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Biomet Oncology Salvage System Taper Stacking Adapter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011455

by Biomet, Inc.

Identifiers

510(k) Number
K011455 FDA 510(k)
FDA Product Code
JDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3350 FDA 510(k)
Regulation Number
888.3350 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Biomet Oncology Salvage System Taper Stacking Adapter is a semi-constrained metal/polymer hip prosthesis designed for cemented fixation. Classified under product code JDI, it serves as an orthopedic device intended to facilitate modularity in hip replacement systems, particularly in salvage procedures where component alignment or stability may require adjustment.

This adapter is supplied as a reusable medical device and is intended for use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K011455) and falls under Class II – Special Controls for orthopedic hip prostheses. No sterility or MRI safety specifications are noted in the available data.

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 Oncology Salvage System (Oss) Taper Stacking Adapter, BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TA... (K011455) - FDA 510(k), Biomet Oncology Salvage System (Oss) Taper Stacking Adapter, Biomet Oncology Salvage System (Oss) Taper Stacking Adapter

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K011455 24 fields · synced Sep 19, 2026