Design World

  • Home
  • Technologies
    • 3D CAD
    • Electronics • electrical
    • Fastening & Joining
    • Factory automation
    • Linear Motion
    • Motion Control
    • Test & Measurement
    • Sensors
    • Fluid power
  • Learn
    • Ebooks / Tech Tips
    • Engineering Week
    • Future of Design Engineering
    • MC² Motion Control Classrooms
    • Podcasts
    • Videos
    • Webinars
  • LEAP AWARDS
  • Leadership
    • 2022 Voting
    • 2021 Winners
  • Design Guide Library
  • Resources
    • 3D Cad Models
      • PARTsolutions
      • TraceParts
    • Digital Issues
      • Design World
      • EE World
    • Women in Engineering
  • Supplier Listings

FDA Grants 510(k) Clearance For Injectable HA-Based Bone Repair

By Anika Therapeutics, Inc. | December 29, 2017

Share

Anika Therapeutics, Inc., a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (HA) technology, announced that its HA-based bone void filler received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.

The bone void filler, which is composed of a synthetic, biocompatible bone graft substitute material, is injected into a void, hardens at body temperature, and is then resorbed and replaced by the growth of new bone during the healing process.

“Anika’s 510(k) clearance allows for the marketing of one of only a handful of bone graft substitutes that can be administered in a minimally invasive manner,” Dr. John Tierney, D.O., an orthopedic surgeon affiliated with New England Baptist Hospital who has worked with Anika ‘s bone repair treatment, said. “It offers physicians an additional option for treating bone defects or injuries, without the need for expensive and high risk surgeries, while also reducing the operating room time spent on each case.”

Over one million musculoskeletal procedures performed in the U.S. involve bone void filling, also known as bone grafting, and such procedures are most commonly required for spinal fusion, trauma, and revision total joint replacement procedures.

Anika estimates the current market size for treating tibial plateau fractures, stress fractures around joints, and decompression of necrosed bone to be around $300 million.

While the use of autologous bone or autograft has been the gold standard of treatment for bone grafting, the increased risk of procedural complications has prompted a shift towards alternate treatments1, such as synthetic, resorbable bone graft substitute materials.
________________________________________________________

1 Marc Bohner, Resorbable biomaterials as bone graft substitutes, In Materials Today, Volume 13, Issues 1–2, 2010, Pages 24-30, ISSN 1369-7021, https://doi.org/10.1016/S1369-7021(10)70014-6. (http://www.sciencedirect.com/science/article/pii/S1369702110700146)

(Source: Anika Therapeutics, Inc.)


Filed Under: Industry regulations

 

Related Articles Read More >

ids-industrial-camera-manufacturer.sustainability-3
IDS focuses on sustainability in shipping
Part 5: Motion control + MQTT, OPC-UA, and other protocols for cloud services
Facebook CEO Zuckerberg Calls for More Outside Regulation
Musk’s Boring Company Calls it Quits on LA Tunnel, Instead Focuses on Hyperloop

DESIGN GUIDE LIBRARY

“motion

Enews Sign Up

Motion Control Classroom

Design World Digital Edition

cover

Browse the most current issue of Design World and back issues in an easy to use high quality format. Clip, share and download with the leading design engineering magazine today.

EDABoard the Forum for Electronics

Top global problem solving EE forum covering Microcontrollers, DSP, Networking, Analog and Digital Design, RF, Power Electronics, PCB Routing and much more

EDABoard: Forum for electronics

Sponsored Content

  • Renishaw next-generation FORTiS™ enclosed linear encoders offer enhanced metrology and reliability for machine tools
  • WAGO’s smartDESIGNER Online Provides Seamless Progression for Projects
  • Epoxy Certified for UL 1203 Standard
  • The Importance of Industrial Cable Resistance to Chemicals and Oils
  • Optimize, streamline and increase production capacity with pallet-handling conveyor systems
  • Global supply needs drive increased manufacturing footprint development

Design World Podcasts

June 12, 2022
How to avoid over engineering a part
See More >
Engineering Exchange

The Engineering Exchange is a global educational networking community for engineers.

Connect, share, and learn today »

Design World
  • Advertising
  • About us
  • Contact
  • Manage your Design World Subscription
  • Subscribe
  • Design World Digital Network
  • Engineering White Papers
  • LEAP AWARDS

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Design World

  • Home
  • Technologies
    • 3D CAD
    • Electronics • electrical
    • Fastening & Joining
    • Factory automation
    • Linear Motion
    • Motion Control
    • Test & Measurement
    • Sensors
    • Fluid power
  • Learn
    • Ebooks / Tech Tips
    • Engineering Week
    • Future of Design Engineering
    • MC² Motion Control Classrooms
    • Podcasts
    • Videos
    • Webinars
  • LEAP AWARDS
  • Leadership
    • 2022 Voting
    • 2021 Winners
  • Design Guide Library
  • Resources
    • 3D Cad Models
      • PARTsolutions
      • TraceParts
    • Digital Issues
      • Design World
      • EE World
    • Women in Engineering
  • Supplier Listings