This article is more than 5 years old. Information may no longer be current.

Oxford Performance receives FDA clearance for first 3-D–printed, load-bearing polymeric implant

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Oxford Performance Materials has announced the FDA 510(k) clearance of the company’s SpineFab VBR implant system.

The new system is the first and only FDA-cleared, 3-D–printed, load-bearing polymer device for long-term implantation. This is Oxford Performance Material’s (OPM) third successful OsteoFab regulatory clearance, according to a company press release.

The SpineFab VBR system implants will be 3-D printed in 48 sizes using only biocompatible polymer and laser light. The implants will be made by OPM’s OsteoFab process, which combines the 3-D printing technology with OPM’s OXPEKK powder formulation to print the orthopedic and neurological implants.

The new implants are intended for use in the thoracolumbar regions of the spine to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma. The FDA cleared the implants after the device underwent extensive static and dynamic mechanical testing to assure it met load and fatigue requirement, according to the release.

Reference: www.oxfordpm.com.