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The First FDA-Cleared, 3-D Printed Facial Implant


Posted in Orthopedics by Chris Wiltz on August 21, 2014

 Oxford Performance Materials (OPM) has won a first-of-its-kind FDA clearance for its 3-D printed facial implant.


Every human face is unique. So why shouldn't facial implants be as well? It's a question South Windsor, CN-based OEM Oxford Performance Materials (OPM) has been tackling for almost a decade. And it's found its answer through additive manufacturing using 3-D printing. This week OPM announced FDA clearance of its OsteoFab Patient-Specific Facial Device (OPSFD), a 3-D printed, customizable implant for facial reconstruction. The 510(k) clearance is the first FDA clearance for a 3-D printed polymeric implant for facial indications and follows FDA's 2013 clearance of OPM's patient-specific cranial device polymeric implant.

The OsteoFab is a custom, 3-D printed implant for facial reconstruction. 
[image via Oxford Performance Materials]
Facial reconstruction can be a highly complex and demanding procedure, both for doctors and patients. Typically a surgeon will cut a metal material into an approximation of the shape a patient needs. It's a one-size-fits-all approach that isn't optimal for healing and recovery. “There has been a substantial unmet need in personalized medicine for truly individualized—yet economical—solutions for facial reconstruction,” says OPM's CEO Scott DeFelice. "Until now, a technology did not exist that could treat the highly complex anatomy of these demanding cases.” The OPSFD uses a patient scan, such as a MRI, to create an implant catered to their anatomy.
 
The key to OPM's approach lies in a poly-ether-ketone-ketone (PEKK) polymer called OXPEKK, a proprietary material developed by OPM. “We focus on 3-D printing as a process,” DeFelice says. “It's nice that you can make shapes and things with a 3-D printer, but it doesn't matter if they're not made of the right material.” OXPEKK's powder formulation allows OPM to used additive manufacturing to print implants that are not only patient-specific, but also biocompatible and mechanically similar to bone. “It's osteoconductive and offers a biological approximation, what we call biomimicry, so that bone grows onto and into the implant.” DeFelice says. The company says having a patient-specific implant available also decreases operation time, length of hospital stay, and reduces procedure complications.
 
Where 3-D printing always runs into challenges is when you begin to talk costs and economics. Creating customized implants can be a costly endeavor. Furthermore, doctors will often cite the time factor as a big turnoff. Even in creating 3-D printed models of patient organs, a patient must undergo a scan (which could be gigabytes in size) that then has to be converted into a 3-D printer-friendly format. Only after all of this does the printer begin the arduous task of additively printing the object. It's not ideal for emergency situations or even surgeries where timeliness is a factor.
 
However, OPM says that the Osteofab technology achieves its results without increasing manufacturing costs. We can make 30-50 custom cranial implants in a single production run,” DeFelice says. “From time of order to shipment is about five days. Normally, with these patient traumas, from the time the hospital is ready to take a scan we are way ahead of them.” The company adds that OsteoFab customers do not pay a premium for the individualized 3-D printed implant.
 
Orthopedics distributor Biomet will be the exclusive global distributor of the OPSFD. OPM says patient cases around the device are currently being developed.
 
Watch an overview of the OPSFD below:
 

 
 
-Chris Wiltz, Associate Editor, MD+DI
Christopher.Wiltz@ubm.com
 

 
Correction: A previous version of this article identified the OPSFD as being "approved." It was a clearance.
 

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follow-up

I was informed by OPM that (in their terminology) the 510(k) was "approved" but the device is "cleared". This appears to me to be a new construction of the use of approved and cleared as they pertain to a 510(k).

Approved?

Of course 510(k)s are not "approved", they are "cleared", a distinction reflecting the markedly different degree of scrutiny they receive. One might think that MD&DI would bother to get this right, regardless of what ODM's press release says. ODM seems to use the words interchangeably with one in the headline and one in the body, and switching which is which.