(206 days)
This is the device that the summary is about, not a predicate. There is no K number provided for the predicate devices in the text.
Not Found
No
The 510(k) summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, image processing, or any other elements typically associated with AI/ML in medical devices. The performance studies focus on mechanical testing.
Yes
The device is a knee replacement system used to treat various conditions like arthritis and failed previous knee surgeries, which directly addresses medical conditions and aims to restore function, meeting the definition of a therapeutic device.
No
The device is a knee replacement system used for surgical intervention, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components made from various materials (Co-Cr-Mo, Ti-6Al-4V, C.P. Titanium, UHMW PE) that are part of the Genesis II Revision System. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing or revising a knee joint due to various conditions like arthritis or failed previous surgeries. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device components are described as implants made of materials like Co-Cr-Mo, Ti-6Al-4V, and UHMW PE, designed to be surgically placed within the knee. This is consistent with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
In summary, the Genesis II Revision System is a surgical implant used for treating knee conditions, which falls under the category of a medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Genesis II Revision System is used for primary and revision surgeries with the following indications
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- Rheumatoid arthritis.
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- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
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- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior stabilized knee system is designed for use in patients in primary and 4. revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Genesis II Total Knee System is indicated for use only with cement and is a single use device.
Product codes
JWH
Device Description
The Genesis II Porous Tibial Trays and Revision Knee consists of the following components: Conversion Module with Taper, Distal Femoral Wedge, Stacked Distal Femoral Wedge, Long Stem Extensions, Femoral Flex-Lok Pegs, Porous Titanium Tibial Tray with and without holes, Porous Spiked Titanium Tibial Tray with and without holes, and the All Poly P/S Tibia! Component. The Conversion Module with Taper is manufactured from Co-Cr-Mo. Wedges and Long Stem Extensions are manufactured from Ti-6Al-4V. The tibial trays are manufactured from Ti-6Al-4V with a C.P. Titanium porous coating. The All Poly P/S Tibial Component and the Flex Lok Pegs are manufactured from UHMW PE
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)
Mechanical testing was performed according to the requirements in the knee draft guidance document. Following is a list of the testing that supports the safety and effectiveness for the Genesis II Knee System: device constraint, device contact area, tibial tray fatigue, and porous coating characterization. All of the test results indicate that the Genesis II Knee System is capable of withstanding in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K953274 (This is the device that the summary is about, not a predicate. There is no K number provided for the predicate devices in the text.)
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
K953274
Summary of Safety and Effectiveness Smith & Nephew Richards Inc. Genesis II Knee System
Substantial Equivalent Information
The Genesis II Knee System is similar to the following knee systems:
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- Genesis I Total Knee System Smith & Nephew Richards Inc.
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- NexGen Knee System Zimmer
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- R.F.C. Modular Knee System Johnson & Johnson
- Whiteside Ortholoc II Modular Knee System Wright Medical Technology, Inc. ধ .
- AMK/Coordinate Knee System Depuy રું.
- Advantim Knee System Wright Medical Technology, Inc. 6.
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- Kinemax Plus Stabilizer Knee System Howmedica
- S-ROM Modular Knee System Joint Medical Products 8.
All of the devices listed above are indicated for total knee replacement and are similar in design to the Genesis II Knee System. The safety and effectiveness of the Genesis II Knee System is based on the long history of use of these devices in the market place.
Device Description
The Genesis II Porous Tibial Trays and Revision Knee consists of the following components: Conversion Module with Taper, Distal Femoral Wedge, Stacked Distal Femoral Wedge, Long Stem Extensions, Femoral Flex-Lok Pegs, Porous Titanium Tibial Tray with and without holes, Porous Spiked Titanium Tibial Tray with and without holes, and the All Poly P/S Tibia! Component. The Conversion Module with Taper is manufactured from Co-Cr-Mo. Wedges and Long Stem Extensions are manufactured from Ti-6Al-4V. The tibial trays are manufactured from Ti-6Al-4V with a C.P. Titanium porous coating. The All Poly P/S Tibial Component and the Flex Lok Pegs are manufactured from UHMW PE
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Indications for Use
The Genesis II Revision System is used for primary and revision surgeries with the following indications
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior stabilized knee system is designed for use in patients in primary and 4. revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Genesis II Total Knee System is indicated for use only with cement and is a single use device.
Mechanical Testing
Mechanical testing was performed according to the requirements in the knee draft guidance document. Following is a list of the testing that supports the safety and effectiveness for the Genesis II Knee System: device constraint, device contact area, tibial tray fatigue, and porous coating characterization. All of the test results indicate that the Genesis II Knee System is capable of withstanding in vivo loading without failure.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the seal is a stylized image of three overlapping shapes that resemble an abstract bird or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 1996
Mr. Thomas L. Craig Director, Clinical and Regulatory Affairs Smith & Nephew Richards Inc. 1450 Brooks Road Memphis, TN 38116
Re: K953274 Genesis II Porous Tibial Trays and Revision Knee Components Regulatory Class: II Product Code: JWH Dated: November 6, 1995 Received: November 7, 1995
Dear Mr. Craig:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:
- The thinnest tibial component available is the nominal 1. "9mm" sized component, which has a minimum polyethylene thickness under the condyles of 9.6mm.
- 2 . This device may not be labeled or promoted for non-cemented use.
- 3 . All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
- 4 . Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive
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Page 2 - Mr. Thomas L. Craig
approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice regarding labeling for your device in accordance with 21 CFR Part 801, promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Kimber Richter
Kimber C. Richter, M.D. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health