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Intellitorq

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K180092

by Gauthier Biomedical, Inc.

Identifiers

510(k) Number
K180092 FDA 510(k)
FDA Product Code
HXC FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 888.4540 FDA 510(k)
Regulation Number
888.4540 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Intellitorq is a torque-limiting surgical instrument designed for orthopedic applications, specifically for controlled torque delivery during orthopedic procedures. It is classified as a Class I orthopedic device under the FDA’s 510(k) pathway, with a substantially equivalent determination for its intended use in orthopedic surgery.

Intellitorq is supplied as a reusable device and is intended for use in controlled environments such as operating rooms. It features a torque tolerance of ±1% and is authorized under FDA 510(k) clearance (K180092), MDD, and MDR. The device is manufactured by Gauthier Biomedical, Inc., and its specifications are governed by regulatory compliance standards for orthopedic instrumentation.

Frequently asked questions

What types of orthopedic procedures is the Intellitorq designed to assist with, and how does its torque control feature benefit these procedures?

The Intellitorq is specifically engineered for controlled torque delivery during orthopedic surgeries where precise rotational force is critical. Its ±1% torque tolerance ensures consistent and accurate application, reducing the risk of over-tightening or under-tightening screws, implants, or fixation devices. This precision is particularly valuable in procedures like internal fixation, joint replacements, or fracture stabilization where stability and alignment are paramount.

Is the Intellitorq intended for single-use or reusable applications, and what maintenance considerations should be kept in mind?

The Intellitorq is designed as a reusable device, meaning it is engineered for repeated use in controlled environments like operating rooms. Since it is reusable, proper cleaning, sterilization, and maintenance protocols must be followed to ensure reliability and safety between procedures. The manufacturer’s guidelines should be consulted for specific cleaning and sterilization instructions to preserve its torque accuracy and functional integrity.

What regulatory pathways has the Intellitorq undergone, and how does this affect its use in clinical settings?

The Intellitorq has undergone FDA 510(k) clearance (K180092), as well as compliance under the MDD (Medical Device Directive) and MDR (Medical Device Regulation). These authorizations confirm that the device meets regulatory standards for safety and performance in orthopedic applications. Clinicians can rely on its compliance with these frameworks, ensuring it adheres to established guidelines for torque-limiting instruments in surgical settings.

How is the Intellitorq supplied, and are there specific storage requirements to maintain its functionality?

The Intellitorq is supplied as a reusable device, meaning it is intended for use in clinical environments like operating rooms after proper cleaning and sterilization. While the data does not specify exact storage conditions, reusable surgical instruments generally require protection from contamination, moisture, and physical damage. Storage should follow standard orthopedic instrumentation protocols to preserve its torque precision and structural integrity until the next 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: Gauthier Biomedical, Inc. - IntelliTorq®, Gauthier Biomedical - High-Quality Medical Instruments, Gauthier Biomedical Patent List, K180092 FDA 510 (k) - Intellitorq | Gauthier Biomedical, Inc.

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
Gauthier Biomedical, Inc.

Sources (2)

  • FDA 510(k) K180092 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026