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U2 Bipolar Implant and 22mm Femoral Head

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152439

by United Orthopedic Corporation

Identifiers

510(k) Number
K152439 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 U2 Bipolar Implant and 22mm Femoral Head is a bipolar hip prosthesis designed for total hip arthroplasty. It features a modular femoral component with a 22mm head diameter, intended for use in primary or revision hip replacement procedures to restore joint function and alleviate pain.

This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under the FDA’s product code KWY and has received FDA 510(k) clearance, MDD, and MDR authorizations. The implant is engineered for compatibility with standard surgical techniques and is available in the specified 22mm femoral head size.

Frequently asked questions

What types of hip replacement surgeries is the U2 Bipolar Implant and 22mm Femoral Head intended for, and how does its modular design benefit the procedure?

The U2 Bipolar Implant with a 22mm femoral head is designed for both primary and revision total hip arthroplasty procedures. Its modular femoral component allows surgeons to adapt the implant to the patient’s anatomy during surgery, improving fit and stability. This flexibility is particularly useful in revision cases where bone loss or damage may require customization, helping to restore joint function and reduce pain more effectively.

Is this device single-use, and if so, what does that mean for surgical planning and inventory management?

Yes, the U2 Bipolar Implant is intended for single-use only, meaning it is supplied sterile and should not be reused after a single surgical procedure. This ensures patient safety by minimizing infection risks. For surgical planning, this means you’ll need to account for the implant in your sterile supply chain and ensure proper inventory levels to avoid shortages during procedures. Since it’s sterile upon receipt, no additional sterilization is required before use.

What regulatory pathways has this device undergone, and how does that affect its use in clinical settings?

The U2 Bipolar Implant has undergone FDA 510(k) clearance, as well as MDD (Medical Device Directive) and MDR (Medical Device Regulation) authorizations, confirming its compliance with stringent safety and performance standards in the U.S. and EU markets. This means it can be legally marketed and used in those regions for its intended purpose—total hip arthroplasty—while adhering to established clinical guidelines. The FDA’s classification under product code KWY (Orthopedic, Hip Prosthesis) further supports its use in orthopedic surgeries.

Are there different sizes or models available for this implant, and if not, why is the 22mm femoral head the standard choice?

Currently, the U2 Bipolar Implant is available exclusively with a 22mm femoral head diameter, as specified in the device description. The 22mm size is a common choice for total hip replacements because it balances joint stability, range of motion, and compatibility with standard acetabular components, reducing dislocation risks while maintaining natural hip mechanics. This standardized size simplifies inventory and surgical planning, though surgeons may still adjust positioning or use complementary implants (e.g., stems or liners) to address individual patient needs.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
United Orthopedic Corporation

Sources (2)

  • FDA 510(k) K152439 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026