(107 days)
Not Found
No
The description focuses on the mechanical properties and materials of a knee implant, with no mention of AI or ML capabilities.
Yes
The device is a total knee replacement system, which is explicitly described as designed to alleviate pain and disability resulting from various joint conditions. Its purpose is to restore joint configuration and mobility, directly treating a medical condition.
No
This device is a total knee system, which is an implantable medical device used in knee replacement surgery. Its purpose is to replace damaged knee joints, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant made of UHMWPE and AISI 316 LVM, designed for surgical implantation in the knee joint. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint with artificial parts. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant (tibial component) made of UHMWPE and metal wires. It is designed to be surgically implanted into the knee joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a medical device, specifically a prosthetic implant, used in a surgical setting.
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. .
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The GMK Full PE Tibial Components are symmetric and come in ultracongruent and posterior-stabilized designs in sizes 1-6 with thicknesses of 10, 12, 14, and 17mm and have an axial rotation of +/- 10°. The GMK Full PE Tibial Components are made from UHMWPE (ISO 5834 -2) Type 1. There are two radiopaque wires made of AISI 316 LVM (ISO 5832-1) to check the final implant position during radiography. The GMK Full PE Tibial Components can be used in place of the metal backed solution (K090988), where a component entirely made of UHMWPE replaces the metal backed solution (metallic tibial tray + UHMWPE tibial insert, K090988).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiography
Anatomical Site
Knee joint
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)
The GMK Full PE Tibial Components was tested for the following compared to the predicate devices:
- Breakage .
- Implant detachment .
- Excessive wear of the articulating surface .
- Femoral luxation or subluxation due to insufficient constraints .
- Insufficient mobility and/or Range of Motion (ROM) according to ASTM 2083 .
A review of the mechanical data indicates that the GMK Full PE Tibial Components is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure.
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.
K951987, K953274, K090988, K113571, K120790, K122232, K081023, K991581, K042271, K070214
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
K131310 (1/3)
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 triangles above the "M". Below the word "Medacta" is the word "International" in a smaller font. To the right of the word "International" is a symbol that looks like 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
AUG 2 2 2013
Contact Person: Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805) 322-3289 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: April 25, 2013
DEVICE INFORMATION
Trade/Proprietary Name: GMK Full PE Tibial Components 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: | |||
|---|---|---|---|
| 510(k) | Product | 510(k) Holder | Clearance Date |
| K951987 | Genesis II CR | Smith and Nephew, Inc. | 08/22/1995 |
| K953274 | Genesis II PS | Smith and Nephew, Inc. | 02/05/1996 |
| K090988, K113571, | |||
| K120790, K122232 | GMK Total Knee | ||
| System | Medacta International | 7/10/2009,1/27/2012, | |
| 6/8/2012, 9/28/2012 | |||
| K081023 | Evolis Total Knee | ||
| System | Medacta International | 10/22/2008 | |
| K991581, K042271 | NexGen LPS | Zimmer | 7/30/1999, 10/13/2004 |
| K070214 | Natural Knee | Zimmer | 3/16/2007 |
1
Product Description
The GMK Full PE Tibial Components are symmetric and come in ultracongruent and posterior-stabilized designs in sizes 1-6 with thicknesses of 10, 12, 14, and 17mm and have an axial rotation of +/- 10°. The GMK Full PE Tibial Components are made from UHMWPE (ISO 5834 -2) Type 1. There are two radiopaque wires made of AISI 316 LVM (ISO 5832-1) to check the final implant position during radiography. The GMK Full PE Tibial Components can be used in place of the metal backed solution (K090988), where a component entirely made of UHMWPE replaces the metal backed solution (metallic tibial tray + UHMWPE tibial insert, K090988).
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 confiquration. .
- . Primary implantation failure.
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.
Comparison to Predicate Devices
The indications for use, design features, and materials of the subject device are substantially equivalent to those of the predicate devices. The design features of both the GMK Full PE Tibial Components and the predicates come in ultracongruent and posterior-stabilized designs in similar sizes and thicknesses. The GMK Full PE Tibial Components and the predicates are both made of UHMWPE (ISO 5834 -2) Type 1 and can be used in place of the metal backed solution (metallic tibial tray + UHMWPE tibial insert).
The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the GMK Full PE Tibial Components are adequately supported by the substantial equivalence information. materials information, and analysis data provided within this Premarket Notification.
2
Performance Testing
The GMK Full PE Tibial Components was tested for the following compared to the predicate devices:
- Breakage .
- Implant detachment .
- Excessive wear of the articulating surface .
- Femoral luxation or subluxation due to insufficient constraints .
- Insufficient mobility and/or Range of Motion (ROM) according to ASTM 2083 .
A review of the mechanical data indicates that the GMK Full PE Tibial Components is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure.
Conclusion:
Based on the above information, the GMK Full PE Tibial Components 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Medacta International SA % Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, California 93012
Re: K131310
Trade/Device Name: GMK Full PE Tibial Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 2, 2013 Received: July 3, 2013
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
4
Page 2 - Mr. Adam Gross
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. 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 vours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131310
Device Name: GMK Full PE Tibial Components
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. .
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.
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)
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GMK Full PE Tibial Components 510(k) May 3, 2013
Section 4 - Page 2 of 2