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U2 Total Knee System PSA Tibial Insert

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161360

by United Orthopedic Corporation

Identifiers

510(k) Number
K161360 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 Tibial Insert is a Total Knee Prosthesis designed for primary total knee arthroplasty. It features a polyethylene tibial insert with a posterior-stabilized (PSA) design to enhance joint stability and articulation, providing a durable solution for patients requiring knee replacement surgery.

This device is supplied as a single-use, sterile component intended for use in orthopedic surgical settings. It is manufactured under FDA 510(k) clearance (K161360) and complies with EU Medical Device Directives (MDD, MDR). The PSA Tibial Insert is available in sizes corresponding to the U2 Total Knee System and must be stored in accordance with manufacturer guidelines to maintain sterility and integrity.

Frequently asked questions

What is the U2 Total Knee System PSA Tibial Insert specifically designed for in surgical settings?

The U2 Total Knee System PSA Tibial Insert is designed for primary total knee arthroplasty, meaning it is intended for use in knee replacement surgeries where a patient’s damaged knee joint is replaced with a prosthetic. The posterior-stabilized (PSA) design of the polyethylene insert enhances joint stability and articulation, making it suitable for patients requiring a durable knee replacement solution.

Is the U2 Total Knee System PSA Tibial Insert meant for single-use or can it be reused?

The device is explicitly labeled as a single-use component, meaning it is intended for one surgical procedure only. This classification aligns with standard orthopedic practice to ensure patient safety and sterility, as reusing medical implants carries risks of infection and contamination.

How should the PSA Tibial Insert be stored to maintain its integrity and sterility?

The insert must be stored in accordance with the manufacturer’s guidelines to preserve sterility and structural integrity. Since it is sterile upon packaging, it should remain unopened until use and kept in a clean, dry environment away from direct sunlight or extreme temperatures, as per typical orthopedic implant storage protocols.

What regulatory pathways does the U2 Total Knee System PSA Tibial Insert follow?

The device has undergone FDA 510(k) clearance (K161360) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It also complies with EU Medical Device Directives (MDD) and the Medical Device Regulation (MDR), ensuring it meets both U.S. and European regulatory standards for orthopedic implants.

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) K161360 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 24, 2026