FDA 510(k) clearance for Vault-C anterior cervical interbody fusion device


Precision Spine has received 510(k) clearance and initiated the launch of its Vault-C anterior cervical interbody fusion device. The company says that the device represents a significant addition to its cervical product portfolio and joins an array of recently introduced advanced spinal solutions from the company. It adds it also offers the versatility so highly sought after by surgeons.

The plate/cage integrated design allows for rigid screw fixation using a zero profile construct—the zero profile design limits the risk of damage to surrounding vessels and adjacent soft tissue, while the large, open bone graft area allows for optimal graft containment. With two options for screws, self-drilling/self-tapping and blunt-tip/self-tapping—according to a press release—the surgeon has greater intraoperative flexibility and available thread purchase. The implant’s integrated locking mechanism is designed to prevent screw backout while enabling visual confirmation. The Vault-C is available in various heights and geometric footprints to accommodate individual patient anatomy and desired graft material sizes. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

It is a stand-alone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Fabian Bitan, director of Spinal Surgery Services at Lenox Hill Hospital, New York, USA, comments: “I believe that the Vault-C represents a significant innovation over existing stand-alone devices. First, it is a two screw system, enabling the required stability and decreased surgical time, and with several available footprints, it accommodates varying patient anatomy. Secondly, its instrumentation strikes a balance between modularity and simplicity, with options to satisfy various surgeon preferences. I feel that the Vault-C builds on the strengths of existing devices while effectively addressing their flaws and weaknesses.”