Life Science News

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will introduce the Tritanium Posterior Lumbar (PL) Cage, a 3D-printed intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease, at the American Association of Neurological Surgeons Annual Meeting April 30–May 4, 2016, in Chicago (booth No. 3611). The Tritanium PL Cage is manufactured …

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will introduce the Tritanium Posterior Lumbar
(PL) Cage, a 3D-printed intervertebral body fusion device that aids in
lumbar spinal fixation for patients with degenerative disc disease, at
the American Association of Neurological Surgeons Annual Meeting April
30–May 4, 2016, in Chicago (booth No. 3611).
The Tritanium PL Cage is manufactured with Stryker’s innovative additive
manufacturing process, also known as 3D printing. The cage is
constructed using Stryker’s Spine division proprietary Tritanium
technology, a novel, highly porous titanium alloy material designed for
bone in-growth and biological fixation.1 Stryker’s
3D-printing process allows for the creation of porous structures that
are designed to mimic cancellous bone, a type of spongy bone tissue.
“We are pleased to bring this technology advancement to spine surgeons
and their patients,” said Stryker’s Spine division President Brad
Paddock. “Stryker is a pioneer in 3D additive manufacturing, investing
nearly 15 years in research and development. Unlike traditional
manufacturing techniques, the flexibility of our 3D additive
manufacturing capabilities allows us to precisely engineer and produce
porous Tritanium devices. The Tritanium PL Cage is an exciting addition
to our growing suite of unique spinal products.”
“Spine surgeons need a cage that has the capability of bony integration
or bony in-growth, as well as radiolucency so that we can evaluate the
fusion long term,” said Dr. Wellington Hsu, M.D., Orthopaedic Surgeon at
Northwestern Medical Group. “Because Tritanium has favorable
radiographic capabilities, as well as the integrative surface
technology, that really in my opinion is what I would ask for from an
interbody cage.”
Implanted via a posterior approach, the Tritanium PL Cage is available
in a variety of widths, lengths, heights, and lordotic angles that can
adapt to a variety of patient anatomies. Its large lateral windows and
open architecture allow visualization of fusion on CT and X-ray, and its
solid-tipped, precisely angled serrations are designed to allow for
bidirectional fixation and to maximize surface area for endplate contact
with the cage. The Tritanium PL Cage also is designed to minimize
subsidence into the endplates.
The Tritanium PL Cage, which is produced at Stryker’s state-of-the-art
3D additive manufacturing facility, will be widely available to
orthopaedic and neurosurgeons in mid-2016.
Tritanium Technology
In lumbar spinal fusion procedures, advancement of bony fusion at the
target levels is at the cornerstone of a successful clinical outcome. In
an effort to enhance the bony in-growth potential of implants, the
scientific community has focused on porous metal implants in the hope of
establishing a material similar in structure and mechanical properties
to bone. Studies also have sought to understand which geometry and pore
size would provide an optimal environment for cells to attach and
multiply within this structure.2–4
Stryker’s Spine division conducted a pre-clinical animal study to
investigate the biomechanical performance and bone in-growth potential
of various lumbar interbody fusion implants utilizing different surface
technologies (including the Tritanium PL Cage). The study has been
accepted as a podium presentation at the NASS Annual Meeting being held
Oct. 26-29, 2016, in Boston.
Indications for Use
The Tritanium PL Cage is indicated for use with autograft and/or
allogenic bone graft comprised of cancellous and/or corticocancellous
bone graft when used as an adjunct to fusion in patients with
degenerative disc disease at one level or two contiguous levels from L2
to S1. Degenerative disc disease is back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies.
The degenerative disc disease patients may also have up to Grade I
spondylolisthesis at the involved level(s). These patients should be
skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium PL Cage may be used as an adjunct to fusion
in patients diagnosed with degenerative scoliosis. It is to be implanted
via a posterior approach and is intended to be used with supplemental
spinal fixation systems that have been cleared for use in the
lumbosacral spine.
About Stryker
Stryker is one of the world’s leading medical technology companies and,
together with our customers, we are driven to make healthcare better.
The Company offers a diverse array of innovative products and services
in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine
that help improve patient and hospital outcomes. Stryker is active in
over 100 countries around the world. Please contact us for more
information at www.stryker.com.
Editor’s note: For images, video footage, or animation of Tritanium
products and Stryker’s 3D additive manufacturing process, contact
Barbara Sullivan at 714/374-6174 or
bsullivan@sullivanpr.com.
A backgrounder about Tritanium and the Tritanium PL Cage also is
available.

References

  1. Project #43909: Tritanium Technology Claim Support.
  2. Bobyn JD, Pilliar RM, Cameron HU, Weatherly GC. (1980) The optimum
    pore size for the fixation of porous-surfaced metal implants by the
    ingrowth of bone. Clinical Orthopaedics and Related Research, 150,
    263-270.
  3. Webster TJ, Ejiofor JU. (2004) Increased osteoblast adhesion on
    nanophase metals; Ti, Ti6AI4V, and CoCrMo. Biomaterials, 25, 4731-4739.
  4. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds
    and osteogenesis. Biomaterials, 26, 5474-5491.

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