(87 days)
Not Found
No
The summary describes a patient-specific surgical guide system based on imaging scans, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a surgical instrument intended to assist in the positioning of total knee replacement components intra-operatively, not to provide therapy.
No
The device is described as a "surgical instrument" and "patient-specific medical device" intended to assist in the "positioning of total knee replacement components intra-operatively." It is used for guiding surgical procedures, not for diagnosing a medical condition.
No
The device description explicitly states "Materialise TKA Guides are patient-specific medical devices" and "Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s)." This indicates the device includes physical components (templates/guides) in addition to any potential software used in their design.
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 positioning of total knee replacement components intra-operatively and in guiding the marking". This describes a surgical tool used during a procedure on the patient's body.
- 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."
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on biological samples.
The device is a surgical guide used directly on the patient's anatomy during surgery, which falls under the category of a surgical instrument or medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Materialise TKA Guide System is to be used 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 Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular 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 total knee prostheses during total knee arthroplasty surgical procedures.
The Materialise TKA Guides are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY, OOG, 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 images
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeon / intra-operatively
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)
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, biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. The patient specific templates were subjected to a sawbone validation test in order to validate the use of the Materialise TKA Guide System and to demonstrate that the performance of the subject device is substantially equivalent to the predicate device (K150928) with respect to transferring a pre-surgical plan to actual patient anatomy in a simulated environment. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2016
Materialise NV Oliver Clemens Regulatory Officer Technologielaan 15 Leuven, 3001 BE Belgium
Re: K162273 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, OIY, OOG, MBH Dated: August 10, 2016 Received: August 12, 2016
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162273
Device Name Materialise TKA Guide System
Indications for Use (Describe)
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Materialise TKA Guide System is to be used 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 Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular 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 total knee prostheses during total knee arthroplasty surgical procedures.
The Materialise TKA Guides are intended for single use only.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 | Orthopedic Guide Portfolio Manager |
| Contact e-mail address | Wim.Claassen@materialise.be |
Submission date
The date of the Traditional 510(k) submission is August 10, 2016
Submission information
| Trade Name | Materialise TKA Planner
Materialise TKA Guide |
|--------------------------|-------------------------------------------------------------------------------------------------|
| 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 |
4
Predicate Devices
The predicate devices to which substantial equivalence is claimed:
| Trade or proprietary or model name | Materialise TKA Guide System |
|---|---|
| 510(k) number | K150928 |
| Decision date | August 10, 2015 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |
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
The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking or bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Materialise TKA Guide System is to be used 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 Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona TM Trabecular 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, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS total knee prostheses during total knee arthroplasty surgical procedures.
The Materialise TKA Guides are intended for single use only.
5
Functioning of the Device
The Materialise TKA Guide System generates a pre-surgical plan based on MRI images using the Materialise TKA Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve 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 and marking drill locations.
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 is compatible with an established list of brands of total knee arthroplasty implants. The subject device is additionally compatible with Lima Physica PS System, Physica CR Knee System, and Physica KR Knee System and Omni Apex CR and Omni Apex PS knee prostheses.
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, biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. The patient specific templates were subjected to a sawbone validation test in order to validate the use of the Materialise TKA Guide System and to demonstrate that the performance of the subject device is substantially equivalent to the predicate device (K150928) with respect to transferring a pre-surgical plan to actual patient anatomy in a simulated environment. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
Summary
The characteristics that determine the functionality and performance of the Materialise TKA Guide System are substantially equivalent to the device cleared under K150928. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate. The Moterialise TKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.