(60 days)
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No
The document describes a mechanical knee implant system with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is indicated for treating conditions like rheumatoid arthritis and osteoarthritis, which are therapeutic uses.
No
The provided text describes a medical device, the Genesis II Constrained System, which is a knee implant used in surgical procedures. Its intended use is to treat various types of arthritis and failed knee replacements. It is a therapy device that replaces a dysfunctional body part, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly states that the Genesis II Constrained System consists of physical components (femoral component and tibial insert) made of specific materials (cobalt-chromium-molybdenum and ultra-high-molecular-weight polyethylene). This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Genesis II Constrained System is described as a femoral component and a tibial insert made of metal and plastic. These are components of a knee replacement system.
- Intended Use: The intended use is for surgical implantation to replace a damaged knee joint. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgically implanted medical device used to treat knee conditions, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Genesis II Constrained System is indicated for:
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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 Genesis II Constrained System is designed for use in patients in primary and revision 4. surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
The Genesis II Constrained System is indicated for use with cement and is a single use device.
Product codes
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Device Description
The Genesis II Constrained System consists of a femoral component and a tibial insert. The femoral component is manufactured from cobalt-chromium-molybdenum and the tibial insert is manufactured from ultra-high-molecular-weight polyethylene. The femoral component has a boxlike design that mates with a post on the tibial insert to constrain motion.
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
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Indicated Patient Age Range
older patients
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)
Mechanical testing was performed according to the requirements in the knee draft guidance document. All of the test results indicate that the Genesis II Constrained System is capable of withstanding in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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
Summary of Safety and Effectiveness Smith & Nephew Richards Inc. Genesis II Constrained System
AUG - 2 1996
Substantial Equivalence Information
The Genesis II Constrained System is similar to the following knee systems
- Genesis Constrained Knee System Smith & Nephew Richards 1.
- Genesis II Knee System Smith & Nephew Richards 2.
- Genesis I P/S Knee Systems Smith & Nephew Richards 3.
- Insall/Burstein Constrained Condylar Knee Zimmer 4.
- P.F.C. Modular Knee System Johnson & Johnson 5.
- Omnifit Total Knee System Osteonics 6.
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- Coordinate Revision Knee System - Depuy
All of the devices listed above are similar in design to the Genesis II Constrained System. The safety and effectiveness of the Genesis II Constrained System is based on the long history of use of these devices in the market place.
Device Description
The Genesis II Constrained System consists of a femoral component and a tibial insert. The femoral component is manufactured from cobalt-chromium-molybdenum and the tibial insert is manufactured from ultra-high-molecular-weight polyethylene. The femoral component has a boxlike design that mates with a post on the tibial insert to constrain motion.
Indications for Use
The Genesis II Constrained System is indicated for:
-
- 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 Genesis II Constrained System is designed for use in patients in primary and revision 4. surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
The Genesis II Constrained System is indicated for use with cement and is a single use device.
Mechanical Testing
Mechanical testing was performed according to the requirements in the knee draft guidance document. All of the test results indicate that the Genesis II Constrained System is capable of withstanding in vivo loading without failure.