K2M two 3D printed titanium implant systems have been approved by the FDA
On June 1, 2016, global medical device company K2M received a report from the US Food and Drug Administration (FDA) on its two 3D printed spine solutions - CASCADIA Cervical and CASCADIA AN Lordotic Oblique - 510 (K) official approval letter. It is reported that these two solutions also utilize K2M's layered 3D Titanium Technology, which enables "bone integration" of the entire implant.
It is well known that implants are a relatively important medical device in the medical field. They can be composed of a variety of materials, such as titanium, silicone, etc., and are used for a variety of medical and cosmetic purposes. Of course, medical innovations are rapidly evolving, and K3M's 3D printed spinal implants offer exciting new possibilities for doctors and patients. For example, compared to solid metal objects implanted in patients in the past, the current 3D printed implant is a specially designed porous structure that encourages bone growth throughout the implant. K2M's two 3D printed layered titanium technology products, which have just been approved by the FDA, provide such a rough surface and porous structure that allows bone growth.
Specifically, K2M's 3D printed implants are arranged in a braided shape that mimics the layered structure of true human bones and cannot be accomplished with any casting technique. It was first carefully designed and then printed using a metal 3D printer. Each CASCADIA implant is a high-energy laser beam that melts titanium metal powder to form a precise layered structure with a surface roughness of 3-5 microns. Now, thanks to FDA approval, more patients can enjoy the benefits of this unique additive manufacturing technology.
It is reported that the newly approved two CASCADIA products are for different patients. The cervical intervertebral system is used as an interbody fusion device to provide stability and support for the cervical spine. The other anterior oblique intervertebral system is The surgeon provides a series of automatically designed interstitial for the placement of the oblique vertebrae through the intervertebral foramen. Both systems can be used for autologous or allogeneic bone grafting, which can be used to treat degenerative disc disease (DDD) and degenerative scoliosis.
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