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U2 Total Knee System – PF+ Patella; USTAR II System – PF+ Patella

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K243656

by United Orthopedic Corporation

Identifiers

510(k) Number
K243656 FDA 510(k)
FDA Product Code
MBH FDA 510(k)
Models / Variants
U2 Total Knee System – PF+ Patella FDA 510(k)EUDAMED
USTAR II System– PF+ Patella FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3565 FDA 510(k)
Regulation Number
888.3565 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The U2 Total Knee System – PF+ Patella and USTAR II System – PF+ Patella are total knee arthroplasty implants designed for primary total knee replacement procedures. These systems include modular components for the femoral, tibial, and patellar surfaces, enabling customised alignment and articulation to restore knee function and mobility in patients with degenerative joint disease or trauma-related knee damage.

The devices are supplied sterile and intended for single-use in orthopaedic surgical settings. They comply with FDA 510(k) clearance under the Traditional pathway, European Medical Device Directive (MDD), and Medical Device Regulation (MDR). Components are available in standard sizes and configurations, with detailed surgical techniques provided separately. No MRI safety information is specified in the data.

Frequently asked questions

What types of knee conditions is this system designed to address in patients?

The U2 Total Knee System – PF+ Patella and USTAR II System – PF+ Patella are specifically designed for primary total knee replacement procedures in patients suffering from degenerative joint disease or trauma-related knee damage. These systems are engineered to restore knee function and mobility through modular components for the femoral, tibial, and patellar surfaces, allowing for customized alignment and articulation.

Are these implants reusable or intended for single-use, and how are they supplied?

The U2 and USTAR II PF+ Patella systems are sterile and intended for single-use only in orthopedic surgical settings. They are supplied pre-sterilized to ensure safety and efficacy for one surgical procedure, eliminating the need for reprocessing or reuse.

What types of modular components are included in these systems, and how do they contribute to customization?

Both systems include modular components for the femoral, tibial, and patellar surfaces, allowing surgeons to select sizes and configurations tailored to each patient’s anatomy. This modularity enables precise alignment and articulation, which helps restore knee function and mobility after primary total knee replacement.

How are these devices regulated, and what pathways have they followed for approval?

The U2 and USTAR II PF+ Patella systems have undergone FDA 510(k) clearance under the Traditional pathway, as well as compliance with the European Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means they meet regulatory standards for safety and performance in the U.S. and EU markets, respectively.

Are there any specific storage requirements mentioned for these implants?

While the provided data does not specify detailed storage conditions, the implants are supplied sterile and intended for single-use in surgical settings. Standard sterile storage practices—such as protecting from contamination, extreme temperatures, and moisture—should be followed to maintain integrity until use.

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

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
United Orthopedic Corporation

Sources (2)

  • FDA 510(k) K243656 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026