We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Hip Replacement Guiding Tool Cleared by FDA

Hip Replacement Guiding Tool Cleared by FDA

July 31, 2014

Canadian start-up Intellijoint Surgical said Tuesday it received FDA clearance to market the Intellijoint HIP, the company’s sole product. The miniature smart tool guides surgeons during hip replacement surgery.

In particular, the Intellijoint HIP helps to ensure correct leg length and hip offset — the main sources of patient displeasure with hip replacement, the Waterloo, Ontario, company said. The device should reduce liabilities and costs associated with hip implant failure and repeat surgeries, which exceed $1 billion in annual costs to the U.S. healthcare system, the devicemaker added.

The tool — two miniature sensors that are placed in the sterile field and communicate with a portable display — quantifies the measurements, normally left to the surgeon’s personal judgment, that are needed to position the implant. The process adds only a few minutes to a surgery, according to the company.

Intellijoint CEO Armen Bakirtzian told Device Daily Bulletin the Intellijoint HIP will be released immediately in the Eastern U.S. The tool is already approved in Canada, and the company plans to pursue a CE mark as well. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Medical Devices Submissions and Approvals

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 27Jan

    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

  • 09Feb

    Maintaining Your Risk-Based Cleaning and Disinfectant Programs: Best Practices During COVID-19

  • 10Feb

    FDA Under the Biden Administration: What’s to Come and What It Will Mean

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Supreme Court Rejects Merck’s Appeal for $2.5 Billion Patent Verdict Reinstatement

  • FDA clears text

    FDA Clears SCC’s Transfusion-Management Software

  • CE mark

    MiRXES Earns CE Mark for COVID-19/Flu Test

  • KitePharma_Logo

    Kite Pharma’s Tecartus Gains UK Recommendation for Lymphoma

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing