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Beacon Knee System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051510

by Signal Medical Corp.

Identifiers

510(k) Number
K051510 FDA 510(k)
FDA Product Code
MBH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3565 FDA 510(k)
Regulation Number
888.3565 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Beacon Knee System is a metal/polymer porous-coated uncemented knee prosthesis designed as a total knee replacement. It is classified as a knee joint patellofemorotibial device, intended to restore function by replacing a damaged knee joint while limiting translation and rotation through its articulating surface geometry.

This device is supplied as an orthopedic implant and is intended for surgical use in a hospital or clinical setting. It is intended for single-use and is not sterilised for reuse. The system is regulated under FDA 510(k) clearance (K051510) with a product code of MBH, classified under the Orthopedic advisory committee. No additional sterility or MRI safety information is provided in the specifications.

Frequently asked questions

What types of knee damage is the Beacon Knee System designed to address and how does it work?

The Beacon Knee System is designed as a total knee replacement to restore function in patients with damaged knee joints. It replaces the knee joint by providing a porous-coated, uncemented prosthesis made of metal and polymer. The system limits translation and rotation through its articulating surface geometry, helping to stabilize the knee and improve mobility for patients with degenerative joint conditions or trauma.

Is the Beacon Knee System intended for reuse in the same patient, or is it meant to be used only once?

The Beacon Knee System is explicitly intended for single-use only and is not sterilized for reuse. This is a standard practice for orthopedic implants to ensure patient safety and prevent cross-contamination in surgical settings.

What surgical setting is appropriate for implanting the Beacon Knee System, and what type of facility should perform the procedure?

The Beacon Knee System is designed for surgical use in a hospital or clinical setting where total knee arthroplasty can be performed under controlled conditions. It requires specialized orthopedic surgeons and operating room facilities equipped to handle joint replacement procedures.

What materials are used in the Beacon Knee System, and how does the porous coating contribute to its function?

The Beacon Knee System combines metal and polymer materials in its construction, with a porous coating applied to the prosthesis. This porous design promotes osseointegration, allowing the implant to bond directly with the patient’s bone over time, which enhances stability and longevity compared to traditional cemented implants.

How is the Beacon Knee System regulated in the U.S., and what does the product code (MBH) signify?

The Beacon Knee System has received FDA 510(k) clearance under the product code MBH, which classifies it as a knee joint patellofemorotibial device under the Orthopedic advisory committee (OR). This clearance indicates it is deemed *substantially equivalent* to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness as a total knee replacement.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Signal Medical Corporation Beacon Knee System, Signal Medical Corp. FDA 510 (k) Products (1997-2011), SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM 510(k) K051510 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Signal Medical Corp.

Sources (1)

  • FDA 510(k) K051510 24 fields · synced Oct 6, 2026