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U2 Hip Stem, Ti Plasma Spray

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062978

by United Orthopedic Corp.

Identifiers

510(k) Number
K062978 FDA 510(k)
FDA Product Code
LWJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3360 FDA 510(k)
Regulation Number
888.3360 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The U2 Hip Stem is a cementless femoral revision component for hip arthroplasty, featuring a cylindrical titanium plasma spray coating designed to promote biological fixation. Constructed from titanium alloy (ASTM F620), it includes a tapered geometry with a tear-drop distal tip to facilitate insertion and reduce cortical impingement. The device is intended for use in revision surgeries where soft tissue contracture or prior surgical interventions may complicate joint reduction.

This device is supplied as a reusable surgical implant, requiring sterile processing before use. It is available in a Matrix size distribution and includes a polished distal design to mitigate proximal stress shielding. The U2 Hip Stem holds an FDA 510(k) clearance under product code LWJ, with no third-party review indicated. Storage and handling must comply with orthopedic implant protocols to maintain sterility and structural integrity.

Frequently asked questions

Is the U2 Hip Stem designed for primary hip replacements, or is it specifically for revision surgeries?

The U2 Hip Stem is exclusively intended for revision surgeries, not primary hip replacements. Its design—including the cylindrical titanium plasma spray coating and tapered geometry—addresses challenges common in revisions, such as soft tissue contracture or prior surgical interventions that may complicate joint reduction. This distinguishes it from primary stems, which typically prioritize initial stability and bone ingrowth in virgin tissue.

How is the U2 Hip Stem sterilized and prepared for use in the operating room?

The U2 Hip Stem is a reusable surgical implant that requires sterile processing before use, per standard orthopedic implant protocols. It is not pre-sterilized as a single-use device; instead, it must undergo cleaning, disinfection, and sterilization (e.g., autoclave or ethylene oxide) by the surgical facility’s sterile processing department to ensure sterility and structural integrity prior to implantation.

What materials is the U2 Hip Stem made from, and how does the titanium plasma spray coating contribute to its function?

The stem is constructed from titanium alloy (ASTM F620) for its strength and biocompatibility. The titanium plasma spray coating is applied to promote biological fixation—it encourages bone ingrowth and osseointegration, which is critical in revision cases where bone quality or prior surgeries may compromise stability. The coating also helps distribute loads more evenly to reduce stress shielding proximally.

Are there multiple sizes available for the U2 Hip Stem, and how does the tear-drop distal tip benefit the procedure?

Yes, the U2 Hip Stem is available in a Matrix size distribution, meaning it comes in a range of sizes to accommodate varying femoral anatomies in revision patients. The tear-drop distal tip is designed to facilitate easier insertion by reducing cortical impingement during seating, which can be particularly helpful in revision surgeries where bone stock or soft tissue may be compromised or scarred.

What regulatory pathway was followed for FDA clearance of the U2 Hip Stem, and what does the product code LWJ indicate?

The U2 Hip Stem received FDA 510(k) clearance through a Traditional review pathway under product code LWJ, which categorizes it as an orthopedic device for hip arthroplasty. The clearance was determined under the Substantially Equivalent (SESE) decision code, meaning the device was found to have the same intended use, technological characteristics, and performance as a legally marketed predicate device. The Orthopedic (OR) advisory committee was the designated review panel, though no third-party review was involved.

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: U2 Revision Stem | United Orthopedic Corporation | Hip and Knee Implants, U2 Hip Stem | United Orthopedic Corporation | Hip and Knee Implants, U2 HIP STEM, TI PLASMA SPRAY (K062978) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
United Orthopedic Corp.

Sources (1)

  • FDA 510(k) K062978 24 fields · synced Sep 19, 2026