(271 days)
Not Found
Not Found
No
The document describes a standard knee implant component made of UHMWPE with a traditional design and fixation methods. There is no mention of any computational or data-driven features that would suggest the use of AI or ML.
Yes
The device is indicated for treating severe knee pain and disability caused by various degenerative bone diseases, and it functions as a patellar replacement.
No
The device is a patellar component for knee replacement, intended for treatment of severe knee pain and disability by surgical implantation, not for diagnosis.
No
The device description clearly states the device is made of Ultra-High-Molecular Weight Polyethylene (UHMWPE) and is a physical implant for knee replacement, indicating it is a hardware device.
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. These tests are performed outside of the body.
- Device Description: The provided text describes a Konstruct Patellar Component, which is a surgical implant designed to replace the patella (kneecap) in patients with severe knee pain and disability. It is made of UHMWPE and is intended for implantation within the body during surgery.
- Intended Use: The intended use is for patellar replacement in patients with various degenerative bone diseases and complications from failed prostheses. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for treatment, not a diagnostic tool used for testing samples.
N/A
Intended Use / Indications for Use
The Konstruct Patellar Component is indicated for patients suffering from severe knee pain and disability. Specific indications include patellar replacement in patients who require implantation due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, pseudo-gout or complications from a failed prosthesis.
The device is for use with bone cement only and for fixation by means o of suture supplemental attached. Supplemental suture attachment is used in cases where soft tissues (tendons, ligaments) have ruptured or require reattachment.
Product codes
888.3560
Device Description
This component is made of Ultra-High-Molecular Weight Polyethylene (UHMWPE), a material commonly used for this type of implant. The Konstruct patella is designed for cemented use. The dome shaped topography is a standard design and is compatible with the TC-IV and Performance Total Knee Systems which received marketing clearance in 1986 and 1988, respectively.
The implants are of a uniform 9 mm thickness and have suture holes that allow for fixation supplemental to the standard acrylic fixation if necessary. The partially drilled suture holes surround the component's periphery and grooves in the articular surface allow the sutures to be countersunk so as not to contact the femoral surface. The addition of partially drilled suture holes does not effect the functioning of this device in total knee arthroplasty. What it does do is provide a mechanism for reattachment of soft tissue such as tendons or ligaments using standard suturing techniques. The Konstruct Patellar Component allows for treatment of these soft tissue complications without necessity of revising the entire knee replacement.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
AGC Total Knee System Patellar Component (Biomet, Inc., Warsaw, IN), Total Condylar Knee Prosthesis (Howmedica, Inc., Rutherford, NJ)
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
NOV 27 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor : Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Device : Konstruct Patellar Component
Classification Name: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (888.3560)
Intended Use: The Konstruct Patellar Component is indicated for patients suffering from severe knee pain and disability. Specific indications include patellar replacement in patients who require implantation due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, pseudo-gout or complications from a failed prosthesis.
The device is for use with bone cement only and for fixation by means o of suture supplemental attached. Supplemental suture attachment is used in cases where soft tissues (tendons, ligaments) have ruptured or require reattachment.
Device Description:
This component is made of Ultra-High-Molecular Weight Polyethylene (UHMWPE), a material commonly used for this type of implant. The Konstruct patella is designed for cemented use. The dome shaped topography is a standard design and is compatible with the TC-IV and Performance Total Knee Systems which received marketing clearance in 1986 and 1988, respectively.
The implants are of a uniform 9 mm thickness and have suture holes that allow for fixation supplemental to the standard acrylic fixation if necessary. The partially drilled suture holes surround the component's periphery and grooves in the articular surface allow the sutures to be countersunk so as not to contact the femoral surface. The addition of partially drilled suture holes does not effect the functioning of this device in total knee arthroplasty. What it does do is provide a mechanism for reattachment of soft tissue such as tendons or ligaments using standard suturing techniques. The Konstruct Patellar Component allows for treatment of these soft tissue complications without necessity of revising the entire knee replacement.
1
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
| Reaction to the bone cement
Deformity of the joint
Cardiovascular disorders | Blood vessel damage
Soft tissue imbalance
Delayed wound healing | Bone fracture
Infection |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------|
| Fracture of the cement | Metal sensitivity | Hematoma |
| Implant loosening/migration | Fracture of the components | Dislocation |
| Tissue growth failure | Nerve damage | Excessive wear |
Substantial Equivalence: In function and overall design, the Konstruct Patellar Component is equivalent to other knee components on the market. These include:
AGC Total Knee System Patellar Component (Biomet, Inc., Warsaw, IN) Total Condylar Knee Prosthesis (Howmedica, Inc., Rutherford, NJ)