FDA Clearance for Signus Mobisc® II ST interbody fusion device

SIGNUS Medizintechnik, the German developer and manufacturer of spinal implants, has received FDA clearance to commercially release
its Signus MOBIS ® II ST system, which is comprised of a line of structural titanium interbody devices placed through a Transforaminal Lumbar Interbody Fusion (TLIF) approach. This new implant will join the previously cleared MOBIS® II PEEK implants which utilise the same instrumentation.

Uwe Siedler, President SIGNUS, said “We are all extremely pleased with this most recent FDA clearance, the first of many more to come, in our unique ST Line™. It heralds the first real advancement in this type of implant design and production. The ST Line™ implants have a 3-dimensional framework designed to improve the ingrowth and ongrowth of bone through the entire implant. MOBIS® II ST is actually 70% porous and allows intimate contact of bone not only on the surface of the implant but through it as well.”

Thomas Hoghaug, President SIGNUS Medical, LLC said “The introduction of the ST Line™ into the United States will provide spinal surgeons with a superior alternative to other titanium implants currently being marketed. The biocompatibility of titanium is long proven and to now offer an implant comprised mostly of an open lattice structure for bony incorporation, without sacrificing implant design and integrity, is extremely exciting.” Hoghaug further commented, “The implant, in addition to being manufactured from the advanced
ST material, has improvements in design, access, placement and maneuverability over other traditional TLIF implants now commercially available. The entire MOBIS® II System includes a PEEK-OPTIMA® version as well, utilizing a single set of instruments, thus giving surgeons implant options based upon patient needs.”