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U-Motion II Acetabular System – Additional Sizes

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K170089

by United Orthopedic Corporation

Identifiers

510(k) Number
K170089 FDA 510(k)
FDA Product Code
LZO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3353 FDA 510(k)
Regulation Number
888.3353 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The U-Motion II Acetabular System – Additional Sizes is a modular acetabular component designed for total hip arthroplasty. It features enhanced design elements to improve stability, fit, and biomechanical performance in primary and revision hip replacements, with expanded sizing options to accommodate diverse anatomical variations.

This system is supplied sterile and intended for single-use in orthopedic surgical settings. It adheres to FDA 510(k) clearance under the Traditional pathway, with additional compliance under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The modular design includes extended size variants to ensure compatibility with various patient anatomies, and it is regulated as a Class III device under applicable standards.

Frequently asked questions

What types of hip surgeries is the U-Motion II Acetabular System designed for, and how does its modularity help in those procedures?

The U-Motion II Acetabular System is designed for both primary and revision total hip arthroplasty procedures. Its modular design, combined with expanded size variants, enhances stability and fit, accommodating diverse anatomical variations. This flexibility is particularly useful in revision surgeries where bone loss or irregularities may require custom sizing to ensure proper alignment and function.

Is the U-Motion II Acetabular System intended for reuse, or is it meant to be used only once per patient?

The U-Motion II Acetabular System is explicitly intended for single-use in orthopedic surgical settings. This ensures patient safety and sterility, as it is supplied sterile and designed to be discarded after one surgical procedure.

What regulatory pathways has the U-Motion II Acetabular System followed, and what does that mean for its use in clinical settings?

The U-Motion II Acetabular System has undergone FDA 510(k) clearance through the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), which are European regulatory frameworks. This ensures it meets stringent safety, performance, and quality standards for use in clinical settings.

How are the additional sizes in this system beneficial compared to standard acetabular components?

The additional sizes in the U-Motion II Acetabular System provide expanded anatomical coverage, allowing for better compatibility with patients who have unique or complex hip structures. This is particularly advantageous in revision surgeries or for patients with irregular bone morphology, as it reduces the need for custom implants and improves the likelihood of a stable, well-fitting prosthesis.

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) K170089 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 29, 2026