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Hoffmann LRF System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K163656

by Stryker GmbH

Identifiers

510(k) Number
K163656 FDA 510(k)
FDA Product Code
KTT 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 Hoffmann LRF System is a Laser Range Finder (Device Type: KTT) designed for precise measurement and alignment in orthopedic surgical procedures. It employs laser technology to accurately determine distances and angles, aiding in the placement of implants and instruments with high precision.

This system is supplied as a reusable medical device, intended for use in sterile operating environments. It is approved under FDA 510K clearance (K163656) and MDR, with no specific MRI safety restrictions noted. The device is intended for professional use by trained personnel in orthopedic surgery settings and requires proper calibration and maintenance as per manufacturer guidelines.

Frequently asked questions

What types of orthopedic procedures is the Hoffmann LRF System designed to assist with, and why is laser precision important in these settings?

The Hoffmann LRF System is designed to aid in precise measurement and alignment during orthopedic surgical procedures, particularly where implant placement or instrument positioning requires high accuracy. Laser precision is critical in these settings because even minor deviations can affect joint stability, implant fit, or recovery outcomes. For example, in knee or hip replacements, accurate alignment ensures proper biomechanics and reduces complications like implant loosening or wear over time.

Is the Hoffmann LRF System intended for single-use or reusable applications, and what maintenance does it require?

The Hoffmann LRF System is explicitly supplied as a reusable medical device, meaning it is engineered for repeated use in sterile operating environments. Since it is reusable, it requires proper calibration and maintenance as outlined by the manufacturer to ensure consistent performance and accuracy. Regular servicing helps preserve its precision, which is essential for reliable surgical measurements.

Are there any special storage or handling instructions for the Hoffmann LRF System, particularly given its use in sterile environments?

While the device is reusable and designed for sterile operating environments, the provided data does not specify detailed storage instructions beyond its intended use in sterile surgical settings. However, since it is a reusable laser-based system, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage to its optical components. Always follow manufacturer guidelines for cleaning and sterilization protocols to maintain functionality.

Does the Hoffmann LRF System have any restrictions regarding use in MRI environments, and if so, why?

The Hoffmann LRF System has no specific MRI safety restrictions noted in the provided data, meaning it is not explicitly labeled as unsafe for use in MRI environments. However, this does not imply compatibility—laser-based devices can still pose risks in MRI settings due to potential interference with magnetic fields or electromagnetic interference. Clinicians should consult the manufacturer’s instructions and local MRI safety protocols before use in such environments.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker GmbH

Sources (2)

  • FDA 510(k) K163656 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026