(105 days)
No
The document describes a knee prosthesis and its components, focusing on materials, sizes, and mechanical performance. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is a knee prosthesis designed to replace a severely painful and/or disabled joint, which directly treats a medical condition.
No
The device is a knee prosthesis, which is a surgical implant used for total knee arthroplasty, not for diagnosing medical conditions.
No
The device description explicitly lists physical implants made of materials like Co-Cr-Mo, UHMWPE, and Ti6Al4V, which are hardware components of a knee prosthesis.
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 replacing a knee joint due to various conditions like arthritis and trauma. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a knee prosthesis system made of materials like Co-Cr-Mo and UHMWPE, which are typical for orthopedic implants.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to restore function to a damaged joint.
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 condvle.
· Post traumatic loss of joint configuration.
· Primary implantation failure.
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.
In case a GMK Revision tibial tray is used, an extension stem must be implanted.
Product codes
JWH
Device Description
The GMK Sphere Total Knee System allows for medial-pivot rotation of the knee joint. The GMK Sphere Extension is a line extension to the GMK Sphere Total Knee System and is comprised of the following implants:
- . Femoral Component Left and Right, Sizes 1+ to 6+ (intermediate sizes) Co-Cr-Mo (ISO 5832-4)
- Tibial Insert Fixed Flex, Left and Right, Sizes 1-6, 11mm and 13mm . (intermediate sizes)
UHMWPE (ISO 5834 -2) Type 1, Ti6Al4V (ISO 5232-3)
The following components of the GMK Sphere have been previously cleared under the K121416 predicate device:
- · Femoral Component Left and Right, Sizes 1-7 Co-Cr-Mo (ISO 5832-4)
- Tibial tray fixed cemented Left and Right, 4 intermediate sizes . Co-Cr-Mo (ISO 5832-4)
- Tibial Insert Fixed Flex and Congruent, Left and Right, Sizes 1-6, 10mm-20mm . UHMWPE (ISO 5834 -2) Type 1, Ti6AI4V (ISO 5232-3)
The following components of the GMK Sphere have been previously cleared under the Medacta GMK Total Knee System, which is the primary predicate to K121416 GMK Sphere:
- . Resurfacing patella Sizes 1-4 (K090988 and K113571)
- Tibial tray fixed cemented Left and Right, Sizes 1-6 (K090988) .
- Primary extension stem Ø11mm / L 65 mm (K090988) and L 30mm (K133630) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 modification to the device system to include the addition of the GMK Sphere Extension 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 Sphere Extension was compared to the worst case predicate device in terms of fatigue, wear, constraints, clipping system, and range of motion and it was determined that the GMK Sphere Extension 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.
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
JUL 1 5 2014
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of a stylized graphic element above the word "Medacta", with a horizontal line separating it from the word "International" below. To the right of "International" is a symbol resembling 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 1556 W Carroll Ave Chicago, IL 60607 Phone: (805) 910-6511 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: March 28, 2013
DEVICE INFORMATION .
Trade/Proprietary Name: GMK Sphere Extension Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. 21 CFR 888.3560 Class II Product Code(s): JWH
Predicate Devices:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K121416 | GMK Sphere | Medacta International | 7/30/2012 |
| K090988 | GMK Total Knee System | Medacta International | 7/10/2009 |
GMK Sphere Extension 510(k)
Section 5 - Page 2 of 4
1
Product Description
The GMK Sphere Total Knee System allows for medial-pivot rotation of the knee joint. The GMK Sphere Extension is a line extension to the GMK Sphere Total Knee System and is comprised of the following implants:
- . Femoral Component Left and Right, Sizes 1+ to 6+ (intermediate sizes) Co-Cr-Mo (ISO 5832-4)
- Tibial Insert Fixed Flex, Left and Right, Sizes 1-6, 11mm and 13mm . (intermediate sizes)
UHMWPE (ISO 5834 -2) Type 1, Ti6Al4V (ISO 5232-3)
The following components of the GMK Sphere have been previously cleared under the K121416 predicate device:
- · Femoral Component Left and Right, Sizes 1-7 Co-Cr-Mo (ISO 5832-4)
- Tibial tray fixed cemented Left and Right, 4 intermediate sizes . Co-Cr-Mo (ISO 5832-4)
- Tibial Insert Fixed Flex and Congruent, Left and Right, Sizes 1-6, 10mm-20mm . UHMWPE (ISO 5834 -2) Type 1, Ti6AI4V (ISO 5232-3)
The following components of the GMK Sphere have been previously cleared under the Medacta GMK Total Knee System, which is the primary predicate to K121416 GMK Sphere:
- . Resurfacing patella Sizes 1-4 (K090988 and K113571)
- Tibial tray fixed cemented Left and Right, Sizes 1-6 (K090988) .
- Primary extension stem Ø11mm / L 65 mm (K090988) and L 30mm (K133630) .
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 condvle.
- · Post traumatic loss of joint configuration.
· Primary implantation failure.
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on
the tibial and on the femoral components.
In case a GMK Revision tibial tray is used, an extension stem must be implanted.
GMK Sphere Extension 510(k)
Section 5 - Page 3 of 4
2
Comparison to Predicate Devices
The indications for use, design features and materials of the GMK Sphere Extension are substantially equivalent to those of the predicate devices. The substantial equivalence of the GMK Sphere Extension implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.
Performance Testing
The modification to the device system to include the addition of the GMK Sphere Extension 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 Sphere Extension was compared to the worst case predicate device in terms of fatigue, wear, constraints, clipping system, and range of motion and it was determined that the GMK Sphere Extension is not worst case.
Conclusion:
Based on the above information, the GMK Sphere Extension can be considered as substantially equivalent to its predicate devices.
3
DEPARTMENT OF HEALTII & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/3/Picture/3 description: The image shows a partial view of a logo or emblem. The visible portion includes the text 'DEPARTMENT OF HEALTH & HUM', arranged in a circular fashion, suggesting the complete text forms a ring around a central image. To the right of the text, there is a stylized graphic that appears to be a simplified representation of a human figure or a symbol related to health. The overall design suggests an official seal or emblem, likely associated with a health department or organization.
July 15, 2014
Medacta International Mr. Adam Gross Director of Regulatory, Quality and Compliance 1556 West Carroll Avenue Chicago, Illinois 60607
Re: K140826
Trade/Device Name: GMK Sphere Extension Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Class: Class II Product Code: JWH Dated: April 15, 2014
Received: April 16, 2014
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 (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 Industry and Consumer Education at its toll-free 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 regulation 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiqqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF KEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0810-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K140826
Device Name GMK Sphere Extension
Indications for Use (Describe)
The GMK knee prosthesis is designed for commod use in total knee antrophasy, if there is cridence of sufficient sound bone to see end support the components.
This knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of adhritis, treumatic arthritis or polyartiritis or polyartiritis.
· Avascular necrosis of femoral condyle.
· Post traumatic loss of joint configuration.
Type of Use (Select one or both, as applicable)
· Primary implantation failure.
Tibial wedges ocmented are to be attached to the tibis! baseplate with bath the fixing cylinders and bone centers. The screwed ubial nugments are for screwed fixation to the tibial baseptate.
In case a semi-constrained liner is used, an oxtension stam must be implanted both on the formal companses. In case a GMK Revision tibial tray is used, an extension stem must be implanted.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
| Page 1/1 |
|---|
| ---------- |
FORM FDA 3881 (1/14)
GMK Sphere Extension 510(k) March 30, 2014
Section 4 - Page 2 of 3