(94 days)
Not Found
No
The device description and performance studies focus on the mechanical components and testing of a total knee replacement system, with no mention of AI or ML capabilities.
Yes
The device is a knee replacement system used to alleviate pain and disability caused by conditions like arthritis and avascular necrosis, which constitutes a therapeutic purpose.
No
This device is a total knee replacement system, which is an implantable medical device used to replace a diseased or damaged knee joint. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components (femoral, patellar, and tibial components with polyethylene inserts) and mentions performance testing related to these physical components, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Total Knee System designed for cemented use in total knee arthroplasty." This describes a surgical implant used to replace a damaged knee joint.
- Device Description: The description details the physical components of the knee prosthesis (femoral, patellar, and tibial components, inserts, stems). These are all physical implants.
- Anatomical Site: The anatomical site is the "Knee joint," which is a part of the human body, not a sample of bodily fluid or tissue being tested.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a physical condition.
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, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- . avascular necrosis of femoral condyle
- . post traumatic loss of joint configuration
- primary implantation failure.
Product codes
JWH
Device Description
The GMK® Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultrahigh molecular weight polyethylene articular inserts. The femoral components are offered in left and right sizes in a standard and a posterior stabilized design of six sizes. The tibial baseplates are offered in six left and right sizes with an optional extension stem of 65 mm length. The tibial inserts are offered in three styles: standard, posterior-stabilized and ultra-congruent. Each of the three styles is offered in six sizes, corresponding to the tibial base plate sizes, in five thicknesses from 10 - 20 mm each. Tibial inserts work with either the left or right tibial baseplate of that size. The patellar components are offered in two options: an inset patella and a resurfacing patella. The inset patella is offered in the three diameters of 24, 28, and 32 mm and the resurfacing patella is offered in three sizes.
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)
Performance testing of the GMK® Total Knee System was conducted in accordance with various international standards and FDA guidance documents. The GMK® Total Knee System was tested as part of design verification to written protocols with pre-defined acceptance criteria. The protocols and predefined acceptance criteria were based on the above standards and guidance. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that performance of the GMK® Total Knee System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081023, K072858, K043101, K021657
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two black triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is a thin line, and below that is the word "International" in a smaller font. To the right of the word "International" is a small plus sign.
JUL 1 0 2009
510(k) Summary
Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX
Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com
Date Prepared: March 31, 2009
DEVICE INFORMATION
Trade/Proprietary Name: GMK® - Total Knee System Common Name Total Knee Prosthesis Classification Name: Knee joint patellofemorotibial metal/polymer/metal semiconstrained cemented prosthesis, 21 CFR 888.3560
Predicate Devices:
K081023 Evolis Total Knee System (Medacta International) K072858 TC Plus Primary Knee System (Smith and Nephew) K043101 NexGen® Complete Knee Solution MIS Tibial Components (Zimmer) K021657 UKNEE Total Knee System (United Orthopedic Corporation)
Product Description:
The GMK® Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultrahigh molecular weight polyethylene articular inserts. The femoral components are offered in left and right sizes in a standard and a posterior
GMK® Total Knee System 510(k)
Section 5 - Page 2 of 4
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stabilized design of six sizes. The tibial baseplates are offered in six left and right sizes with an optional extension stem of 65 mm length. The tibial inserts are offered in three styles: standard, posterior-stabilized and ultra-congruent. Each of the three styles is offered in six sizes, corresponding to the tibial base plate sizes, in five thicknesses from 10 - 20 mm each. Tibial inserts work with either the left or right tibial baseplate of that size. The patellar components are offered in two options: an inset patella and a resurfacing patella. The inset patella is offered in the three diameters of 24, 28, and 32 mm and the resurfacing patella is offered in three sizes.
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, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- . avascular necrosis of femoral condyle
- . post traumatic loss of joint configuration
- primary implantation failure. .
Comparison to Predicate Devices
The GMK® Total Knee System has the same indications for use as the main predicate device, the Evolis Total Knee System. The GMK® Total Knee System components are made of the same type of materials for each component as one or more of the predicate devices. The GMK® Total Knee System components' design and technological characteristics are similar to one or more of the predicate devices. The GMK® Total Knee System components are packaged and sterilized in the manner as the main predicate, the Evolis Total Knee System.
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the GMK® Total Knee System was conducted in accordance with various international standards and FDA guidance documents.
The GMK® Total Knee System was tested as part of design verification to written protocols with pre-defined acceptance criteria. The protocols and predefined acceptance criteria were based on the above standards and guidance. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that performance of the GMK® Total Knee System is substantially equivalent to the predicate devices.
GMK® Total Knee System 510(k)
Section 5 - Page 3 of 4
2
Conclusion:
The data and information provided in this submission support the conclusion that the GMK® Total Knee System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
GMK® Total Knee System 510(k)
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Section 5 - Page 4 of 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medacta International, SA c/o Ms. Natalie J. Kennel Consultant, NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129
Re: K090988
Trade/Device Name: GMK® Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, Patellofemorotibial, metal/polymer/metal, semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 15, 2009 Received: June 17, 2009
JUL 1.0 2009
Dear Ms. Kennel:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
4
Page 2 - Ms. Natalie J. Kennel
forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for. the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milherson
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K090988
Indications for Use Statement
510(k) Number (if known): Koqoq 8 B
Device Name: GMK® Total Knee System
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, traumatic 1 arthritis, rheumatoid arthritis or polyarthritis
- . avascular necrosis of femoral condyle
- post traumatic loss of joint configuration
- primary implantation failure.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anita
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090988
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