K943025 · Biomet, Inc. · JWH · Mar 13, 1996 · Orthopedic
Device Facts
Record ID
K943025
Device Name
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
Applicant
Biomet, Inc.
Product Code
JWH · Orthopedic
Decision Date
Mar 13, 1996
Decision
SN
Submission Type
Traditional
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
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.
Device Story
Total knee replacement system; replaces damaged/diseased knee joints. Components: Co-Cr-Mo femoral component (with/without central stem; finned polyethylene or splined titanium pegs); Co-Cr-Mo backed polyethylene tibial component (central stem, splined pegs); polyethylene patellar component (finned fixation peg, contoured surface). Used in orthopedic surgery; implanted by surgeons. Provides pain relief and restored motion. Fixation via bone cement.
Indicated for patients requiring knee joint replacement due to non-inflammatory degenerative joint disease, rheumatoid arthritis, knee deformities, or revision of failed prior knee replacements. Intended for use with bone cement.
Regulatory Classification
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).
Predicate Devices
AGC 2000 Total Knee Prosthesis (Biomet, Inc.)
Maxim Knee System (Biomet, Inc.)
Freeman/Samuelson Total Knee (Depuy)
Freeman/Samuelson Mark II Press-fit (Protek)
Submission Summary (Full Text)
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Summary of Safety and Effectiveness
Sponsor: Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0578
K 943025
Device: Freeman/Samuelson Total Knee System
MAR 13 1996
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained 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 interchangability between all sizes of components. The femoral component is available with or 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 | Blood vessel damage | Bone fracture |
| --- | --- | --- |
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disorders | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Fracture of the components | Excessive wear |
| Tissue growth failure | Nerve damage | |
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)
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