(88 days)
No
The description focuses on patient-specific surgical guides derived from imaging data, but there is no mention of AI or ML being used in the design or function of these guides. The validation is based on non-clinical tests and equivalence to predicate devices, not performance metrics typically associated with AI/ML models.
No.
The device is a surgical instrument used to assist in the positioning and guiding of components during total knee replacement surgery, rather than directly treating or preventing a disease.
No
The device is a surgical instrument used for positioning total knee replacement components and guiding bone marking, not for diagnosing a medical condition.
No
The device description explicitly states "Materialise TKA Guides are patient-specific medical devices that are designed to implant total knee prosthesis during total knee arthroplasty surgical procedures." and "Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s)." This indicates the device includes physical components (guides/templates) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "surgical instrument to assist in the intra-operative positioning of total knee replacement components and in guiding the marking of bone before cutting." This describes a tool used during surgery on a patient's body, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces this by calling them "patient-specific medical devices that are designed to implant total knee prosthesis during total knee arthroplasty surgical procedures."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on laboratory tests.
The device is a surgical guide used to facilitate a surgical procedure, which falls under the category of surgical instruments or guides, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Pin Placement Guides
The Materialise TKA Guide System is 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 Guide System 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 Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Metal™, 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, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR and Omni Apex PS prostheses families only.
The Materialise TKA Guides are intended for single use only.
Cut-Through Guides
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacements and in guiding the marking of bone before cutting of the bone.
The Materialise TKA Guide System must be used in conjunction with 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG, OIY, MBH
Device Description
Materialise TKA Guides are patient-specific medical devices that are designed to implant total knee prosthesis during total knee arthroplasty surgical procedures.
The Materialise TKA Guides must only 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 Flex fixed bearing, Zimmer Persond™ CR fixed bearing, Zimmer Persong™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, 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, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS total knee prostheses. Consult the prosthesis labeling and instructions for use for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT images
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical instrument/procedure
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Materialise TKA Guide System was validated though non-clinical tests to verify the system is adequate to perform as intended and to determine substantial equivalence. Previous testing for biocompatibility, sterility, debris, dimensional stability are applicable to the subject device and demonstrate substantial equivalence with the predicate devices. An updated packaging test is performed. Previous testing that the accuracy and performance of the system is adequate to perform as intended is applicable to the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
February 2, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Materialise NV Oliver Clemens Regulatory Officer Technologielaan 15 Leuven, 3001 BELGIUM
Re: K173445
Trade/Device Name: Materialise TKA Guide System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY, MBH Dated: November 6, 2017 Received: November 6, 2017
Dear Oliver Clemens:
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Oliver Clemens
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -S
for 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) K173445
Device Name Materialise TKA Guide System
Indications for Use (Describe) Pin Placement Guides
The Materialise TKA Guide System is 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 Guide System 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 Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Metal™, 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, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR and Omni Apex PS prostheses families only.
The Materialise TKA Guides are intended for single use only.
Cut-Through Guides
The Materialise TKA Guide System is 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 of the bone.
The Materialise TKA Guide System must be used in conjunction with 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.
| Type of Use ( Select one or both, as applicable ) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
| 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 62 80 |
| Fax number | +32 16 39 66 06 |
| Principal Contact person | Oliver Clemens |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | Regulatory.Affairs@materialise.be |
| Additional contact person | Wim Claassen |
| Contact title | Portfolio Manager |
| Contact e-mail address | Wim.Claassen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is October 31, 2017
Submission information
| Trade Name | Materialise TKA Guide System |
|---|---|
| Common Name | Knee prosthesis |
| Classification Name | Knee joint patellofemorotibial polymer /metal /polymer semi-constrained cemented prosthesis |
| Primary product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | OIY, OOG, MBH |
Predicate Devices
The predicate devices to which substantial equivalence is claimed:
| Trade or proprietary or model name | Materialise TKA Guide System |
|---|---|
| ------------------------------------ | ------------------------------ |
5
| 510(k) number | K162273 |
|---|---|
| Decision date | November 7, 2016 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Signature Personalized Patient Care System |
|---|---|
| 510(k) number | K110415 |
| Decision date | May 16, 2011 |
| Classification product code | HRY (21 CFR 888.3530) |
| Subsequent product codes | JWH, MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
| Trade or proprietary or model name | Zimmer Patient Specific Instruments System |
|---|---|
| 510(k) number | K140027 |
| Decision date | May 22, 2014 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
The reference devices used to support a determination of substantial equivalence:
| Trade or proprietary or model name | Kuvia3D |
|---|---|
| 510(k) number | K161559 |
| Decision date | June 23rd, 2016 |
| Classification product code | LLZ (21 CFR 892.2050) |
| Manufacturer | 4QIMAGING, LLC DBA QMETRICS |
6
Device Description
Materialise TKA Guides are patient-specific medical devices that are designed to implant total knee prosthesis during total knee arthroplasty surgical procedures.
The Materialise TKA Guides must only 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 Flex fixed bearing, Zimmer Persond™ CR fixed bearing, Zimmer Persong™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, 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, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS total knee prostheses. Consult the prosthesis labeling and instructions for use for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).
Intended Use
Pin Placement Guides
The Materialise TKA Guide System is 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 Guide System 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 Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, 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 PS prostheses families only.
The Materialise TKA Guides are intended for single use only.
Cut-Through Guides
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacements and in guiding the marking of bone before cutting of the bone.
The Materialise TKA Guide System must be used in conjunction with 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.
Functioning of the Device
The Materialise TKA Guide System generates a pre-surgical plan based on MRI or CT images using the Materialise TKA Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve
Materialise N.V.
7
510(k) Summary
the pre-surgical plan. Next, Materialise TKA Guides are designed and manufactured based on the approved presurgical 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.
Technological Characteristics
A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the predicate device.
Performance Data
Materialise TKA Guide System was validated though non-clinical tests to verify the system is adequate to perform as intended and to determine substantial equivalence. Previous testing for biocompatibility, sterility, debris, dimensional stability are applicable to the subject device and demonstrate substantial equivalence with the predicate devices. An updated packaging test is performed. Previous testing that the accuracy and performance of the system is adequate to perform as intended is applicable to the subject device.
Summary
The characteristics that determine the functionality and performance of the Materialise TKA Guide System are substantially equivalent to the device cleared under K162273, K110415 and K140027. The nonclinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate. The Materialise TKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.