(30 days)
Not Found
No
The document describes a mechanical knee replacement system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a knee replacement system intended for total knee replacement due to various degenerative problems, which is a therapeutic intervention.
No
The device, the GENFlex2 Total Knee System, is intended for total knee replacement and revision surgeries due to various degenerative problems. It is a joint replacement system, which functions as a prosthetic to replace damaged anatomical structures rather than to diagnose medical conditions.
No
The device description clearly states it is a total knee joint replacement system comprised of modular components manufactured from materials like polyethylene and cobalt chrome alloy, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "Total knee replacement" and "Revision of failed previous reconstructions." This describes a surgical implant used in the body, not a test performed on samples taken from the body.
- Device Description: The description details "modular components" for a "total knee joint replacement system" made of materials like polyethylene and cobalt chrome alloy. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a prosthetic implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The GENFlex2 Total Knee System is intended for:
Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only.
Product codes
JWH, OIY
Device Description
The GENflex2 System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to modify the geometries of the Posterior Stabilized and the Cruciate Retaining tibial insert and femoral component. These components are manufactured from EXp Vitamin E Polyethylene, Conventional Polyethylene and Cobalt Chrome Alloy. Each component is available in a range of sizes that complement each other.
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
Prescription Use
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
Static and fatigue A/P shear testing and engineering analyses of contact area were performed on the modified components of the GENflex2 Total Knee System and the predicate Proven Total Knee System. All results demonstrate that the modified device performs similarly to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human face in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
StelKast, Incorporated % Mr. David Stumpo Vice President of Product Development 200 Hidden Valley Road McMurray, Pennsylvania 15317
Re: K16222 Trade/Device Name: GENflex2 Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: August 5, 2016 Received: August 8, 2016
Dear Mr. Stumpo:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the
1
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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162222
Device Name GENflex2 Total Knee System
Indications for Use (Describe) The GENFlex2 Total Knee System is intended for:
· Total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis, and/or post-traumatic degenerative problems.
• Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Manufacturer: | StelKast, Inc.
200 Hidden Valley Road
McMurray, PA 15317
Phone: 724.731.2208
Fax: 727.941.5987 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. David Stumpo
Vice President of Product Development |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: 202.552.5800
Fax: 202.552.5798 |
| Date Prepared: | August 31, 2016 |
| Device Trade Name: | GENflex2 Total Knee System |
| Device Common Name: | Total Knee Replacement System |
| Classification: | 21 CFR 888.3560
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis
Class II |
| Product Codes: | JWH, OIY |
| Indications for Use: | The GENFlex2 Total Knee System is intended for:
● Total knee replacement due to osteoarthritis, osteonecrosis
rheumatoid arthritis, and/or post-traumatic degenerative
problems.
● Revision of failed previous reconstructions where
sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only. |
4
Device Description: The GENflex2 System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to modify the geometries of the Posterior Stabilized and the Cruciate Retaining tibial insert and femoral component. These components are manufactured from EXp Vitamin E Polyethylene, Conventional Polyethylene and Cobalt Chrome Alloy. Each component is available in a range of sizes that complement each other.
The modified GENflex2 Total Knee System is substantially Predicate Devices: equivalent to the predicate Proven Total Knee System (K980276, K063211, K122883) with respect to intended use, materials, geometry, range of available sizes, methods of fixation, and performance characteristics. The information summarized in the Design Control Activities Summary demonstrates that the modified geometries of the tibial insert femoral component meet the pre-determined acceptance criteria for the verification activities.
Static and fatigue A/P shear testing and engineering analyses of Substantial Equivalence: contact area were performed on the modified components of the GENflex2 Total Knee System and the predicate Proven Total Knee System. All results demonstrate that the modified device performs similarly to the predicate device.
Limulus Amebocyte Lysate *NCN+'testing was performed on the GENflex2 implants to establish thev'y g'f gxleg"o ggw'r { tqi gp'rlo ki' specifications.