The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for US-based implant development firm Moirai Orthopaedics to begin the clinical trial of its Pyrocarbon Implant Replacement (PIR) system.

Developed in collaboration with US-based Fellowship of Orthopaedic Researchers, the PIR System secured CE Mark in August 2013.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The patented PIR System is a single-component implant fabricated from On-X pyrolytic carbon, with hydroxyapatite coating on all bone interfacing surfaces.

The company plans to start the clinical trial of the system this summer, with the first implantations carried out by New Orleans’s Ochsner Sports Medicine Institute section head of Sports Medicine Dr Deryk Jones.

"The patented PIR System is a single-component implant fabricated from On-X pyrolytic carbon, with hydroxyapatite coating on all bone interfacing surfaces."

Dr Jones said: "The PIR System has the potential to address an important unmet clinical need and we have been anxiously awaiting the start of the study."

See Also:

The trial is designed to evaluate the safety and effectiveness of the PIR System in the treatment of articular cartilage defects (Outerbridge Grade III or IV) of the medial femoral condyle compared to control treatment.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company said the targeted indication is for treatment of symptomatic cartilage defects of the anterior or central medial femoral condyle in patients who had an inadequate response to prior conservative treatment or previous arthroscopic debridement and lavage.

The system is designed for younger patients who are in need of total knee replacement (TKR) or either poor candidates for or those unable or unwilling to devote the necessary rehabilitation time for cartilage regenerative procedures.

Currently, the PIR knee system is limited to investigational use in the US.

The company said the investigational PIR implant is placed as a hemi-arthroplasty through a minimally invasive surgical approach and articulates with the native tibia cartilage.