(271 days)
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.
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.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a summary of safety and effectiveness for a medical device (Konstruct Patellar Component) and focuses on its description, intended use, potential risks, and substantial equivalence to other devices on the market. It does not include details about device performance metrics, study designs, sample sizes, expert involvement, or ground truth establishment.
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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.
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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 cementDeformity of the jointCardiovascular disorders | Blood vessel damageSoft tissue imbalanceDelayed wound healing | Bone fractureInfection |
|---|---|---|
| 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)
§ 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.