Synergy Biomedical, LLC, a developer of novel biomaterial products,
announced today that it has received 510(k) clearance from the US Food
and Drug Administration to market BIOSPHERE® PUTTY as a bone
graft extender for use in the posterolateral spine.
"We are very pleased to receive the expanded spine indication for
BIOSPHERE PUTTY," stated Dr. Mark Borden, Ph.D., President/CEO of
Synergy. "The expanded clearance will give spine surgeons access to a
next generation bioactive bone graft product that can be used in
challenging spine fusion surgery. The clearance will also allow us to
greatly expand our growing distribution network, and get the product
into more srgeon's hands."
Under its expanded indications, BIOSPHERE PUTTY is indicated only for
bony voids or gaps that are not intrinsic to the stability of the bony
structure. BIOSPHERE PUTTY is indicated to be gently packed into bony
voids or gaps of the skeletal system as a bone void filler in the
extremities and pelvis, and as a bone graft extender in the
posterolateral spine. These defects may be surgically created osseous
defects or osseous defects created from traumatic injury to the bone.
The product provides a bone void filler that resorbs and is replaced
with bone during the healing process.
BIOSPHERE PUTTY is Synergy's first bone graft product utilizing patented
bioactive glass spheres that have been shown to improve the bone healing
properties of bioactive glass. The product provides surgeons with a
moldable bone graft material that has the highest bioactive glass
content on the market.
About Synergy Biomedical, LLC
Founded in 2011, Synergy Biomedical is a privately-held medical device
company focused on bringing innovative biomaterial based products to the
orthopaedic and spinal markets. The Company's BioSphere Technology
represents a unique approach to advancing bone graft technology, and
improving bone healing and patient outcomes.
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