the 3DMetal Tibial Cones are substantially equivalent to the 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.