• Pin Placement Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.

The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.

The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System and AGC® Complete Knee system prostheses families only

The Materialise TKA Guides are intended for single use only.

• Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software
The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

Device Description

The Materialise TKA Guide System is a medical device designed to be used to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a presurgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.

The subject device is a system that consists of the following two functional components:

• A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.

• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and to guide cutting of the bone. The patient-specific models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Materialise TKA Guide System describes the device and its indications for use, but it does not contain the specific acceptance criteria or the details of a study (like a clinical study or specific performance data) that proves the device meets those criteria.

Instead, the document primarily focuses on establishing "substantial equivalence" to a predicate device (Materialise TKA Guide System K221337) and a reference device (Materialise PKA Guide System K202207). It states that "The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device." However, it does not provide the actual results of this non-clinical performance testing in terms of specific acceptance criteria and detailed study outcomes.

The information given is typical for a 510(k) summary, which generally affirms that V&V (Verification and Validation) was done and that the device performs as intended, but it doesn't usually include the granular details of the V&V studies themselves, especially not in a public-facing clearance letter. These details would be contained within the full 510(k) submission, which is not publicly accessible in its entirety.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide answers to most of your specific questions (sample size, data provenance, expert details, adjudication, MRMC study, ground truth type, training set details) because this information is not present in the provided text.

The document mentions:

Software verification and validation: "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements, and validation against user needs." This implies acceptance criteria were defined (as "defined requirements" and "user needs") and met, but the specific metrics and results are not listed.
Hardware testing: "Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device (no changes have been applied to the Hardware)." Again, this confirms testing occurred and was successful, but the specific criteria and outcomes are omitted.

In summary, none of the specific data you requested (acceptance criteria, study details, sample sizes, expert qualifications, etc.) are available in the provided FDA 510(k) clearance letter.

To provide the information you're looking for, one would typically need access to the full 510(k) submission, specifically the V&V reports, which are proprietary and not released with the public clearance letter.

Summary

FDA 510(k) Clearance Letter - Materialise TKA Guide System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 14, 2025

Materialise N.V.
Jenny Jones
Global Quality Regulatory Manager
Technologielaan 15
Leuven, 3001
Belgium

Re: K251554
Trade/Device Name: Materialise TKA Guide System
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, MBH, OIY, OOG
Dated: May 20, 2025
Received: May 21, 2025

Dear Jenny Jones:

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 (the 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 available 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

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K251554 - Jenny Jones
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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K251554 - Jenny Jones
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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-devices/device-advice-comprehensive-regulatory-assistance/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,

Lixin Liu -S

Lixin Liu, Ph.D
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K251554

Device Name
Materialise TKA Guide System

Indications for Use (Describe)

Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

• Pin Placement Guides

The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides

The Materialise TKA Guides are intended for single use only.

• Models

The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer

Page 5

NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software

The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

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.

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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.

Page 6

Materialise TKA Guide System

510(k) Premarket Notification

510(k) Summary

Materialise N.V.
Page 1

510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.18

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Postal code	3001
Country	Belgium
Phone number	+32 16 39 66 11
Fax number	+32 16 39 66 06
Primary contact person	Gulia Girola
Contact title	Regulatory Affairs Specialist
Contact e-mail address	Regulatory.Affairs@materialise.be
Additional contact person	Jenny Jones
Contact title	Global Quality Regulatory Manager
Contact e-mail address	Jenny.Jones@materialise.com

Submission date

The date of the Traditional 510(k) submission is May 21st, 2025.

Submission Information

Trade Name	Materialise TKA Guide System
Common Name	Patient specific instrumentation and 3D planning software for total knee replacement system
Classification Name	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Primary product code	JWH (21 CFR 888.3560)
Additional product codes	OIY (21 CFR 888.3560)OOG (21 CFR 888.3560)MBH (21 CFR 888.3565)

K251554 Page 1 of 6

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Materialise TKA Guide System
510(k) Summary

510(k) Premarket Notification
K251554 Page 2 of 6

Predicate Device

The predicate device to which substantial equivalence is claimed:

Trade or proprietary or model name	Materialise TKA Guide System
510(k) number	K221337
Decision date	July 5, 2022
Classification product code	JWH (21 CFR 888.3560)MBH (21 CFR 888.3565)OIY(21 CFR 888.3560)OOG (21 CFR 888.3560)
Manufacturer	Materialise N.V.

Reference device:

Trade or proprietary or model name	Materialise PKA Guide System
510(k) number	K202207
Decision date	October 2, 2020
Classification product code	HSX (21CFR888.3520)OOG (21 CFR 888.3560)
Manufacturer	Materialise N.V.

Indications for Use

Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

• Pin Placement Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.

Materialise N.V.
Page 2

Page 8

Materialise TKA Guide System
510(k) Summary

510(k) Premarket Notification
K251554 Page 3 of 6

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.

The Materialise TKA Guides are intended for single use only.

• Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.

The Materialise TKA Models are intended for single use only.

Software

Materialise N.V.
Page 3

Page 9

Materialise TKA Guide System
510(k) Summary

510(k) Premarket Notification
K251554 Page 4 of 6

software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

Device Description

The subject device is a system that consists of the following two functional components:

• A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.

• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

Functioning of the Device

The Materialise TKA Guide System generates a pre-surgical plan based on MRI or CT images using the SurgiCase Knee Planner. The SurgiCase Knee Planner then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Materialise TKA Guides and Models (models are optional) are designed and manufactured based on the approved pre-surgical plan. Materialise TKA Guides are patient-specific templates which transfer the pre-operatively determined positioning of the chosen total knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual total knee replacement components by guiding the marking of bone before cutting and to guide cutting of the bone. The patient-specific models serve as a visual reference for the surgeon in the operating room.

Technological Characteristics

The Materialise TKA Guide System has an equivalent intended use and the same fundamental scientific technology as the predicate device. The subject device's software is intended for simulation and planning of pre-operational intervention, and for positioning knee components, i.e., tibia and femur components (same as the predicate device and reference device). The subject device's hardware is intended for

K251554 Page 4 of 6

Materialise N.V.
Page 4

Page 10

Materialise TKA Guide System
510(k) Summary

510(k) Premarket Notification
K251554 Page 5 of 6

positioning knee components intra‐operatively and in guiding the marking of bone before cutting and to guide cutting of the bone (same as the predicate device).

Software

The subject software device employs similar fundamental technologies as the predicate software device. Technological similarities include:

• Device functionality: The planning functionality, visualization options and planning features are the same for the knee planning of the subject device as for the predicate device.
• Software technology: The subject device has the same code base as the predicate device and uses exact the same methods for design and verification and validation as the predicate device.

The following technological differences exist between the subject device software and the predicate device software.

The main difference between the subject device and previously cleared predicate device K221337 is that the software component in the subject device now also supports a restricted kinematic alignment planning philosophy based on patient anatomy, in addition to the mechanical alignment planning philosophy which was already present in the predicate device.

The subject software technology differences have been demonstrated to not affect safety or effectiveness or raise different issues of safety or effectiveness compared to the predicate device.

Hardware

The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, raw materials, and performance characteristics to the predicate device K221337.

No changes have been performed on the hardware device with respect to the predicate device. The only changes described in the current submission are applicable to the software device.

Performance Data (non-clinical)

Hardware:

Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device (no changes have been applied to the Hardware).

Software:

Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation against user needs.

K251554 Page 5 of 6

Materialise N.V.
Page 5

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Materialise TKA Guide System
510(k) Summary

510(k) Premarket Notification
K251554 Page 6 of 6

Conclusion

The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device. Therefore, it can be concluded that the Materialise TKA Guide System is substantially equivalent to the predicate device.

Materialise N.V.
Page 6

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.