ConforMIS customisable total knee replacement
system wins FDA clearance
21 Feb 2011
US company ConforMIS has received US FDA clearance to market
its iTotal CR knee-replacement system, a patient-specific system 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 patient’s 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.
Individualized
implant surface generation during design of an
iTotal CR femoral
component (photo: Business Wire).
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 total knee
replacement. The design
software generates medial and lateral articulating surface
geometries for each patient that more closely mimic a patient’s
natural geometry while correcting for deformity.
“The ability to give patients a long lasting, natural feeling
knee has been the holy grail of orthopaedics 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 iTotal system will be available in limited release to a
select group of surgeons in 2011.