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Klassic HD Hip System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171962

by Total Joint Othopedics, Inc.

Identifiers

510(k) Number
K171962 FDA 510(k)
FDA Product Code
LPH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3358 FDA 510(k)
Regulation Number
888.3358 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Klassic HD Hip System is a total hip arthroplasty device designed to restore hip joint function and biomechanics. It includes femoral stems, acetabular cups, acetabular inserts, and ceramic femoral heads, engineered for long-term stability and fixation. The system incorporates ultra-porous Ti-Coat fixation with multi-wedge morphology to enhance initial implant stability and promote biological integration. This design supports a range of surgical approaches while maintaining structural integrity and patient comfort.

The Klassic HD Hip System is supplied as a modular orthopedic implant kit, intended for use in orthopedic surgical settings by trained professionals. Components are reusable and sterilized via manufacturer-approved methods prior to packaging. The system is cleared under FDA 510(k) Special Review (K171962) for substantial equivalence to predicate devices, with specific additions of smaller acetabular cup sizes, inserts, and femoral head variants. Storage and handling must adhere to sterile orthopedic implant protocols to ensure device integrity and patient safety.

Frequently asked questions

What is the Klassic HD® Hip System used for?

The Klassic HD® Hip System is designed for total hip arthroplasty to restore function and biomechanics in patients with hip joint damage or degenerative conditions. Its modular components—femoral stems, acetabular cups, inserts, and ceramic heads—allow surgeons to customize the implant to fit individual anatomy and surgical needs. The ultra-porous Ti-Coat fixation enhances initial stability and promotes long-term biological integration, supporting recovery and mobility.

How is the Klassic HD® Hip System supplied, and is it single-use?

The system is supplied as a modular orthopedic implant kit, intended for reuse by trained professionals in sterile surgical settings. Components are sterilized via manufacturer-approved methods prior to packaging, ensuring compliance with orthopedic implant protocols. Unlike disposable devices, this system is engineered for repeated use under strict sterile handling and maintenance guidelines.

What distinguishes the fixation technology in this hip system?

The Klassic HD® Hip System features ultra-porous Ti-Coat fixation with a multi-wedge morphology on femoral stems. This design enhances initial implant stability by maximizing surface area for bone contact and promotes biological integration over time. The porous coating encourages bone ingrowth, reducing micromotion and improving long-term fixation compared to traditional smooth or roughened surfaces.

Are there different sizes or models available for the acetabular cups and femoral heads?

Yes, the system includes expanded acetabular cup sizes and a variety of femoral head variants to accommodate diverse patient anatomies and surgical preferences. This modularity allows clinicians to select components that optimize joint alignment, range of motion, and biomechanical balance. The FDA clearance for this device specifically highlights these additions as key improvements over predicate models.

What storage and handling requirements apply to the Klassic HD® Hip System?

The Klassic HD® Hip System must be stored and handled according to sterile orthopedic implant protocols to preserve device integrity and ensure patient safety. Components should remain in sealed, manufacturer-approved packaging until use, protected from contamination or physical damage. Post-use, components must undergo manufacturer-approved sterilization before reuse to maintain sterility and functionality.

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: Klassic HD® HIP System - TJO - Total Joint Orthopedics, PDF ART-LB90040L Klassic HD Hip Implant IFU.indd, PDF Total Joint Orthopedics, Inc. - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Total Joint Othopedics, Inc.

Sources (1)

  • FDA 510(k) K171962 24 fields · synced Oct 1, 2026