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Arthroscope / Medifix Inc.

by Medifix, Inc.

510(k) K992474

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992474 Date23 Sep 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an arthroscope, a Class II orthopedic instrument used for visualizing, diagnosing, and treating joint conditions. It is designed to be inserted into a joint through a small incision, allowing surgeons to examine internal structures such as cartilage, ligaments, and menisci via an optical system and attached camera. The device aids in minimally invasive procedures, reducing tissue trauma and accelerating patient recovery compared to traditional open surgery methods.

The Arthroscope / Medifix Inc. is supplied as a reusable medical device and is intended for use in sterile operating room environments. It is classified under product code HRX and has been cleared through the FDA’s Traditional 510(k) pathway, with a clearance date of September 23, 1999. No specific MRI safety or sterility standards beyond standard surgical practices are noted in the regulatory filing. The device is intended for professional use by trained orthopedic surgeons and is not intended for home or patient self-administration.

Other devices from Medifix, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Medifix Arthroscope used for?

    The Medifix Arthroscope is designed for visualizing, diagnosing, and treating joint conditions. It allows surgeons to examine internal structures like cartilage, ligaments, and menisci through a small incision, enabling minimally invasive procedures. This reduces tissue trauma and helps patients recover more quickly compared to traditional open surgery.

  • Is the Medifix Arthroscope reusable or single-use?

    The Medifix Arthroscope is supplied as a reusable medical device. It is intended for use in sterile operating room environments, adhering to standard surgical practices for reprocessing and sterilization.

  • What regulatory pathway was followed for this device?

    The Medifix Arthroscope was cleared through the FDA’s Traditional 510(k) pathway, specifically under the Orthopedic advisory committee. It was determined to be substantially equivalent to a predicate device and received clearance on September 23, 1999.

  • Are there any special storage or handling requirements for this device?

    While the regulatory filing does not specify unique MRI safety or sterility standards beyond standard surgical practices, the device must be handled in accordance with general orthopedic instrument care. It should be stored in a clean, dry environment and reprocessed following manufacturer guidelines to maintain sterility and functionality.

  • Who is authorized to use the Medifix Arthroscope?

    The device is intended exclusively for professional use by trained orthopedic surgeons in clinical settings. It is not designed for home use or self-administration by patients.