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K2M new 3D printed titanium implant system is eligible for FDA access

Author : Date : 6/11/2016 7:56:53 PM
 June 1st, 2016, a global medical device company K2M received from the US Food and Drug Administration (FDA) on its two 3D printing solutions for spine --CASCADIA Cervical and CASCADIA AN Lordotic Oblique the 510 (K) formal approval letter. It is reported that the two solutions while taking advantage of K2M Lamellar 3D Titanium Technology, it can be implemented throughout the implant "osseointegration."

 

It is understood, K2M 3D printing implants were gill-like arrangement, the layered structure can mimic real human skeleton, as with traditional casting technology can not be completed. It first carefully CAD design, then use the 3D printer to print out the metal. Each CASCADIA implants are made of high-energy laser beam melting of titanium metal powder made, culminating in the exact layered porous structure with a surface roughness 3-5μm. Now, thanks to FDA approval, more patients can enjoy the benefits of this unique technology, the increasing material manufacturing.

 

Approved two new products will CASCADIA separately for different patients, cervical interbody fusion system as an interbody device that can provide stability and support for the cervical spine; and another oblique interbody lordosis system, compared with surgical the doctor provides an inter-body design for a series of automated with transforaminal lumbar vertebra oblique method of placement. Both systems can be used for autologous or allogeneic bone tissue transplantation, these organizations can be used to treat degenerative disc disease (DDD) and degenerative scoliosis.

 

After obtaining the approval of the FDA, K2M's CASCADIA between cervical nerve systems have Tom Morrison in surgeon was the first application in Atlanta Polaris spine and neurosurgery center. "I am delighted to be layered 3D technology for titanium spine, it reaches a good smooth roughness and porosity, it can make bones grow on the implant." Morrison said: "In addition, CASCADIA implant similar biomechanical stiffness polyether ether ketone (PEEK), less than the more conventional solid titanium design. "

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