Biomedical Engineering Reference
In-Depth Information
This device is sold almost exclusively in the United States of America since the
United States FDA made approval of mobile bearing devices quite difficult. It
remained the only ankle replacement legally sold in the United States until the
PMA approval of the S.T.A.R.in 2009. The Agility was first implanted in 1984
although it was not available commercially until 1994.
e)
Others
Many other designs such as the Hintegra, ACS, TOPAZ (INBONE), BOX, Salto
and others, all of which are mobile bearing designs (except in versions modified
for sale in the United States of America [24]) have also been used clinically.
4.5.1.3 Third Generation Designs
a)
The B-P Meniscal Total Ankle Replacement Mark II
This design is a major redesign of the LCS Total Ankle Replacement. It uses a
much deeper sulcus and dual fin, rather than a central single fin talar fixation. This
dual fin arrangement is employed to reduce the risk of talar subsidence. The AP
dimension of the tibial plate is also significantly increased to provide greater bone
coverage [25].
Fig. 4.21
B-P Meniscal Total Ankle Replacement Mark II
