The MOTO™ 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 compartment of the joint is affected due to the compartmental primary degenerative or posttraumatic decenerative disease, previous tibial condule or plateau fractures, deformity or revious arthroplasty.

The MOTO™ PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases:

· Osteoarthritis, post-traumatic arthritis, severe chondrocalcinosis of the patellofemoral joint.
· Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation).
· History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.
· Degeneration induced by dysplasia.

If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.

Device Description

The MOTO™ Partial Knee & MOTO™ PFJ Systems is a line extension to provide a larger product offering. The subject devices are sterile implantable devices designed for cemented use in partial knee arthroplasty procedures. The MOTO™ Partial Knee & MOTO™ PFJ Systems extension includes:

Medial femoral components TiNbN coated, left medial, sizes from 1 to 10; ●
Lateral femoral components TiNbN coated, sizes from 1 to 7; ●
Medial tibial inserts fixed E-cross, left medial and right medial, sizes from 1 to 8 and 6 thicknesses ● from 8 to 14;
. Lateral tibial inserts fixed E-cross, sizes from 1 to 8 and 6 thicknesses from 8 to 14;
. Patello Femoral Joint TiNbN coated, left and right, sizes from 1 to 6;
MOTO Patella E-cross, 6 sizes. ●

The subject femoral components, as well as the patello femoral joint, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 with Titanium Nitride (TiNbN) coating.

The subject tibial inserts, as well as the MOTO patella, are made of E-Cross (Vitamin-E Highly Crosslinked UHMWPE).

AI/ML Overview

This looks like a 510(k) Summary for a medical device, which typically describes a device's substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study proving the device meets those criteria from scratch. The document states that no clinical studies were conducted (page 7). Therefore, it directly addresses several of your points by stating they are not applicable or were not performed.

Here's a breakdown of the provided information relative to your request:

Acceptance Criteria and Study for This Specific Device

The document does not present a table of acceptance criteria for a new, independent performance study and then report the device's performance against those criteria. Instead, it asserts substantial equivalence to predicate devices based on technological characteristics and performance testing. The "performance testing" described (Section VII) is primarily non-clinical and aims to demonstrate that the new variations of the device (e.g., new materials for inserts, new coatings for femoral components) perform similarly to or are at least as safe and effective as the existing predicate devices.

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

This information is not provided in the document in the format requested for this specific device as if it were an entirely new product undergoing de-novo evaluation against explicit performance criteria. The document states:

"Based on the risk analysis, performance testing were conducted to written protocols." (page 6)
It lists various performance tests conducted (e.g., mechanical performance, wear behavior, static ML shear, AP draw test, contact pressures, constraint comparison) and notes they were performed "according to ASTM F2083" or "European Pharmacopoeia." These standards inherently contain their own acceptance criteria, but these specific criteria and the detailed results showing compliance are not presented in this summary document. The summary only states that these tests were performed to support substantial equivalence.

2. Sample size used for the test set and the data provenance

Sample Size: The sample sizes for the non-clinical performance tests are not specified in this summary document.
Data Provenance: The studies are non-clinical (laboratory testing) and were conducted to support the substantial equivalence of device modifications. The country of origin of the data is not explicitly stated beyond Medacta's corporate locations (Switzerland and USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. Since no clinical studies were conducted and the performance tests are mechanical/material-based, there was no "ground truth" derived from expert consensus on patient data.

4. Adjudication method for the test set

This is not applicable for the same reason as point 3.

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

This is not applicable. This device is an orthopedic implant (knee prosthesis components), not an AI diagnostic imaging device.

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

This is not applicable. This device is an orthopedic implant.

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

This is not applicable in the traditional sense of clinical ground truth. For the non-clinical performance testing, the "ground truth" would be established by the specifications in the relevant ASTM standards or pharmacopoeia, which define the expected performance or material properties.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as point 8.

Summary of what is available from the document:

No Clinical Studies: The document explicitly states, "No clinical studies were conducted" (page 7).
Basis for Clearance: Substantial equivalence is claimed based on a comparison of technological characteristics (indications for use, sizes, shape, fixation, biocompatibility, device usage, sterility, shelf-life, packaging) with predicate devices (K162084, K183029, K200122).
Non-Clinical Performance Testing: A range of non-clinical tests were performed (mechanical, wear, static shear, contact pressure, constraint) on the specific components with new materials/coatings (TiNbN coated femoral components/PFJ, E-Cross tibial inserts/patella). These tests were conducted according to various standards (e.g., ASTM F2083, European Pharmacopoeia $2.6.14, USP chapter <151>). The specific results are not detailed, but the conclusion is that these data support substantial equivalence.
No "Acceptance Criteria Table" or "Study Proving Acceptance" in the requested format: The document does not provide a direct table of acceptance criteria and reported performance outcomes for a de novo submission. Instead, it supports substantial equivalence within the framework of a 510(k) by demonstrating that new device elements perform comparably to previously cleared predicate devices according to established engineering and material standards.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.

November 16, 2021

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

Re: K213071

Trade/Device Name: MOTO™ Partial Knee & MOTO PFJ Systems Extension Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, KRR, JWH, NPJ Dated: November 11, 2021 Received: November 12, 2021

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,

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)

Device Name

MOTO™ Partial Knee & MOTO PFJ Systems Extension

Indications for Use (Describe)

o MOTO™ Partial Knee System

o MOTO™ PFJ System

· Osteoarthritis, post-traumatic arthritis, severe chondrocalcinosis of the patellofemoral joint.
· Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation).
· History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.
· Degeneration induced by dysplasia.

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)

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}------------------------------------------------

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 of Quality and Regulatory, Medacta USA Date Prepared: September 22, 2021 Date Revised: November 12, 2021

II. Device

Device Proprietary Name:	MOTO™ Partial Knee & MOTO PFJ Systems Extension
Common or Usual Name:	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented,Metal/Polymer
Classification Name:	Knee joint femorotibial metal/polymer non-constrainedcemented prosthesis
Primary Product Code	HSX
Secondary Product Code:	KRR, JWH, NPJ
Regulation Number:	21 CFR 888.3520, 21 CFR 888.3540 and 21 CFR 888.3560
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device

MOTO™ Partial Knee System, K162084, Medacta International SA
Additional predicate devices
MOTO™ Lateral Partial Knee System, K183029, Medacta International SA
MOTO™ PFJ System, K200122, Medacta International SA

Additional reference devices

GMK Sphere E-cross, K202022, Medacta International SA
GMK Total Knee System TiNbN Coating, K202684, Medacta International SA

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

IV. Device Description

The purpose of this submission is to gain clearance for the MOTO™ Partial Knee & MOTO™ PFJ Systems Extension and to extend the compatibility of the already cleared MOTO Patella. Specifically, both the new MOTO Patella and the already cleared one (K200122) may be used in the following combinations:

. with the MOTO PFJ
with the MOTO PFJ and with the MOTO Partial Knee System (K162084, K183029), GMK UNI ● (K162084).
alone (without MOTO PFJ) with the GMK Primary or GMK Sphere devices (K090988, ● K120790, K121416, K122232, K140826, K142069 and K202684) or GMK Spherika (K211004).

Medial femoral components TiNbN coated, left medial, sizes from 1 to 10; ●
Lateral femoral components TiNbN coated, sizes from 1 to 7; ●
Medial tibial inserts fixed E-cross, left medial and right medial, sizes from 1 to 8 and 6 thicknesses ● from 8 to 14;
. Lateral tibial inserts fixed E-cross, sizes from 1 to 8 and 6 thicknesses from 8 to 14;
. Patello Femoral Joint TiNbN coated, left and right, sizes from 1 to 6;
MOTO Patella E-cross, 6 sizes. ●

The subject femoral components, as well as the patello femoral joint, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 with Titanium Nitride (TiNbN) coating.

The subject tibial inserts, as well as the MOTO patella, are made of E-Cross (Vitamin-E Highly Crosslinked UHMWPE).

Indications for Use V.

MOTO™ Partial Knee System

The MOTOM 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 compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

o MOTO™ PFJ System

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

. Osteoarthritis, post-traumatic arthritis, severe chondrocalcinosis of the patellofemoral joint.
Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, ● cartilage transplantation).
History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral . joint.
Degeneration induced by dysplasia. ●

Comparison of Technological Characteristics VI.

The MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants and the predicate devices (K162084, K183029 and K200122) share the following characteristics:

indications for use; ●
sizes: ●
shape and design: ●
fixation and stability;
biocompatibility; ●
. device usage:
sterility; ●
shelf-life; and ●
packaging.

The MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants differ from the predicate devices (K162084, K183029 and K200122) as follow:

MOTO tibial inserts and MOTO Patella material; and .
femoral components and MOTO PFJ coating. .

Discussion

Medacta International SA has not made any change to the indications for use, sizes, general design and shape, fixation and stability features, 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 MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants to the identified predicate devices.

VII. Performance Data

Based on the risk analysis, performance testing were conducted to written protocols. The following tests and rationales are provided in support of the substantial equivalence determination: Non-Clinical Studies

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

PERFORMANCE TESTING .
- TiNbN coated MOTO Femoral component Mechanical performances о
- TiNbN coated MOTO Femoral component Wear behavior o
- TiNbN coating Excessive Ions release o
- TiNbN coated PFJ implant Mechanical performances o
- TiNbN coated PFJ implant Wear behavior O
- E-Cross MOTO medial and lateral tibial inserts Wear behavior. ROM and constraints O rationale
- MOTO Partial knee system E-Cross medial and lateral tibial inserts: static ML SHEAR and O AP draw test of the insert-tray clipping system according to ASTM F2083
- MOTO E-Cross tibial inserts Contact pressures and areas according to ASTM F2083 о
- Contact pressure and areas: MOTO Patella articulating on GMK-Sphere & GMK-Primary o femoral component
- Constraint comparison within Medacta MOTO Patella & Medacta EVOLIS Patella in terms O of jump height
- E-Cross MOTO Patella Wear behavior, ROM and constraints rationale o
- Constraints equivalence of GMK Resurfacing and MOTO Patella articulating with GMK o Spherika femoral component and GMK Spherika anatomical femoral component and the predicated device
- Contact areas equivalence of GMK Resurfacing and MOTO Patella articulating with GMK о Spherika femoral component and GMK Spherika anatomical femoral component and the predicated device
PYROGENICITY ●
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia $2.6.14 (which is o equivalent to USP chapter <85>)
- o Pyrogen test according to USP chapter <151> for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free. o
BIOCOMBATIBILITY evaluation .
SHELF-LIFE evaluation ●

Clinical Studies:

No clinical studies were conducted. ●

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

VIII. Conclusion

The information provided above supports that the MOTO™ Partial Knee & MOTO™ PFJ Systems Extension implants are substantially equivalent to the predicate devices.

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.