(29 days)
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No
The document describes a mechanical knee implant and its components, with no mention of AI or ML in its function, design, or testing.
Yes
The device is a total knee replacement system, which is used to treat medical conditions like osteoarthritis and rheumatoid arthritis, making it a therapeutic device.
No
The device is a total knee replacement system, which is an implantable medical device used for treatment, not diagnosis.
No
The device description clearly states it is a "Total Knee System" and describes physical components like a "Tibial Insert" made from "Polyethylene," indicating it is a hardware medical device.
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 replacement and revision of failed reconstructions. This is a surgical procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a component of a total knee joint replacement system, which is an implantable medical device.
- Lack of Diagnostic Activity: There is no mention of the device being used to diagnose a condition, analyze biological samples, or provide information about a patient's health status through testing of samples.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. 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 osteoardis, 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY
Device Description
The purpose of this Special 510(k) is to add the Ultra-Congruent CR Tibial Insert to the GENFlex2 Total Knee System. The Ultra-Congruent CR Tibial Insert is a component within a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The articulating geometry of the Ultra-Congruent CR Tibial Insert provides for increased stability relative to the predicate CR insert. The inserts are manufactured from EXp Vitamin E Polyethylene and Conventional Polyethylene.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee Joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A/P constraint testing was performed on the modified GENFlex2 Ultra-Congruent CR Tibial Inserts and compared to results for the predicate inserts. Contact area analyses were performed on the modified and predicate devices. All results demonstrate that the modified device performs similarly to the predicate device.
Limulus Amebocyte Lysate (LAL) testing was performed on the implants to establish that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K162222, K980276, K063211, K122883
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.
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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).
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§ 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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 19, 2018
StelKast, Inc. % Hollace Rhodes Senior Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K173875
Trade/Device Name: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert 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: December 20, 2017 Received: December 21, 2017
Dear Hollace Rhodes:
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
1
801); medical device 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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)
Device Name
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
Indications for Use (Describe)
The GENFlex2 Total Knee System is intended for:
· Total knee replacement due to osteoardis, 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) |
|---|
| ------------------------------------------------- |
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
1050 K Street NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | December 20, 2017 |
| Device Trade Name: | GENFlex2 Total Knee System – Ultra-Congruent CR Tibial
Insert |
| 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 purpose of this Special 510(k) is to add the Ultra-Congruent CR Tibial Insert to the GENFlex2 Total Knee System. The Ultra-Congruent CR Tibial Insert is a component within a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The articulating geometry of the Ultra-Congruent CR Tibial Insert provides for increased stability relative to the predicate CR insert. The inserts are manufactured from EXp Vitamin E Polyethylene and Conventional Polyethylene.
- The GENFlex2 Ultra-Congruent CR Tibial Insert is Predicate Devices: substantially equivalent to the predicate inserts of the GENFlex2 Total Knee System (K162222), originally cleared as the Proven Total Knee System (K980276, K063211, and K122883) with respect to intended use, materials, design, range of available sizes, method of fixation, and performance characteristics. The information summarized in the Design Control Activities Summary demonstrates that the modified geometry of the Ultra-Congruent CR Tibial Insert meets the pre-determined acceptance criteria for the verification activities.
- A/P constraint testing was performed on the modified Substantial GENFlex2 Ultra-Congruent CR Tibial Inserts and compared Equivalence: to results for the predicate inserts. Contact area analyses were performed on the modified and predicate devices. All results demonstrate that the modified device performs similarly to the predicate device.
Limulus Amebocyte Lysate (LAL) testing was performed on the implants to establish that the device meets pyrogen limit specifications.