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U2 Total Knee System – PSA Type, Offset Stem Adapter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131116

by United Orthopedic Corporation

Identifiers

510(k) Number
K131116 FDA 510(k)
FDA Product Code
JWH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3560 FDA 510(k)
Regulation Number
888.3560 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The U2 Total Knee System – PSA Type, Offset Stem Adapter is a posterior-stabilized knee arthroplasty designed for primary and revision total knee replacements. It features an offset stem adapter to address complex bone defects, enhancing stability and facilitating customised implant positioning for improved joint function.

This device is intended for use in orthopaedic surgical settings and is supplied as a sterile, single-use implant. The system is authorised under FDA 510(k) clearance (K131116) and adheres to traditional review standards. The offset stem adapter is part of a modular design, enabling surgeons to tailor solutions for varying degrees of bone loss and soft tissue imbalance.

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 PSA Knee | United Orthopedic Corporation | Hip and Knee Implants, U2 Knee | United Orthopedic Corporation | Hip and Knee Implants, U2 PSA™ Knee | Products | Knee | United Orthopedic UK

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) K131116 24 fields · synced Oct 6, 2026