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United U2 XPE Total Knee System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103733

by United Orthopedic Corporation

Identifiers

510(k) Number
K103733 FDA 510(k)
FDA Product Code
JWH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The United U2 XPE Total Knee System is a modular total knee arthroplasty device designed to replace damaged knee joints, restoring mobility and function through a range of interchangeable components. It falls under the orthopedic device category, featuring polyethylene and metallic implants tailored for primary and revision procedures.

This system is intended for use in orthopedic surgical settings by trained professionals, adhering to standard aseptic techniques. Supplied as a sterile, single-use device, it is regulated under FDA 510(k) clearance (K103733) and classified under product code JWH. Storage and handling must comply with manufacturer guidelines to maintain sterility and performance.

Frequently asked questions

What types of knee procedures is the United U2 XPE Total Knee System designed for, and how does its modularity benefit surgeons?

The United U2 XPE Total Knee System is specifically designed for both primary and revision total knee arthroplasty procedures. Its modularity allows surgeons to select and interchange components—such as polyethylene inserts and metallic implants—tailored to the patient’s anatomy and clinical needs. This flexibility ensures a more precise fit, potentially improving stability, longevity, and patient outcomes while accommodating complex cases.

Is the United U2 XPE Total Knee System intended for reuse, or is it single-use only? How should it be stored to maintain sterility?

The United U2 XPE Total Knee System is sterile and single-use only, as explicitly stated in the manufacturer’s guidelines. To preserve sterility and performance, it must be stored according to the manufacturer’s instructions, typically in a sealed, sterile packaging until immediately before use. Avoid exposure to moisture, extreme temperatures, or contamination.

What regulatory pathway was followed for FDA clearance of this device, and what does the product code (JWH) indicate about its classification?

The United U2 XPE Total Knee System received FDA clearance via a 510(k) submission (K103733), classified as substantially equivalent to a predicate device. The product code JWH categorizes it under orthopedic knee prostheses, confirming its use as a total knee arthroplasty system rather than a partial or other orthopedic implant.

Are there different sizes or models available for the United U2 XPE Total Knee System, and how might a surgeon determine the appropriate fit for a patient?

While the exact sizing options aren’t detailed in the provided data, the system’s modular design implies a range of component sizes to accommodate varying patient anatomies. Surgeons typically determine the appropriate fit using preoperative imaging (e.g., X-rays or CT scans) and intraoperative assessment, selecting components from the system’s available inventory to ensure proper alignment and function.

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 Knee | USA United Orthopedic Corporation | Hip and Knee Implants, PDF Comprehensive Total Knee System - unitedorthopedic.com, PDF Une e U2 Knee - unitedorthopedic.com, U2 Knee | USA United Orthopedic Corporation | Hip and Knee Implants

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
United Orthopedic Corporation

Sources (1)

  • FDA 510(k) K103733 24 fields · synced Oct 6, 2026