SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM
Device Facts
| Record ID | K051510 |
|---|---|
| Device Name | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM |
| Applicant | Signal Medical Corp. |
| Product Code | MBH · Orthopedic |
| Decision Date | Mar 22, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3565 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
