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Kyocera Bipolar Hip System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200709

by Kyocera Medical Technologies, Inc.

Identifiers

510(k) Number
K200709 FDA 510(k)
FDA Product Code
KWY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3390 FDA 510(k)
Regulation Number
888.3390 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Kyocera Bipolar Hip System is a bipolar femoral head component designed for use in total hip arthroplasty. It replaces the natural femoral head, articulating with a femoral head implant and hip stem to restore joint function. This modular component is intended for integration with compatible femoral stems and acetabular systems, providing a bearing surface for hip mobility. The device is classified under orthopedic implants and is engineered to enhance durability and range of motion in hip replacement procedures.

The Kyocera Bipolar Hip System is supplied as a sterile, single-use orthopedic implant and is intended for use in surgical settings by qualified orthopedic surgeons. It is regulated under FDA 510(k) clearance (K200709) and falls under the product code KWY for orthopedic devices. The system is designed for compatibility with specific femoral stems and acetabular components, ensuring proper articulation and joint stability. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to implantation.

Frequently asked questions

What is the Kyocera Bipolar Hip System used for in a total hip replacement procedure?

The Kyocera Bipolar Hip System is designed as a bipolar femoral head component for total hip arthroplasty, replacing the natural femoral head to restore joint function. It articulates with a femoral stem and head implant, providing a modular bearing surface to improve durability and range of motion. It is intended for use with compatible femoral stems and acetabular systems to ensure proper joint stability.

Is the Kyocera Bipolar Hip System meant for single-use or can it be reused?

The Kyocera Bipolar Hip System is explicitly labeled as sterile and single-use, meaning it is intended for one surgical procedure only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

How should the Kyocera Bipolar Hip System be stored before use?

The device must be stored following sterile medical device protocols to preserve its integrity. Since it is single-use, it should remain in its original packaging until immediately before surgery, in a clean, controlled environment to prevent contamination or damage.

What regulatory pathway does the Kyocera Bipolar Hip System follow, and what does that mean for its use?

The Kyocera Bipolar Hip System is cleared under the FDA 510(k) pathway (K200709) with a Special clearance type and classified under product code KWY (orthopedic devices). This means it has been determined to be substantially equivalent to a legally marketed predicate device, allowing its use in surgical settings by qualified orthopedic surgeons as intended for total hip arthroplasty.

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: BiPolar Hip System - KYOCERA Medical Technologies, Downloads, K200709 - Kyocera Bipolar Hip System - Orthopedic, Kyocera Document Solutions - Making information faster, Hip Joint - KYOCERA Medical Technologies, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kyocera Medical Technologies, Inc.

Sources (1)

  • FDA 510(k) K200709 24 fields · synced Sep 20, 2026