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I-Hip Total Hip System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132572

by Iconacy Orthopedic Implants, LLC

Identifiers

510(k) Number
K132572 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 I-Hip Total Hip System is a total hip replacement system consisting of a collarless, tapered, forged titanium alloy femoral stem, a modular femoral head, a hemispherical titanium alloy acetabular cup, and a highly cross-linked UHMWPE liner. It is indicated for patients with a severely painful or disabled hip joint resulting from conditions such as osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, or acute traumatic fracture of the femoral head or neck.

This system features porous coated components designed for cementless, press-fit fixation. The device is identified by K-number K132572 and has received FDA 510(k) clearance. It is intended for use in patients who have experienced a failed previous hip procedure.

Frequently asked questions

What conditions is the I-Hip Total Hip System indicated for?

This system is indicated for patients suffering from severely painful or disabled hip joints. Specific conditions include osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, or acute traumatic fracture of the femoral head or neck. It is also intended for patients who have experienced a failed previous hip procedure.

How is the I-Hip Total Hip System fixed into the bone?

The system is designed for cementless, press-fit fixation. It utilizes porous coated components on the femoral stem and acetabular cup to facilitate this type of attachment, avoiding the need for bone cement.

What materials are used in the construction of this hip system?

The femoral stem and the hemispherical acetabular cup are manufactured from a forged titanium alloy. The system also includes a modular femoral head and a highly cross-linked UHMWPE liner to complete the total hip replacement assembly.

What is the regulatory status of the I-Hip Total Hip System?

The I-Hip Total Hip System has received FDA 510(k) clearance under the K-number K132572. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

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: I-HIP TOTAL HIP SYSTEM (K132572) — FDA 510 (k) | Innolitics, ICONACY(TM) I-Hip (TM) (K151307) — FDA 510(k) | Innolitics, OrthoAxis - Product

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Iconacy Orthopedic Implants, LLC

Sources (1)

  • FDA 510(k) K132572 24 fields · synced Sep 21, 2026