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U2 Total Knee System-PF+

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221705

by United Orthopedic Corporation

Identifiers

510(k) Number
K221705 FDA 510(k)
FDA Product Code
MBH FDA 510(k)

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+ is a Press-Fit Total Knee Replacement (TKR) System designed for primary and revision arthroplasty. It features a three-dimensional coating optimized for pore size and porosity, a conforming femoral component available in 13 sizes with 2 mm anterior-posterior and medial-lateral sizing increments, and a unique box design for enhanced fixation.

This system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use implant. The device adheres to FDA 510(k) clearance under the Orthopedic Advisory Committee (OR) with a Traditional review pathway. Sizes are standardized for compatibility with modular instrumentation, and regulatory compliance is maintained through the assigned product code MBH and k-number K221705.

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: U2 Knee | USA United Orthopedic Corporation | Hip and Knee Implants, U2 PF+ Knee | United Orthopedic Corporation | Hip and Knee Implants, Knee | United Orthopedic Corporation | Hip and Knee Implants, U2 Knee | USA United Orthopedic Corporation | Hip and Knee Implants

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) K221705 24 fields · synced Oct 6, 2026