(85 days)
Not Found
No
The summary describes a mechanical knee prosthesis and its components. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies. The performance studies focus on mechanical properties and comparison to predicate devices.
Yes
The device is a knee prosthesis designed for total knee arthroplasty to treat severely painful and/or disabled joints, which directly addresses a medical condition.
No
Explanation: The device is a knee prosthesis designed for use in total knee arthroplasty, which is a therapeutic treatment. Its function is to replace joint components, not to identify or diagnose a disease or condition.
No
The device description clearly states it is comprised of physical components (GMK Femur Size 7 and GMK Revision extension stems) and is designed for cemented use in total knee arthroplasty, indicating a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a knee prosthesis, which is an implantable medical device used to replace a damaged knee joint. Its intended use is for surgical implantation in patients with severe knee problems.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any specimens from the human body.
- Focus on Mechanical Function: The description and performance studies focus on the mechanical properties, strength, and fit of the implant within the body.
Therefore, based on the provided information, 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.
The 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.
Product codes
JWH
Device Description
The GMK - Line Extension is comprised of the GMK Femur Size 7 and the GMK Revision extension stems.
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)
A review of the mechanical data indicates that the GMK - Line Extension is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure.
The modification to the GMK system to include the addition of the GMK Femur Size 7 and the GMK Revision extension stems 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 pre-defined 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 conducted on the worst case component size and option/design based on engineering analysis.
The GMK Femur Size 7 was compared to the GMK Femur Size 1 (worst case) in terms of volume for cement insertion, contact surface area, risk of dislocation, and mechanical strength. The GMK Femur Size 7 has a larger volume for cement insertion which reduces the risk of loosening of cement fixation. The GMK Femur Size 7 also has a larger contact surface area which reduces the contact stress between the tibial insert and the femoral component. The GMK Femur Size 7 has an adequate level of constraint to prevent dislocation because of the larger thickness and contact area as compared to the worst case. The GMK Femur Size 7 also has greater mechanical strength than the worst case.
The GMK Revision extension stems were tested and an analysis was performed to identify the worst cases compared to the modified devices. Endurance property testing was conducted to applied standards per FDA guidance "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis; Guidance for Industry and FDA", issued on Jan. 16, 2003. The GMK Revision extension stems met all of the requirements according to the FDA Guidance document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090988, K081023, K102437, K103170
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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JUN - 8 2012
International
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
03/08/2012 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: GMK - Line Extension Common Name: Total Knee Prosthesis Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/Metal/Polymer
21 CFR 888.3560 Class II Device Product Codes: JWH
Predicate Devices:
K090988 GMK Total Knee System (Medacta International) K081023 Evolis Total Knee System (Medacta International) K102437 GMK Total Knee System - Revision (Medacta International) K103170 GMK Revision SC Liners (Medacta International)
GMK - Line Extension 510(k)
Section 5 - Page 2 of 4
1
The GMK - Line Extension is comprised of the GMK Femur Size 7 and the GMK Revision extension stems.
Indications for Use
Product Description
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.
Comparison to Predicate Devices
The GMK - Line Extension has the same intended use, material, and performance characteristics as the predicate devices.
Performance Testing
A review of the mechanical data indicates that the GMK - Line Extension is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure.
The modification to the GMK system to include the addition of the GMK Femur Size 7 and the GMK Revision extension stems 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 pre-defined 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 conducted on the worst case component size and option/design based on engineering analysis.
Section 5 - Page 3 of 4
2
Page 3/3
The GMK Femur Size 7 was compared to the GMK Femur Size 1 (worst case) in terms of volume for cement insertion, contact surface area, risk of dislocation, and mechanical strength. The GMK Femur Size 7 has a larger volume for cement insertion which reduces the risk of loosening of cement fixation. The GMK Femur Size 7 also has a larger contact surface area which reduces the contact stress between the tibial insert and the femoral component. The GMK Femur Size 7 has an adequate level of constraint to prevent dislocation because of the larger thickness and contact area as compared to the worst case. The GMK Femur Size 7 also has greater mechanical strength than the worst case.
The GMK Revision extension stems were tested and an analysis was performed to identify the worst cases compared to the modified devices. Endurance property testing was conducted to applied standards per FDA guidance "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis; Guidance for Industry and FDA", issued on Jan. 16, 2003. The GMK Revision extension stems met all of the requirements according to the FDA Guidance document.
Conclusion:
Based on the above information, the GMK - Line Extension can be considered as substantially equivalent to its predicate devices.
GMK - Line Extension 510(k)
Section 5 - Page 4 of 4
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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 4725 Calle Quetzal, Unit B Camarillo, California, 93012
JUN - 8 2012
Re: K120790
Trade/Device Name: GMK Line Extension Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer, semiconstrained cemented prosthesis
Regulatory Class: Class II Product Code: JWH Dated: May 9, 2012 Received: May 10, 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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Adam Gross
forth in the quality systems (QS) 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,
Evin L. Keith
for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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Indications for Use
510(k) Number (if known):
K 120790
Device Name: GMK - Line Extension
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.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120790
Prescription Use (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)
GMK - Line Extension 510(k) March 13, 2012
Section 4 - Page 2 of 2