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Xpert Knee

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250155

by Newclip Technics

Identifiers

510(k) Number
K250155 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Xpert Knee is an orthopedic fixation device classified as an orthopedic fixation device under the FDA’s orthopedic advisory committee. It is designed for the osteosynthesis of fractures, nonunions, and malunions in the adult knee, with a focus on tibial plateau trauma. The system includes anatomical plates tailored to address complex fracture patterns, including posterolateral, posteromedial, and posterior configurations. Its construction enables precise stabilization to restore joint alignment and promote healing in challenging fracture sites.

Xpert Knee plates are supplied sterile and intended for single-use. They are engineered for use in orthopedic surgical settings, where they are affixed to the tibial plateau to secure bone fragments during fracture repair. The device is regulated under the FDA’s 510(k) pathway (K250155) and falls under the product code HRS. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and integrity prior to 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. Sources consulted: Xpert Knee - Newclip Technics, PDF TIBIAL PLATEAU TRAUMA PLATES - newcliptechnics.com, Xpert Knee - Newclip Technics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Newclip Technics

Sources (1)

  • FDA 510(k) K250155 24 fields · synced Oct 1, 2026