Burlington, Mass.- February 3, 2011 – ConforMIS
has received 510(k) clearance from the U.S. Food and Drug Administration to
commercially market its iTotal® CR Knee Replacement System. The iTotal CR is
the only true patient-specific system available for patients who would
traditionally receive a standard total knee replacement (TKR).
The iTotal CR builds on ConforMIS patented iFit®
technology for generating patient-specific implants and individualized jigs. As
with all ConforMIS implants, the system uses computer modeling to build a 3D
image of a patients knee from CT scans. That image then guides the proprietary
design and manufacture of not just the jigs, but the personalized implants that
resurface the patients articular surfaces.
The patient-specific process produces customized implants
with unparalleled advantages. Each iTotal CR is made to fit an individual
patient precisely without the under-sizing and overhang common with standard
systems. The ability to maximize coverage for each patient is combined with one
of the broadest implant contact areas in the industry, resulting in extremely
low polyethylene contact stress.
In addition, the iTotal CR is engineered to do more than
just greatly improve fit. Patient specific technology on the femur preserves
significantly more bone than a traditional TKR. The design software generates
medial and lateral articulating surface geometries for each patient that more
closely mimic a patients natural geometry while correcting for deformity.
“The ability to give patients a long lasting, natural
feeling knee has been the holy grail of orthopedics for decades,” said Wolfgang
Fitz, MD, a member of the surgeon design team. “A patient-specific total knee that
reconstructs the surface geometry of the condyles has the potential to create a
knee replacement that is as close to normal as it gets.”
“The iTotal 510(k) clearance marks a new phase in ConforMIS
leadership of the patient-specific category by expanding our product line to
address the full range of opportunities in the multi-billion dollar knee
market, the largest segment in orthopedics,” said Philipp Lang, MD, CEO of
ConforMIS. “In introducing the only true patient-specific total knee system, we
are creating opportunities for innovation that will dramatically change the way
patients and surgeons approach orthopedics.”
The commercial release version of the iTotal CR Knee
Resurfacing System was 510(k) cleared in early January 2011. The iTotal
system will be available in limited release to a select group of surgeons in
For more information on ConforMIS visit www.conformis.com.
About ConforMIS, Inc.
ConforMIS, Inc. is a privately-held company that develops and commercializes
medical devices for osteoarthritis treatment and joint damage. Its proprietary
intellectual property includes more than 250 patents and patent applications in
the areas of imaging software, image processing, implant design, surgical
techniques, instrumentation, and manufacturing, spanning knee, hip, shoulder,
spine, and small joints. ConforMIS knee implants and instrumentation are
designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery. All devices have been cleared by the US Food and Drug
Administration for marketing in the US. In 2009, ConforMIS was named a
winner of the Medical Design Excellence Awards, the premier recognition for
contributions and advances in the design of medical products, for its iUni and
iDuo resurfacing implants. Follow ConforMIS on Twitter at @ConforMIS
and become a fan on Facebook at www.facebook.com/ConforMIS.