The MOTO™ Lateral Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Device Description

MOTO™ Lateral Partial Knee System design is characterized by:

a femoral component designed to anatomically fit the lateral femoral condyle
a tibia component, designed to anatomically fit the lateral tibial condyle
a fixed tibia insert, with a flat articulating surface with rounded border

MOTO™ Lateral Partial Knee System has been designed in cemented version only. The femoral component is made of cobalt-chromium-molybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal baseplate component (Ti-6Al-4V per ISO 5832-3). The MOTO™ Lateral Partial Knee System implants are offered sterile (via gamma irradiation for the femoral and tibial tray components and ethylene oxide for the tibial insert components), are intended for single use only, and may not be re-sterilized

The Lateral Femoral Component (cemented) is symmetrically shaped (suitable for both left and right side) and designed with two (2) fixation pegs for all the sizes. It is available in seven (7) sizes (1 - 7).

The Lateral Fixed Tibial Insert has a fixed design, is symmetrically shaped (suitable for both left and right side) and is available in eight (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm). It is fixed through a snapping mechanism with baseplate.

The Lateral Fixed Tibial Tray (cemented) has a fixed bearing design with one (1) triangular keel and two (2) 'mushroom' shaped pegs to ensure primary stability. Available in eight (8) sizes (1 - 8), the Lateral Fixed Tibial Tray is offered in both Right Lateral (RL) and Left Lateral (LL) options for each size.

AI/ML Overview

This document is a 510(k) Premarket Notification for the MOTO™ Lateral Partial Knee System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of AI/ML device performance. Therefore, most of the requested information regarding AI/ML device performance is not applicable or available in this document.

However, I can extract the information related to the device's performance testing and general acceptance criteria as presented in the document.

Acceptance Criteria and Device Performance for Mechanical Testing:

The document states: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, the specific quantitative acceptance criteria and the numerical reported device performance are not explicitly detailed in the summary tables provided. Instead, the document lists the types of tests performed.

Acceptance Criteria Category (Implied by Test Type)	Reported Device Performance (Implied by Study Conclusion)
Design Validation (Cadaveric Workshop)	Successful validation (implied by "Design Validation Report")
Fatigue Endurance of Posterior Condyle	Met standards (implied by "Test Report A1, rev.0")
Comparative Coverage of Lateral Femoral Component	Met standards (implied by "Test Report A2, rev.0")
Mechanical Resistance of Lateral Tibial Tray	Demonstrated conservative design (implied by "Test Report B1, rev.0")
Comparative Coverage of Lateral Tibia Tray	Met standards (implied by "Test Report B2, rev.0")
Contact Area and Pressure (Conservative Design)	Demonstrated conservative design (implied by "Rationale C1, rev 0")
Insert-Tray Clipping System Static Shear and Draw	Met standards (implied by "Test Report C2 rev.0")
Range of Motion (Femoral Component - Tibia Insert)	Met standards (implied by "Test Report C3, rev.0")
Bacterial Endotoxin (Pyrogenicity)	Passed (implied by test according to European Pharmacopoeia §2.6.14)
Pyrogenicity (USP chapter <151>)	Passed (implied by test according to USP chapter <151>)

Detailed Information as per Request:

A table of acceptance criteria and the reported device performance:
- As noted above, specific numerical acceptance criteria and reported performance values are not explicitly stated in this 510(k) summary. The document mentions that "acceptance criteria... were based on standards" and lists the types of tests conducted. The conclusion of substantial equivalence implies that these criteria were met.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- For mechanical/non-clinical studies, sample sizes are not specified. The document mentions a "Cadaveric Workshop" for design validation, implying prospective testing on cadaveric specimens, but details on the number of specimens are absent.
- The document mentions "EndoLab Report IL test 167.180320.20.838 rev.0, dated 03.May.2018," which might contain sample size information in the full report, but it's not present in this summary.
- Data provenance (country of origin for test data) is not explicitly stated, though the manufacturer, Medacta International SA, is based in Switzerland, and test reports mention "EndoLab" (likely a testing lab).
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 as the document is for a medical device (knee system), not an AI/ML diagnostic or predictive device that would typically involve expert ground truth establishment for a test set. The validation involves mechanical and design testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of mechanical device submission. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human interpretation.
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 implant, not an AI-assisted diagnostic tool. No MRMC studies were performed or relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (knee implant), not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties of materials, and design specifications.
- Biocompatibility was supported by previous testing on predicate devices using similar materials.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing process involves engineering principles and material science, not machine learning training.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

January 30, 2019

Re: K183029

Trade/Device Name: MOTO™ Lateral Partial Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: October 24, 2018 Received: November 1, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2019.01.30 15:53:50 -05'00'

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)

K183029

Device Name MOTO Lateral Partial Knee System

Indications for Use (Describe)

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.

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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:

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"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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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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 Affairs Manager, Medacta International SA Date Prepared: October 24, 2018

II. Device

Device Proprietary Name:	MOTO™ Lateral Partial Knee System
Common or Usual Name:	Unicompartmental Knee prosthesis
Classification Name:	Knee joint femorotibial metal/polymer/ non-constrainedcemented prosthesis
Primary Product Code:	HSX
Regulation Number:	21 CFR 888.3520
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

JOURNEY Unicondylar Femoral Implant K073175, Smith & Nephew INC .; ●
JOURNEY Unicondylar Tibial Baseplates K102069, Smith & Nephew INC .; ●
ZIMMER Unicompartimental Knee System - K033363, Zimmer, INC .; and
MOTO™ Partial Knee System K162084, Medacta International SA. ●

IV. Device Description

MOTO™ Lateral Partial Knee System design is characterized by:

a femoral component designed to anatomically fit the lateral femoral condyle
a tibia component, designed to anatomically fit the lateral tibial condyle
a fixed tibia insert, with a flat articulating surface with rounded border

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V. Indications for Use

Discussion:

The Indications for Use Statement is identical to the predicate device MOTO™ Partial Knee System (K162084). It is also similar to the other predicate devices IFU: the only difference is that the subject device calls out the requirements for "evidence of sufficient sound bone to seat and support the components", and the predicate device cites specific example of degenerative joint disease ("osteoarthritis, traumatic arthritis, or avascular necrosis"). These differences do not create new intended uses for the subject device; the subject and predicate devices are all prostheses intended for use in knee arthroplasty.

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VI. Comparison of Technological Characteristics

The design features, and materials of the subject devices are substantially equivalent to those of the predicate devices. The tables below compare characteristics of the subject and predicate devices.

Feature	MOTO™ LateralPartial Knee System -Anatomical FemoralComponent	MOTO™ PartialKnee System -Anatomic FemoralComponent(K162084)	Smith & NephewJourney(K073175)	Zimmer UNI(K033363)
Sizes	7 sizes(Size 1 -7)	10 sizes(Size 1-10)	Same	7 sizes(Size A - G)
Configuration	LLRL	RM and LM	RM/LL and LM/RL	RM/LL andLM/RL
Material	CoCrMo - ISO 5832-4	Same	Same(with an oxiniumoxidized zirconiumcoating)	Same
Cemented?	Cemented	Same	Same	Same
Device Usage	Single Use	Same	Same	Same
Sterility	Provided sterile viaGamma Radiation	Same	Same	Same
Shelf Life	5 Years	Same	Same	> 5 Years
Stabilizationpegs	2 Pegs	2 pegs for sizes 1-7and 3 pegs forsizes 8-10	Same	Same

Feature	MOTO™ Lateral PartialKnee System - Fixed TibialInsert	MOTO™ Partial KneeSystem - Fixed TibialInsert (K162084)	Zimmer UNI(K033363)
Sizes	8 sizes (from 1 to 8)	Same	6 sizes (from 1 to 6)
Thickness	Each size is offered in 6levels of thickness (8, 9, 10,11. 12, 14 mm)	Same	Same
Material	UHMWPE (ISO 5834 -2)Type 1	Same	Same
Device Usage	Single Use	Same	Same
Sterility	Provided sterile via EthyleneOxide	Same	Same
Shelf Life	5 years	Same	> 5 years

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Medacta International SA

Feature	MOTO™ LateralPartial KneeSystem - FixedTibial Tray	MOTO™ PartialKnee System -Fixed Plus TibialTray (K162084)	Smith &NephewJourney(K102069)	Zimmer UNI(K033363)
Sizes	8 sizes(from 1 to 8)	Same	6 sizes	6 sizes(from 1 to 6)
Configurations	RL and LL	RM and LM	RM/LL andLM/RL	RM and LM
Material	Ti-6Al-4V(ISO 5832-3)	Same	Same	Ti-6Al-4V withPMMA precoat
Cemented?	Cemented	Same	Same	Same
Device Usage	Single Use	Same	Same	Same
Sterility	Provided sterile viaGamma Radiation	Same	Unknown	Same
Shelf Life	5 years	Same	Unknown	> 5 years
Stabilization	Stabilized with 1 keeland 2 pegs	Same	Same	Same
Fixed Bearing?	Fixed bearing	Same	Same	Same

The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Due to the extensive history of use in currently marketed medical devices, biocompatibility testing conducted on the predicate device [ MOTO™ Partial Knee System (K162084)] for the same materials supports the biological safety of the MOTO™ Lateral Partial Knee System.

VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in support of a substantial equivalence determination:

A Non-Clinical Studies: DESIGN VALIDATION
· Validation Cadaveric Workshop according to Instrument evaluation form dated 16-Dec-16
Design Validation Report

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CHARACTERIZATION TESTING

Fatigue Endurance Test of the Posterior Condyle according to Medacta Test Protocol . 07.09.455/Rev.0, Dated 09.Feb.2018 and EndoLab Report IL test 167.180320.20.838 rev.0, dated 03.May.2018. Test Report A1, rev.0
Comparative Coverage Test of the Moto Lateral Femoral Component. Test Report A2, ● rev.0
Rationale to Demonstrate Lateral Tibial Tray Conservative Design in Comparison with . the Medial Tibial Tray in Terms of Mechanical Resistance according to ASTM F1800:12 and ASTM F1814-97a. Test Report B1, rev.0.
Comparative Coverage Test of the Moto Lateral Tibia Tray. Test Report B2, rev.0. ●
o Rationale to Demonstrate Moto Lateral Conservative Design in Terms of Contact Area and Pressure in Comparison with the Medial Implant according to Test Reports C1 rev.0, C2 rev.0, C4 rev.0 already provided in the Original Submission MOTO™ Partial Knee System (K162084) and the Test Report D7 rev.0 already provided as per Additional Information request of that same submission.Rationale C1, rev 0.
Static ML/LM Shear and AP/PA Draw Test of the Insert-Tray Clipping System according to Guidance Document for Testing Non-Articulating, Mechanically Locked, Modular Implant Components; Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/ Polymer Porous-Coated Uncemented Prosthesis, Guidance for Industry and FDA; ASTM F2083:12; ASTM F1223:08; ASTM 1814:15. Test Report C2 rev.0.
. Lateral Femoral Component – Fixed Tibia Insert, Range of Motion, according to Standard ISO 21536 and ASTM 2083. Test Report C3, rev.0.

PYROGENICITY:

Bacterial endotoxin test (LAL test) according to European Pharmacopoeia $2.6.14 (which is equivalent to USP chapter <85>)
Pyrogen test according to USP chapter <151> for pyrogenicity determination.
A Clinical Studies:
No clinical studies were conducted. ●

VIII. Conclusion:

Based on the above information, the MOTO™ Lateral Partial Knee System 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 MOTO™ Lateral Partial Knee System implants are as safe and effective as the predicate devices JOURNEY Unicondylar Femoral Implant (K073175); JOURNEY Unicondylar Tibial Baseplates (K102069); ZIMMER Unicompartimental Knee System (K033363) and MOTO Partial Knee System (K162084).

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.