(64 days)
Not Found
No
The summary describes a mechanical knee prosthesis and its design modifications. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance evaluation relies on finite element analysis and risk analysis, not data-driven learning methods.
Yes
The device, a knee prosthesis, is designed for total knee arthroplasty to alleviate severe pain and disability caused by conditions like arthritis and avascular necrosis, which directly fits the definition of a therapeutic device.
No
Explanation: The device is a knee prosthesis, which is a replacement part for a knee joint, not a tool used to diagnose medical conditions. Its intended use is described as being for "total knee arthroplasty," which is a surgical procedure.
No
The device description clearly describes physical components (femoral components, tibial baseplate, liners, stems) of a knee prosthesis, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total knee arthroplasty, addressing conditions like arthritis and avascular necrosis. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical components of a knee prosthesis (femoral components, tibial baseplate, liners, stems). This is consistent with a medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the GMK knee prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GMK knee prosthesis 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 polvarthritis.
- · Avascular necrosis of femoral condyle.
- Post traumatic loss of joint configuration.
- · Primary implantation failure.
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The GMK Narrow Femoral Components are intermediate sizes within the 510(k) cleared size range of the K090988 GMK Total Knee System. GMK Narrow components are designed with the same AP dimension as the correspondent K090988 GMK Total Knee System components (from Size 2 to Size 6) but with a reduced ML dimension of 4 mm. The reduced ML dimension of 4mm corresponds to an "X-1" size of the K090988 GMK Femur in the ML plane. The articular surfaces profile remains the same as the existing femoral components, both for the condyles and the trochlear groove. GMK Narrow Femoral Components are provided in the STD cemented version (to be used with STD and UC fixed tibial inserts) and in the PS cemented version (to be used with PS fixed tibial inserts).
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
Prescription Use
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)
GMK Narrow was evaluated using finite element method (FEM) analysis to demonstrate that the GMK Narrow Femoral Components do not represent worst case conditions compared to the predicate devices and that no further mechanical tests are necessary.
The modification to the device system to include the addition of the GMK Narrow was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The testing was compared to the worst case component size and option/design based on engineering analysis. The GMK Narrow was compared to the worst case K090988 GMK Total Knee components in terms of stress distribution, ROM, constraints, mobility and wear behavior and it was determined that the GMK Narrow femoral components are not worst case.
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
K122232(113)
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a sans-serif font, with two triangular shapes above the "M". Below the word "Medacta" is a horizontal line, and below that is the word "International" with a plus sign to the right of the word. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
SEP
2 8 2012
510(k) Summary
Applicant/Sponsor: 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: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com
Date Prepared: July 20, 2012
DEVICE INFORMATION
Trade/Proprietary Name: GMK Narrow Common Name: Total Knee Prosthesis Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
21 CFR 888.3560 Class II Device Product Codes: JWH
Predicate Devices:
K090988 GMK Total Knee System (Medacta International) K120790 GMK - Line Extension (Medacta International)
GMK Narrow 510(k)
1
Product Description
The GMK Narrow Femoral Components are intermediate sizes within the 510(k) cleared size range of the K090988 GMK Total Knee System. GMK Narrow components are designed with the same AP dimension as the correspondent K090988 GMK Total Knee System components (from Size 2 to Size 6) but with a reduced ML dimension of 4 mm. The reduced ML dimension of 4mm corresponds to an "X-1" size of the K090988 GMK Femur in the ML plane. The articular surfaces profile remains the same as the existing femoral components, both for the condyles and the trochlear groove. GMK Narrow Femoral Components are provided in the STD cemented version (to be used with STD and UC fixed tibial inserts) and in the PS cemented version (to be used with PS fixed tibial inserts).
Indications for Use
The GMK knee prosthesis 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 polvarthritis.
- · Avascular necrosis of femoral condyle.
- Post traumatic loss of joint configuration.
- · Primary implantation failure.
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
Comparison to Predicate Devices
The indications for use of the GMK Narrow are identical to K120790 GMK - Line Extension. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. In terms of design features, GMK Narrow components are designed with the same AP dimension as the correspondent K090988 GMK Total Knee System femoral components (from Size 2 to Size 6) but with a reduced ML dimension of 4 mm. The reduced ML dimension of 4mm corresponds to an "X-1" size of the K090988 GMK Femur in the ML plane. The articular surfaces profile remains the same as the existing femoral components, both for the condyles and the trochlear groove. In terms of materials, GMK Narrow components are made from Cobalt Chromium Molybdenum (CoCrMo) according to ISO5832-4:1996, Implants for Surgery -
2
Metallic materials - Part 4: Cobalt-chromium-molybdenum Casting Alloy which is the same as the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the GMK Narrow are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Performance Testing
GMK Narrow was evaluated using finite element method (FEM) analysis to demonstrate that the GMK Narrow Femoral Components do not represent worst case conditions compared to the predicate devices and that no further mechanical tests are necessary.
The modification to the device system to include the addition of the GMK Narrow was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with predefined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The testing was compared to the worst case component size and option/design based on engineering analysis. The GMK Narrow was compared to the worst case K090988 GMK Total Knee components in terms of stress distribution, ROM, constraints, mobility and wear behavior and it was determined that the GMK Narrow femoral components are not worst case.
Conclusion:
Based on the above information, the GMK Narrow can be considered as substantially equivalent to its predicate devices.
3
Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a globe or sphere.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medacta International % Medacta USA Mr. Adam Gross Director of Regulatory and Quality 4725 Calle Quetzal, Unit B Camarillo, California 93012
Received: August 29, 2012
Re: K122232
Trade/Device Name: GMK Narrow 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 Dated: August 28, 2012
Dear Mr. Gross:
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.
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
EP 28 2012
4
Page 2 - Mr. Adam Gross
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K12232 (111)
Indications for Use
510(k) Number (if known):
Device Name: GMK Narrow
Indications for Use:
The GMK knee prosthesis 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.
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart.C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices |
| GMK Narrow 510(k) | |
|---|---|
| July 24, 2012 | |
| 510(k) Number | K122232 |
| Section 4 - Page 2 of 2 |