(87 days)
Not Found
No
The document describes a knee replacement system made of specific materials and designs, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is a total knee replacement system designed to alleviate pain and disability caused by conditions like arthritis and avascular necrosis, which directly indicates a therapeutic purpose.
No
The device is a knee replacement system intended for total knee arthroplasty, which is a treatment for joint conditions, not a tool for diagnosing them.
No
The device description clearly states that the device is a "line extension to the GMK Total Knee System" and includes physical implants such as "femoral and tibial components" made from "cobalt-chromium-molybdenum alloy" and "Ultra High Molecular Weight Polyethylene". This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for total knee arthroplasty to treat conditions like arthritis and avascular necrosis. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is described as a system of implants (femoral and tibial components) made of metallic and polyethylene materials, designed for surgical implantation. This aligns with a medical device for surgical use, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or monitor a patient's health status.
- Performance Studies: The performance studies focus on mechanical resistance, wear testing, coating characterization, pyrogenicity, and biocompatibility – all relevant to the safety and performance of a surgical implant, not an IVD.
In summary, the GMK Total Knee System is a surgical implant intended for therapeutic use in replacing a damaged knee joint. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- · Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, rheumatoid arthritis.
- Avascular necrosis of femoral condyle.
- · Post traumatic loss of joint configuration.
- · Primary implantation failure.
GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.
- · Collagen disorders, and/or avascular necrosis of the femoral condyle.
- · Moderate valgus, varus, or flexion deformities.
- Cemented tibial wedges are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate.
In the case of a semi-constrained liner is being used, an extension stem must be implanted both on the femoral components. In the case a GMK Revision tibial tray is being used, an extension stem must be implanted.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The GMK Total Knee System - TiNbN Coating is a line extension to the GMK Total Knee System to provide a larger product offering. The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures where there is evidence of sufficient sound bone to seat and support for the implants. GMK Total Knee System - TiNbN Coating includes the following implants:
- o GMK Femoral Component, Standard and Posterior Stabilized, Left and Right, Sizes from 0 to 7
- . GMK Femoral Component Narrow, Standard and Posterior Stabilized, Left and Right, Sizes from 1 to 7
- GMK-Sphere Femoral Component, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ . (intermediate sizes)
- 0 Tibial tray fixed cemented. Left and Right, Sizes from 1 to 6 plus 4 intermediate sizes.
The GMK Total Knee System - TiNbN Coating implants, both Femoral Components and Tibial Tray, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery - Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Nitride (TiNbN) coating. The GMK Total Knee System -TiNbN Coating: Fixed Tibial Tray Plug is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Studies:
- PERFORMANCE TESTING
- o Evaluation of modular tapered connection according to Medacta Test Protocol IL 07.09.517 rev.0 and Medacta Test Report A.2, and Endolab Test Report 167.181121.20.87 Rev.0
- Wear test 3 Mode according to Medacta Test Protocol IL 07.09.513 Rev. 2 and Medacta O Test Report A.3 and Element Test Reports 00812-010290-1 and 00812-010290-3
- Coating characterization according to ISO 11885 O
- The following performance tests were previously conducted on the predicate devices O and reviewed as part of the GMK Total Knee System submissions K090988. K120790. K121416, K12232, K140826 and K142069:
- . mechanical resistance of the femoral component under physiological static and dynamic loads:
- mechanical resistance of the tibial tray under physiological static and dynamic loads:
- connection of the tibial tray with the tibial insert.
- PYROGENICITY ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination O
- The subject devices are not labeled as non-pyrogenic or pyrogen free O
- BIOCOMPATIBILITY
- Biocompatibility assessment and related testing as per ISO 10993 series and FDA O Biocompatibility Guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Clinical Studies:
- No clinical studies were conducted
Key results: Based on the information, the GMK Total Knee System - TiNbN Coating implants can be considered substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The GMK Total Knee System -TiNbN Coating implants are as safe and effective as the predicate devices.
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.
K090988, K120790, K121416, K122232, K140826, K142069, K152431
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
December 11, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K202684
Trade/Device Name: GMK Total Knee System - TiNbN Coating Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 15, 2020 Received: September 15, 2020
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)
K202684
Device Name GMK Total Knee System - TiNbN Coating
Indications for Use (Describe)
The GMK Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- · Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, rheumatoid arthritis.
- Avascular necrosis of femoral condyle.
- · Post traumatic loss of joint configuration.
- · Primary implantation failure.
GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.
- · Collagen disorders, and/or avascular necrosis of the femoral condyle.
- · Moderate valgus, varus, or flexion deformities.
- Cemented tibial wedges are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate.
In the case of a semi-constrained liner is being used, an extension stem must be implanted both on the femoral components. In the case a GMK Revision tibial tray is being used, an extension stem must be implanted.
| 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) |
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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, Director of Quality and Regulatory, Medacta USA Date Prepared: September 11, 2020
II. Device
| Device Proprietary Name: | GMK Total Knee System - TiNbN Coating |
|---|---|
| Common or Usual Name: | Total Knee Prosthesis |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- |
| constrained cemented prosthesis | |
| Primary Product Code: | JWH |
| Regulation Number: | 21 CFR 888.3560 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- GMK Total Knee System, K090988, Medacta International SA ●
- GMK-Line Extension, K120790, Medacta International SA (also referred to as the GMK Total Knee System)
- GMK Sphere, K121416, Medacta International SA (also referred to as the GMK Total Knee System)
- GMK Narrow, K122232, Medacta International SA (also referred to as the GMK Total Knee System)
- GMK Sphere Extensions, K140826, Medacta International SA (also referred to as the ● GMK Total Knee System)
- GMK Extension, K142069, Medacta International SA (also referred to as the GMK Total Knee System)
- LINK® Endo-Model® Knee System with PorEx® (TiNbN) Coating, K152431, Waldemar 0 Link GmbH & Company KG
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Device Description IV.
The GMK Total Knee System - TiNbN Coating is a line extension to the GMK Total Knee System to provide a larger product offering. The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures where there is evidence of sufficient sound bone to seat and support for the implants. GMK Total Knee System - TiNbN Coating includes the following implants:
- o GMK Femoral Component, Standard and Posterior Stabilized, Left and Right, Sizes from 0 to 7
- . GMK Femoral Component Narrow, Standard and Posterior Stabilized, Left and Right, Sizes from 1 to 7
- GMK-Sphere Femoral Component, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ . (intermediate sizes)
- 0 Tibial tray fixed cemented. Left and Right, Sizes from 1 to 6 plus 4 intermediate sizes.
The GMK Total Knee System - TiNbN Coating implants, both Femoral Components and Tibial Tray, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery - Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Nitride (TiNbN) coating. The GMK Total Knee System -TiNbN Coating: Fixed Tibial Tray Plug is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.
V. Indications for Use
The GMK. Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- o Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
- Avascular necrosis of femoral condyle. .
- Post traumatic loss of joint configuration. ●
- Primary implantation failure. ●
GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid . arthritis or polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle. .
- Moderate valgus, varus, or flexion deformities. 0
Cemented tibial wedges are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate.
In the case of a semi-constrained liner is being used, an extension stem must be implanted both on the tibial and on the femoral components. In the case a GMK Revision tibial tray is being used, an extension stem must be implanted.
5
VI. Comparison of Technological Characteristics
The GMK Total Knee System - TiNbN Coating and the predicate devices GMK Total Knee System (K090988, K120790, K121416, K122232, K140826, K142069) share the following characteristics:
- indication for use
- design: ●
- fixation
- substrate material; ●
- device usage;
- sterility: ●
- shelf life; and ●
- o packaging.
The GMK Total Knee System - TiNbN Coating differs from the predicate devices GMK Total Knee System (K090988, K120790, K121416, K122232, K140826, K142069) in relation to the coating only as the subject devices have a TiNbN coating while the predicate devices have no coating.
Performance Data VII.
Based on the risk analysis, testing was conducted according to written protocols. The following tests are being provided in support of a substantial equivalence determination:
Non-Clinical Studies:
- PERFORMANCE TESTING
- o Evaluation of modular tapered connection according to Medacta Test Protocol IL 07.09.517 rev.0 and Medacta Test Report A.2, and Endolab Test Report 167.181121.20.87 Rev.0
- Wear test 3 Mode according to Medacta Test Protocol IL 07.09.513 Rev. 2 and Medacta O Test Report A.3 and Element Test Reports 00812-010290-1 and 00812-010290-3
- Coating characterization according to ISO 11885 O
- The following performance tests were previously conducted on the predicate devices O and reviewed as part of the GMK Total Knee System submissions K090988. K120790. K121416, K12232, K140826 and K142069:
- . mechanical resistance of the femoral component under physiological static and dynamic loads:
- mechanical resistance of the tibial tray under physiological static and dynamic loads:
- connection of the tibial tray with the tibial insert.
6
Medacta International SA
PYROGENICITY ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination O
- The subject devices are not labeled as non-pyrogenic or pyrogen free O
- 0 BIOCOMPATIBILITY
- Biocompatibility assessment and related testing as per ISO 10993 series and FDA O Biocompatibility Guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Clinical Studies
- No clinical studies were conducted ●
VIII. Conclusion
Based on the above information, the GMK Total Knee System - TiNbN Coating implants can be considered substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The GMK Total Knee System -TiNbN Coating implants are as safe and effective as the predicate devices, GMK Total Knee System (K090988, K120790, K121416, K122232, K140826, K142069).