(24 days)
Not Found
No
The summary describes a mechanical knee prosthesis component and its material properties and compatibility, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a knee prosthesis, which is designed to replace a damaged joint and restore its function, thus providing a therapeutic benefit to the patient by alleviating pain and disability.
No
The device is a knee prosthesis, specifically a tibial extension stem, designed for total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint. It is an implantable medical device used in treatment, not for diagnosing conditions.
No
The device description clearly states the device is a tibial extension stem made of titanium alloy, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device description: The provided text describes a knee prosthesis, specifically a tibial extension stem, which is an implantable medical device used in surgery to replace a damaged knee joint.
- Intended Use: The intended use is for total knee arthroplasty, a surgical procedure.
- No mention of biological specimens: The description and intended use do not involve the analysis of any biological specimens.
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.
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 (comma separated list FDA assigned to the subject device)
JWH
Device Description
The GMK Short Stem is a tibial extension stem made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy. The GMK Short Stem has a diameter of 11mm and a length of 30mm. The GMK Short Stem is compatible with the tibial baseplates of the GMK Total Knee System (K090988) and the tibial baseplates of the GMK Sphere Total Knee System (K121416).
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 Short Stem is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure. The GMK Short Stem has the same specifications (materials, diameter, and morse taper) as the 65mm GMK tibial extension stem cleared under K090988. Since the modular connection to the GMK tibial baseplate (K090988) is the same, the test performed on the tibial modular connection (K090988) is also applicable to the connection when the GMK Short Stem is used and no further tests are needed to prove substantial equivalence.
The modification to the device system to include the addition of the GMK Short Stem 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 GMK Short Stem was compared to the worst case K090988 GMK Total Knee component in terms of modular connection to the tibial baseplate and it was determined that the GMK Short Stem is 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.
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Image /page/0/Picture/1 description: The image shows the date "DEC 20 2013" in bold, black font. Below the date, the text "Page 1 of 3" is printed, indicating that this is the first page of a three-page document. The text is also in black font.
Image /page/0/Picture/2 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 first letter. Below the word "Medacta" is the word "International" in a smaller font, and to the right of the word 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
Contact Person: 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
November 22, 2013 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: GMK Short Stem 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 |
|---|---|---|---|
| K090988 | GMK Total Knee System | Medacta International | 7/10/2009 |
| K121416 | GMK Sphere | Medacta International | 7/30/2012 |
| K043101 | NexGen | Zimmer | 3/7/2005 |
GMK Short Stem 510(k)
1
Product Description
The GMK Short Stem is a tibial extension stem made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy. The GMK Short Stem has a diameter of 11mm and a length of 30mm. The GMK Short Stem is compatible with the tibial baseplates of the GMK Total Knee System (K090988) and the tibial baseplates of the GMK Sphere Total Knee System (K121416).
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 indications for use, design features and materials of the GMK Short Stem are substantially equivalent to those of the predicate devices. The GMK Short Stem has the same materials, diameter, and morse taper as the GMK 65mm tibial extension stem cleared under K090988 and has a similar length as the tibial extension stem cleared under the Zimmer NexGen predicate device. The safety and effectiveness of the GMK Short Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/0 description: The image contains several small, dark, irregularly shaped spots scattered across a white background. The spots vary in size and are distributed unevenly, with some clustered together and others appearing in isolation. The overall impression is of minor imperfections or blemishes on a clean surface.
Performance Testing
A review of the mechanical data indicates that the GMK Short Stem is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure. The GMK Short Stem has the same specifications (materials, diameter, and morse taper) as the 65mm GMK tibial extension stem cleared under K090988. Since the modular connection to the GMK tibial baseplate (K090988) is the same, the test performed on the tibial modular connection (K090988) is also applicable to the connection when the GMK Short Stem is used and no further tests are needed to prove substantial equivalence.
The modification to the device system to include the addition of the GMK Short Stem 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 GMK Short Stem was compared to the worst case K090988 GMK Total Knee component in terms of modular connection to the tibial baseplate and it was determined that the GMK Short Stem is not worst case.
Conclusion:
Based on the above information, the GMK Short Stem can be considered as substantially equivalent to its predicate devices.
GMK Short Stem 510(k)
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Medacta International SA % Mr. Adam Gross Director of Regulatory, Quality and Compliance 4725 Calle Quetzal, Unit B Camarillo, California 93012
Re: K133630
Trade/Device Name: GMK Short Stem ·············································································································································································· Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 22, 2013 Received: November 26, 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. Iisting 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 (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 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/ResourcesforYou/Industry/default.htm. Also, please note the requlation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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.
Ronald-P: Jean -S for
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): K133630
Device Name: GMK Short Stem
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 × (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)
Elizabeth 👍Frank -S
Division of Orthopedic Devices