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Biomet 100% Porous Coated Biaxial Total Elbow

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982398

by Biomet, Inc.

Identifiers

510(k) Number
K982398 FDA 510(k)
FDA Product Code
JDC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3150 FDA 510(k)
Regulation Number
888.3150 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Prosthesis, Elbow, Constrained, Cemented, designed to replace the natural elbow joint. It features a 100% porous-coated biaxial hinge mechanism, intended to restore function and stability in severe joint pathologies, including rheumatoid arthritis, degenerative joint disease, avascular necrosis, and post-traumatic deformities. The constrained design provides controlled motion while accommodating revision procedures where prior treatments have failed.

The Biomet 100% Porous Coated Biaxial Total Elbow is supplied as a cemented implant, requiring surgical placement by an orthopedic specialist. It is intended for single-use in sterile conditions and is classified under FDA 510(k) clearance (K982398) as a Class II device under product code JDC. No MRI safety information is specified, and storage conditions are not detailed in the regulatory data. The device was reviewed by the Orthopedic (OR) Advisory Committee and authorized for use in the United States.

Frequently asked questions

What types of severe joint conditions is this elbow prosthesis designed to address?

This device is specifically designed to restore function and stability in severe joint pathologies such as rheumatoid arthritis, degenerative joint disease, avascular necrosis, and post-traumatic deformities of the elbow. Its constrained, biaxial hinge mechanism provides controlled motion, making it suitable for complex cases where prior treatments have failed or revision procedures are required.

Is this elbow prosthesis intended for reuse or single-use, and how should it be handled?

The Biomet 100% Porous Coated Biaxial Total Elbow is intended for single-use only and must be used in sterile conditions. It requires surgical placement by an orthopedic specialist and is supplied as a cemented implant, meaning it is not designed for repeated use or reprocessing.

What regulatory pathway was followed for this device’s approval, and what classification does it hold?

This device was reviewed under the FDA 510(k) clearance process (K982398) and classified as a Class II medical device under product code JDC. It was determined to be *substantially equivalent* to a legally marketed predicate and was authorized for use in the United States after review by the Orthopedic (OR) Advisory Committee.

Are there any specific storage instructions provided for this elbow prosthesis?

The provided regulatory data does not explicitly detail storage conditions for this device. Clinicians or facilities should follow manufacturer-recommended guidelines for handling and storage to ensure sterility and integrity before surgical use.

Does this device have any known limitations regarding MRI compatibility?

The regulatory data does not specify MRI safety information for the Biomet 100% Porous Coated Biaxial Total Elbow. Clinicians should consult the manufacturer’s labeling or technical documentation for MRI-related precautions before imaging patients with this implant.

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: Biomet 100% Porous Coated Biaxial Total Elbow, K982398 - Biomet 100% Porous Coated Biaxial Total..., BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW 510(k) K982398 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K982398 24 fields · synced Sep 20, 2026