(56 days)
Not Found
No
The summary describes a mechanical knee prosthesis and its components, with no mention of AI or ML technology.
Yes
The device is a knee prosthesis designed for total knee arthroplasty, which is a medical procedure to replace a damaged knee joint. This procedure is performed to alleviate severe pain and disability caused by conditions such as arthritis, and therefore, it directly contributes to the treatment and improved health of a patient.
No
Explanation: The device is a knee prosthesis designed for total knee arthroplasty, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a modification to a "Total Knee System," which is a physical implant (hardware). The summary discusses mechanical data and physical characteristics like volume and surface area, further 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 describes a surgical implant for replacing a damaged knee joint. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a knee prosthesis component (patella).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
This device falls under the category of a surgical implant or prosthetic 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 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
This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System was designed to include the GMK Resurfacing Patella Size 4.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Patellofemorotibial
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 Resurfacing Patella Size 4 are equivalent to devices currently cleared for use and are capable of withstanding expected in vivo loading without failure.
The modification to the device system to include the addition of the GMK Resurfacing Patella Size 4 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 Resurfacing Patella Size 4 was compared to the GMK Resurfacing Patella Size 1 (worst case) in terms of volume for cement insertion, contact surface area, and risk of dislocation. The GMK Resurfacing Patella Size 4 has a larger volume for cement insertion which reduces the risk of loosening of cement fixation. The GMK Resurfacing Patella Size 4 also has a larger contact surface area which reduces the contact stress between the patella and the femoral component. The GMK Resurfacing Patella Size 4 also has an adequate level of constraint to prevent dislocation because of the larger thickness and contact area as compared to the worst case.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090988, K951987, K102437, K103170, K081023
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.
0
JAN 2 7 2012
Image /page/0/Picture/2 description: The image shows the logo for Medacta International. The logo consists of a stylized graphic element followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is the word "International" in a smaller font, followed by a plus sign.
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
Mr. Adam Gross Contact Person: 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: December 1, 2011
DEVICE INFORMATION
Trade/Proprietary Name: GMK Resurfacing Patella Size 4 Common Name: Resurfacing Patella 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 Intl) K951987 Genesis II (Smith & Nephew) K102437 GMK Total Knee System- Revision (Medacta Intl) K103170 GMK Revision SC Liners (Medacta Intl) K081023 Evolis Total Knee System (Medacta Intl)
GMK Resurfacing Patella Size 4 510(k)
Section 5 - Page 2 of 4
Page 1/3
1
Kii3571
Product Description
This modification to the original Medacta GMK® (Global Medacta Knee) Total This mountoution to the enginen to include the GMK Resurfacing Patella Size 4.
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.
Comparison to Predicate Devices
The GMK Resurfacing Patella Size 4 has the same indications for use, material, design, and performance characteristics as the previously cleared Medacta GMK Resurfacing Patellas (Sizes 1,2,3). The GMK Resurfacing Patella Size 4 is similar to the Smith & Nephew Genesis II Resurfacing patella in terms of indications for use, material, and size.
ﻟﻤﺴﺎﺣﺔ ﻣ
GMK Resurfacing Patella Size 4 510(k)
Section 5 - Page 3 of 4
Page 2/3
2
K11 3571
Performance Testing
A review of the mechanical data indicates that the GMK Resurfacing Patella Size 4 are equivalent to devices currently cleared for use and are capable of withstanding expected in vivo loading without failure.
The modification to the device system to include the addition of the GMK Resurfacing Patella Size 4 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 Resurfacing Patella Size 4 was compared to the GMK Resurfacing Patella Size 1 (worst case) in terms of volume for cement insertion, contact surface area, and risk of dislocation. The GMK Resurfacing Patella Size 4 has a larger volume for cement insertion which reduces the risk of loosening of cement fixation. The GMK Resurfacing Patella Size 4 also has a larger contact surface area which reduces the contact stress between the patella and the femoral component. The GMK Resurfacing Patella Size 4 also has an adequate level of constraint to prevent dislocation because of the larger thickness and contact area as compared to the worst case.
Conclusion:
Based on indications for use, materials, design, and risk verification of volume for cement insertion, contact surface area, and risk of dislocation as compared to the worst case, the GMK Resurfacing Patella Size 4 can be considered as substantially equivalent to the predicate devices.
GMK Resurfacing Patella Size 4 510(k)
Section 5 - Page 4 of 4
Page 3/3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The eagle is depicted in a simple, abstract style, with flowing lines suggesting its feathers and form.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 7 2012
Medacta International % Medacta USA Mr. Adam Gross 4725 Calle Quetzal, Unit B Camarillo, California, 93012
Re: K113571
Trade/Device Name: GMK Resurfacing Patella Size 4 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: December 29, 2011
Received: December 30, 2011
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,
Erinel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K 113571 510(k) Number (if known):
Device Name: GMK Resurfacing Patella, Size 4
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 |
| 510(k) Number | K113571 |
|---|---|
| --------------- | --------- |
GMK Resurfacing Patella Size 4 510(k) November 30, 2011
Section 4 - Page 2 of 2
Page 1/1