The FDA has expanded Titan Spine’s Endoskeleton TA Vertebral Body Replacement Device (VBR) 510k to include an Interbody Fusion Device indication.
Under its expanded 510k indication, the Endoskeleton device is approved for use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2–S1.
“This is an important step for Titan Spine as it gives the surgeon the ability to utilise the Endoskeleton TA as an Interbody Device while taking off the VBR label, as well as the ability to feel comfortable knowing that they now have the option to use the device in a stand-alone setting,” said Steve Cichy, Vice President of Sales.
Titan Spine expects that this new product indication will increase product adoption among a group of surgeons that are focused both on technique proficiency and positive, predictable outcomes for their patients.
The Endoskeleton TA is a Titanium cage that sits on the strongest portion of the lumbar endplate, yielding excellent resistance to subsidence and expulsion. Coupled with a large open area for bone graft, the device’s acid-etched Titanium surface serves to provide a strong press fit and boney ingrowth.