(368 days)
No
The device description focuses on the materials, design, and manufacturing processes of the knee replacement components. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
No
The device is a total knee replacement system, which is a prosthetic replacement for the knee joint, not a therapeutic device used for treatment or therapy.
No
Explanation: The device described is a total knee replacement system, which is an implantable medical device used for treatment (replacing a damaged knee joint), not for diagnosing a condition.
No
The device description clearly details physical components made of cobalt chromium, titanium, and UHMWPE, which are implanted into the patient. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee prosthesis (femoral component, tibial component, patellar component, etc.) and their materials. This aligns with a medical device intended for implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The device is used directly on the knee joint, which is consistent with a surgical implant.
- Predicate Devices: The predicate devices listed are also total knee replacement systems, further confirming the device's nature as a surgical implant.
IVD devices are used outside the body to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include ternoral, titbial and patellar replacement in a wide size range of 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 of the femoral condyle, pseudo-gout or complications from a falled prosthesis.
Product codes
Not Found
Device Description
The Kirschner Knee Modified encompasses the Kirschner Performance Total Knee System, Kirschner TC-IV Total Condylar Knee System and Kirschner HybridFit Total Knee.
Kirschner Performance Total Knee System features an anatomically designed cast cobalt chromium femoral component whose geometry allows for maximum range of motion and size interchangeability. It comes with a non-porous coated proximal supracondylar flange and two non-porous coated fixation pegs to minimize stress shielding and permit compression between the porous coated surface and bone. Five sizes in left/right anatomic configurations are available to better match the patient's anatomy. The modular titanium tibial component has four screw holes and comes with either a cruciate or round Available is an all polv tibial component. There are femoral and tibial stem. augmentations to fill cavitary defects.
Kirschner TC-IV Total Condylar Knee Svstem features a cobalt chromium femoral component with a "waffled" non-porous coated proximal flange and two non-porous fixation peas. The one-piece cobalt chromium tibled component has a posterior recess allowing for the retention of the posterior cruciate ligament.
The UHMWPE patellar component for both the Performance and TC-IV knee systems come in porous-coated metal-backed or all UHMWPE options.
The HybridFit cobalt chrome tibial tray accepts the TC-IV or Performance bearing inserts and can be used with either the Performance or the TC-IV femoral component.
These knee devices are intended for use with bone cement.
The major changes are in material and method of the porous coating and in the manufacturing process of the Ultra High Molecular Weight Polyethylene.
Porous coated Kirschner Knees Modified features plasma spray coating of titanium alloy powder. The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure.
The polyethylene components are of ArCom UHMWPE, Biomet's improved polyethylene components.
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)
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
MAR 1 7 1997
Summary of Safety and Effectiveness
Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: Kirschner® Knee Modified
Knee joint patellofemerotibial polymer/metal/polymer semi-Classification Name: constrained cemented prosthesis (CFR 888.3560).
Indications For Use: Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include ternoral, titbial and patellar replacement in a wide size range of 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 of the femoral condyle, pseudo-gout or complications from a falled prosthesis.
The Kirschner Knee Modified encompasses the Kirschner Device Description: Performance Total Knee System, Kirschner TC-IV Total Condylar Knee System and Kirschner HybridFit Total Knee.
Kirschner Performance Total Knee System features an anatomically designed cast cobalt chromium femoral component whose geometry allows for maximum range of motion and size interchangeability. It comes with a non-porous coated proximal supracondylar flange and two non-porous coated fixation pegs to minimize stress shielding and permit compression between the porous coated surface and bone. Five sizes in left/right anatomic configurations are available to better match the patient's anatomy. The modular titanium tibial component has four screw holes and comes with either a cruciate or round Available is an all polv tibial component. There are femoral and tibial stem. augmentations to fill cavitary defects.
Kirschner TC-IV Total Condylar Knee Svstem features a cobalt chromium femoral component with a "waffled" non-porous coated proximal flange and two non-porous fixation peas. The one-piece cobalt chromium tibled component has a posterior recess allowing for the retention of the posterior cruciate ligament.
The UHMWPE patellar component for both the Performance and TC-IV knee systems come in porous-coated metal-backed or all UHMWPE options.
1
The HybridFit cobalt chrome tibial tray accepts the TC-IV or Performance bearing inserts and can be used with either the Performance or the TC-IV femoral component.
These knee devices are intended for use with bone cement.
The major changes are in material and method of the porous coating and in the manufacturing process of the Ultra High Molecular Weight Polyethylene.
Porous coated Kirschner Knees Modified features plasma spray coating of titanium alloy powder. The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure.
The polyethylene components are of ArCom UHMWPE, Biomet's improved polyethylene components.
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 bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Fracture of the components Blood vessel damage Soft tissue imbalance Delaved wound healing Metal sensitivitv Tissue growth failure Nerve damage
Bone Fracture Infection Hematoma Dislocation Excessive wear
Substantial Equivalence: In function and overall design, Biomet's Kirschner Knee Modified knee components are equivalent to almost any knee components on the market, includina:
Maxim Total Knee System (Biomet, Inc.) 510(k)# K915132 cleared for market 2/11/92.
AGC 2000 Total Knee Prosthesis (Biomet. Inc.) 510(k)# K833921 cleared for market 1/31/84.