(625 days)
Not Found
Not Found
No
The device description focuses on the materials and mechanical design of a knee replacement prosthesis, with no mention of AI/ML or related concepts.
Yes
The device is intended for the relief of pain and restoration of motion due to several joint diseases, which are therapeutic indications. It replaces a damaged or diseased knee joint, thereby treating the condition.
No
The provided text describes a knee replacement device (prosthesis) used to relieve pain and restore motion in diseased or damaged knee joints. It is a surgical implant, not a tool for diagnosing medical conditions.
No
The device description clearly details physical components made of Co-Cr-Mo and polyethylene, indicating 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the device is a total knee prosthesis designed to replace a damaged or diseased knee joint. This is an implantable surgical device, not a device that analyzes biological specimens.
- Intended Use: The intended use is for the relief of pain and restoration of motion due to joint diseases and revisions of failed knee replacements. This is a therapeutic and restorative function performed directly on the patient's body, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the Freeman/Samuelson Knee is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.
Product codes
Not Found
Device Description
The Freeman/Samuelson Knee is a Co-Cr-Mo femoral component. a Co-Cr-Mo backed polyethylene tibial component and a polyethylene patellar component designed to replace a damaged or disease knee joint.
The system features interchangablity between all sizes of components. The femoral component is available with of without a central stem and offers the option of using finned polyethylene pegs or splined titanium pegs for added fixation of the femoral component. The tibial component has a central stem and attached splined pegs. The polyethylene bearing surface is molded to the metal tibial base plate. The all polyethylene patella component has a finned fixation peg. the patella is contoured to provided greater surface contact than traditional domed patellar components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: Freeman/Samuelson Total Knee System
K 943025
MAR 1 3 1996
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (CFR 888.3560)
Device Description: The Freeman/Samuelson Knee is a Co-Cr-Mo femoral component. a Co-Cr-Mo backed polyethylene tibial component and a polyethylene patellar component designed to replace a damaged or disease knee joint. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.
The system features interchangablity between all sizes of components. The femoral component is available with of without a central stem and offers the option of using finned polyethylene pegs or splined titanium pegs for added fixation of the femoral component. The tibial component has a central stem and attached splined pegs. The polyethylene bearing surface is molded to the metal tibial base plate. The all polyethylene patella component has a finned fixation peg. the patella is contoured to provided greater surface contact than traditional domed patellar 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 the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Tissue growth failure
ﺴﺴ
ﻣﺴﻪ
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage
Bone fracture Infection Hematoma Dislocation Excessive wear
Substantial Equivalence: In function and overall design, Biomet's Freeman/Samuelson Total Knee System is equivalent to almost all knee components on the market. These stems include:
AGC 2000 Total Knee Prosthesis (Biomet, Inc., Warsaw, IN) Maxim Knee System (Biomet, Inc., Warsaw, IN) Freeman/Samuelson Total Knee (Depuy, Warsaw, IN) Freeman/Samuelson Mark II Press-fit (Protek, Indianapolis, IN) Freeman/Samuelson Mark II Press-fit (Protek, Indianapolis, IN)
000007