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Footmotion Plating System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161448

by Newclip Technics

Identifiers

510(k) Number
K161448 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 Footmotion Plating System is an orthopedic device designed for the treatment of fractures, osteotomies, and arthrodesis of small bones and bone fragments. It consists of compressive straight plates with a ramp oblong hole feature that allows for compression to be added to the construct.

The system is supplied as a kit containing 6 implants ranging from 2 holes to 7 holes. It is intended for use by trained and qualified staff who have read the instructions before use. The device received FDA 510(k) clearance under K161448 with product code HRS and is classified as a Class IIb medical device under CE marking (CE1639 SGS BE).

Frequently asked questions

What is the Footmotion Plating System used for?

The Footmotion Plating System is designed for the treatment of fractures, osteotomies, and arthrodesis of small bones and bone fragments. It provides stabilization through compressive straight plates that allow compression to be added to the construct via ramp oblong holes, supporting healing in small bone procedures.

How is the Footmotion Plating System supplied and what does the kit include?

The system is supplied as a kit containing 6 implants, ranging from 2 holes to 7 holes. This allows surgeons to select the appropriate plate length based on the size and location of the bone fragment or fracture being treated. The kit is intended for use by trained and qualified staff who have reviewed the instructions prior to use.

Is the Footmotion Plating System sterile and intended for single use?

While the device data does not explicitly state sterility or single-use status, the system is supplied as a kit intended for implantation and is indicated for use by trained staff who have read the instructions. Implantable orthopedic plates like this are typically provided sterile and designed for single use to prevent infection and ensure integrity, but users must consult the labeling for specific handling and reuse guidelines.

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: Footmotion Plating System - Newclip Technics, PDF FOOTMOTION PLATING SYSTEM - newcliptechnics.com, Foot & Ankle. - 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) K161448 24 fields · synced Sep 26, 2026