NEW TECHNOLOGY UPDATE
São Paulo, Brazil-based BioArchitects has announced U.S. Food and Drug Administration 510(k) clearance of its
3D-printed, patient specific, titanium cranial/craniofacial plate implant. Designed for
the repair of defects in the non-loadbearing
bones of the head and face, each custom
designed plate is permanently attached to
the skull and/or face with self-tapping titanium screws.
The device makes use of 3D printing
technology from Arcam AB, taking advantage of the properties of light weight and
high tensile strength of the biocompatible
titanium alloy made from Arcam’s electron
beam melting (EBM) technology.
“We are proud to contribute to what
we consider another major advance in
the trend toward personalized medicine.
We believe this is yet another step toward
what will ultimately become the new
standard of care,” said Mark Ulrich, CEO
of BioArchitects USA.
Devices of this kind are typically used
in the repair of bony defects resulting from
trauma, disease, or congenital abnormali-
ties. As each device is specific to a single
individual, its construction begins with the
taking of a computed tomography (CT)
scan or medical resonance imaging (MRI)
of the affected area. The scan or image is
then imported into a highly sophisticated
computer design program, which is used to
create a template of the repair that becomes
the model from which the 3D printer pro-
duces the titanium plate to the specific di-
mensions of the design. The resulting plate
is an exact fit for the defect, not unlike the
positioning of a jigsaw puzzle piece. Get-
ting from CT scan or MRI, the finished
plate is the end product of collaboration
between the surgeon and the biomedical
engineer responsible for the design.
“BioArchitects is an example of how
organizations are using EBM technology to advance biomedical surgeries that
truly affect people’s lives,” said Magnus
Rene, CEO of the Arcam Group. “Arcam
has been a strategic supplier to the orthopedic market for over a decade and tens
of thousands of implants are made yearly
from our EBM systems.”
CE Mark for K2M’s Next-Generation
RHINE Cervical Disc System
Leesburg, Va-based K2M Group Holdings Inc. has received a CE Mark for the
RHINE Cervical Disc System, the company’s next-generation cervical artificial disc
replacement featuring proprietary molding technology.
The RHINE Cervical Disc System features a one-piece, compressible polymer
core design with dome-shaped, plasma-coated endplates and a central-split keel.
Proprietary molding technology is incorporated to minimize wear between the
polymer core and metal endplates.
“The RHINE Cervical Disc System is
manufactured through a proprietary over-
molding process of elastomeric polymer
that differentiates the system from the
competitive offering,” said Dr. Casey Lee,
orthopedic surgeon and principal inventor
of the RHINE Cervical Disc System. “We
are committed to showing successful clin-
ical results and are initiating a prospective
observational clinical study in multiple
sites throughout Europe.”
The system’s streamlined instrumen-
tation simplifies the surgical technique by
integrating trialing and keel cutting into
one instrument. A built-in adjustable stop
allows for customized anterior or poste-
rior positioning of the disc based on sur-
“The RHINE Cervical Disc System was
FDA Clears Fusion Implant System
developed through collaboration with
a global surgeon design team,” said Dr.
Richard Guyer, orthopedic surgeon, co-
founder of the Texas Back Institute, and di-
rector of the Spine Fellowship Program in
Roanoke, Texas.“The one-piece compress-
ible polymer core design performed well
in biomechanical testing when compared
to the natural cervical disc.”
The first single- and multi-level surgi-
cal procedures using the RHINE Cervical
Disc System were completed in Belgium
and Germany. Additionally, enrollment for
a prospective, observational RHINE Cer-
vical Disc Clinical Study will begin in the
first quarter of 2016. Primary objectives of
the study are to obtain operative data and
feedback; confirm device performance;
and collect radiographic data and clinical
outcomes. An estimated 166 participants
are expected to be enrolled in the study.
from Bio2 Technologies
Bio2 Technologies Inc. of Woburn, Mass.,
has received 510(k) clearance from the U.S.
Food and Drug Administration for its fusion implant system for interphalangeal fusion, fracture repair, and osteotomies of the
toes, fingers, and other small bones in the
presence of appropriate immobilization.
The implants are constructed with
Bio2’s Vitrium biomaterial exclusively
composed of bioactive glass, a resorbable
material with a well-studied mechanism
of action and long track record of safe
clinical use, according to the company.
Following years of research and preclinical
testing, Bio2 has successfully applied its
proprietary process technology to produce
FDA Clears Bioarchitects’ 3D Printed Titanium Cranial Plate
3D-printed patient-specific cranial/craniofacial
plate implant. Photo courtesy of BioArchitects.