3D-printed implants for cervical spinal surgery
The first and second US clinical use of a 3D-printed cervical interbody system for cervical spine surgery has been reported.
ZSFab (MA, USA), a 3D-printing medical device company, has reported the successful application of their Cervical Interbody System for anterior cervical discectomy and fusion (ACDF) in two US clinical cases. ACDF is a surgical procedure that relieves cervical spine and neck pain arising from a damaged or herniated disc. In the procedure, a cervical interbody system can be utilized to support the fusion of two vertebrae following the removal of the damaged disc.
The system, which received FDA 510(k) clearance in 2021[1], consists of a porous 3D-printed titanium implant with a triply periodic minimal lattice structure that distributes stress evenly and reduces the risk of subsidence into surrounding tissue. The implant also has rigid teeth on the inferior and superior surfaces that help stabilize the system following implantation and maximizes the contact area with the vertebrae endplates.
The company collaborated with orthopedic surgeons based in Oklahoma to perform the procedure. The first clinical application in the US was conducted by Fernando Villamil, an orthopedic surgeon at the Center for Orthopedic Reconstruction and Excellence (OK, USA)[2]. Within a week of the first procedure, a second procedure was performed by Jeffery Moore based at the Surgical Hospital of Oklahoma (OK, USA)[3].
Fernando Villamil commented: “The design of the ZSFab Cervical Interbody device allows for bony ingrowth with its optimized lattice throughout and for generous biologic material placement, without sacrificing strength or subsidence performance.”
Before its initial use in clinical cases in the US, the ZSFab Cervical Interbody System had already been successfully utilized in clinical cases in China for ACDF.
In response to the first clinical application of the cervical interbody, Jing Zhang, CEO of ZSFab commented: “We are thrilled to have our first ZSFab cervical interbody implanted by Dr. Villamil. The device is designed with interconnected porous structures, engineered for bony integration, minimal debris, high fatigue strength, and minimized subsidence. As we expand our spine solutions, our team is dedicated to providing products of the highest quality to improve patient outcomes with shortened recovery time and reduced revision rates.”
ZSFab has stated that the device is available in a range of sizes, making it feasible for a number of ACDF procedures.