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USTAR II System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190100

by United Orthopedic Corporation

Identifiers

510(k) Number
K190100 FDA 510(k)
FDA Product Code
KRO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3510 FDA 510(k)
Regulation Number
888.3510 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The USTAR II System is a Constrained Femorotibial Knee Prosthesis (Metal/Polymer, Cemented), designed for total knee arthroplasty. It provides constrained articulation to enhance stability in complex cases, including ligament-deficient knees, while maintaining durability through metal-polymer bearing surfaces.

This system is intended for single-use in sterile surgical settings and is supplied as a sterile, implantable device. It is classified under FDA Device Class II (KRO) and has received FDA 510(k) clearance, MDD, and MDR authorisations. Multiple sizes and configurations are available to accommodate varying patient anatomies, with regulatory compliance ensured through the specified registration numbers.

Frequently asked questions

What types of knee conditions is the USTAR II System specifically designed to address in surgical settings?

The USTAR II System is a constrained femorotibial knee prosthesis designed for total knee arthroplasty, particularly in complex cases such as ligament-deficient knees. Its constrained articulation enhances stability, making it suitable for patients with significant ligament instability or other challenging anatomical conditions.

Is the USTAR II System intended for reuse in surgical procedures, or is it meant for single-use only?

The USTAR II System is explicitly designed for single-use in sterile surgical settings. This ensures patient safety and compliance with sterile surgical protocols, as reuse is not recommended or supported by the manufacturer.

How many sizes and configurations are available for the USTAR II System, and how does this accommodate different patient anatomies?

The USTAR II System offers multiple sizes and configurations to match varying patient anatomies. While the exact number of sizes isn’t specified, the system includes a range of components (as evidenced by the extensive list of FEI numbers and registration numbers), ensuring flexibility for surgeons to select the appropriate fit for individual patients during total knee arthroplasty.

What regulatory pathways has the USTAR II System undergone, and what does this mean for its use in clinical practice?

The USTAR II System has received FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. This means it has been evaluated for safety and effectiveness according to applicable regulatory standards, allowing its use in clinical practice within jurisdictions where these approvals are recognized. The system is classified under FDA Device Class II (KRO), indicating a moderate level of regulatory oversight.

How should the USTAR II System be stored before use, and is it provided in a sterile package?

The USTAR II System is supplied as a sterile, implantable device, meaning it is pre-packaged and ready for use in sterile surgical settings. Proper storage should follow the manufacturer’s guidelines to maintain sterility, though specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data. Always refer to the packaging instructions for detailed storage requirements.

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) K190100 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026