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UTF Stem Reduced

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123550

by United Orthopedic Corporation

Identifiers

510(k) Number
K123550 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 UTF Stem Reduced is a primary hip implant classified as a Femoral Stem for Total Hip Arthroplasty (Product Code LPH). It features a dual taper wedge design intended to engage cortical bone, enhancing fixation and stability in the proximal femur.

This device is supplied sterile and intended for single-use in orthopedic surgery. It is manufactured by United Orthopedic Corporation and holds FDA 510(k) clearance (K123550) under the Traditional review pathway. The device is not MRI-safe and must be stored as directed by the manufacturer.

Frequently asked questions

What is the UTF STEM, REDUCED designed to do in a patient’s anatomy?

The UTF STEM, REDUCED is a primary hip implant specifically designed as a femoral stem for total hip arthroplasty (THA). Its dual taper wedge design is engineered to engage the cortical bone in the proximal femur, which helps improve fixation and stability during and after surgery. This makes it suitable for patients requiring a replacement of the hip joint’s femoral component.

Is this device meant to be reused in multiple patients, or is it single-use only?

The UTF STEM, REDUCED is intended for single-use only in orthopedic surgery. This is explicitly stated in the device’s specifications, ensuring patient safety and sterility standards are maintained. Reuse is not recommended or supported by the manufacturer.

How should I store the UTF STEM, REDUCED before use, and does it come sterile?

The device is supplied sterile and must be stored as directed by the manufacturer to preserve its integrity. While the exact storage instructions aren’t detailed here, the sterility and single-use nature emphasize the importance of following the manufacturer’s guidelines—typically involving sealed packaging, protection from contamination, and adherence to temperature or humidity constraints.

Can this device be used in an MRI environment, or are there any special considerations?

The UTF STEM, REDUCED is not MRI-safe, meaning it should not be used in MRI environments. This is a critical consideration for postoperative planning, as MRI scans may be required for follow-up imaging. Always confirm with the manufacturer’s instructions and consult radiology teams before scheduling MRI procedures for patients with this implant.

What regulatory pathway was followed for FDA clearance of this device, and who should I contact for further inquiries?

The UTF STEM, REDUCED received FDA 510(k) clearance (K123550) under the Traditional review pathway, with a decision described as Substantially Equivalent (SESE) by the Orthopedic (OR) Advisory Committee. For further inquiries—such as technical details, clinical support, or regulatory documentation—the manufacturer, United Orthopedic Corporation, can be reached through their contact at FANG-YUAN HO at their address in Hsinchu, Taiwan.

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: UTF Reduced Stem | United Orthopedic Corporation | Hip and Knee Implants, Hip | United Orthopedic Corporation | Hip and Knee Implants, Products | USA United Orthopedic Corporation | Hip and Knee Implants, PDF United rtpedic UTF Reduced Stem - grupoalemana.com

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) K123550 24 fields · synced Oct 6, 2026