Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Consumer Information on: DePuy Ceramax Ceramic Total Hip System – P070026S004

April 24, 2013 By U.S. Food & Drug Administration

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: DePuy Ceramax Ceramic Total Hip System
PMA Applicant:
DePuy Orthopaedics, Inc.
Address: 
P.O. Box 988, 700 Orthopaedic Drive, Warsaw, Indiana 46581-0988
Approval Date: 
April 2, 2013
Approval Letter:
http://www.accessdata.fda.gov/ cdrh_docs/pdf7/p070026s004a.pdf

What is it? The Ceramax Ceramic Hip System is a ceramic-on-ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint.

How does it work? The Ceramax Ceramic Hip System consists of:

  • A metal hip stem that a doctor places into a hole drilled in the end of the thigh (hip) bone (femur).
  • A Biolox delta ceramic, ball-shaped part (femoral head) that attaches to the hip stem.
  • A metal, socket-shaped part (acetabular shell) implanted into the pelvis that the ceramic insert fits into.
  • A Biolox delta ceramic insert that fits into the acetabular shell.

The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move.

When is it used? The Ceramax Ceramic Hip is used in patients who need replacement of a hip joint that is painful or cannot function because of arthritis, injury, or dislocation.

What will it accomplish? The Ceramax Ceramic Hip System relieves pain and allows for increased function in the hip.

When should it not be used? The Ceramax Ceramic Hip System should not be used in patients in the following situations:

  • Skeletally immature patients (tibial and femoral epiphyses not closed);
  • Evidence of active infections that may spread to other areas of the body including osteomyelitis, pyogenic infection of the hip joint, overt infection, and urinary tract infection;
  • The presence of any known tumor-causing (neoplastic) or cancer that has spread (metastatic disease);
  • Significant neurologic or musculoskeletal disorders or diseases that may adversely affect walking (gait), weight bearing or postoperative recovery including muscular dystrophy and multiple sclerosis;
  • Presence of highly communicable disease(s) that may limit follow-up visits including immuno-compromised conditions, hepatitis, and active tuberculosis;
  • Any condition that may interfere with postoperative recovery including Paget’s disease and Charcot’s disease;
  • Inadequate bone stock to support the device including severe osteopenia or osteoporosis;
  • Poor skin coverage around the hip joint;
  • Known allergies to the implant materials;
  • Marked muscle and/or tissue loss (atrophy) or deformity in the upper femur such as a birth defect affecting the leg bones;
  • Inflammatory degenerative joint disease, such as rheumatoid arthritis;
  • Joint instability

Additional information:  The Summary of Safety and Effectiveness Data and labeling are available online.

Other Resources:

  • NIH-MedlinePlus – Hip Injuries and Disorders
  • American Academy of Orthopaedic Surgeons – Activities After Hip Replacement

Related Articles Read More >

Verily Study Watch
Verily says its Study Watch could identify heart failure risk
A child using a medical device at home.
Device design takes the spotlight among 2024’s top health tech hazards
These 11 medical device inventions are the best of 2023, Time magazine says
A photo of a Best Buy Geek Squad employee helping a chronic care patient with a remote monitoring device.
Device manufacturers have an unexpected ally for at-home health care
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 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 LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe