← Product Code [MBH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH) · K051510

# SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM (K051510)

_Signal Medical Corp. · MBH · Mar 22, 2006 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K051510

## Device Facts

- **Applicant:** Signal Medical Corp.
- **Product Code:** [MBH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH.md)
- **Decision Date:** Mar 22, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3565
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K051510](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K051510)

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