Spinal Elements’ 3D Spinal Implant Cleared by FDA
The FDA has granted Carlsbad, Calif.-based Spinal Elements 510(k) clearance for its Lucent 3D-printed interbody spinal implant.
The implant features a bone graft chamber access lid that enables the surgeon to tightly pack a large amount of graft inside for fusion. Closing the graft chamber lid distributes the graft load and reduces subsidence by providing more surface area for fusion.
In 2005, Spinal Elements was among the first companies to obtain interbody device clearance from the FDA for the use of polyetheretherketone (PEEK), a biopolymer that is biocompatible, radiolucent and has a similar elasticity to bone.