SeaSpine receives two US FDA 510(k) clearances


SeaSpine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Shoreline ACS anterior cervical standalone system, featuring TruProfile technology, and its Mariner posterior fixation system.

TruProfile offers a low profile plate designed to minimise cephalad-caudal encroachment onto the vertebral bodies and maximise the distance from adjacent disc spaces.  The Shoreline ACS anterior plate is 1.6mm thick, intended to provide minimal profile on the anterior spine.

The system is designed to maximise intraoperative flexibility by offering a full complement of zero and low-profile plating options, including two-, three- and four-hole variations, as well as 10 degree lordotic implants.

The Shoreline ACS system incorporates proprietary NanoMetalene surface technology.  NanoMetalene interbody implants are designed to provide the benefits of a titanium surface while retaining the benefits associated with traditional PEEK devices.  NanoMetalene comprises a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-Optima polymer from Invibio. It is applied in a proprietary, high-energy, low-temperature process that differs from other coating applications and maximises implant surface area with titanium nanotopography.

The Mariner posterior fixation system is a pedicle screw system featuring modular threaded technology and accompanying instrumentation. Designed to reduce the number of trays needed for surgery, Mariner is intended to provide surgeons with multiple intraoperative options to facilitate posterior lumbar fixation. According to a company release, key market differentiators of the Mariner system include in-situ modularity, motion limiting heads and rod versatility with both 5.5mm and 6mm offerings.

“In today’s hospital environment, the key is to have as many options as you can for your patient without overburdening your staff,” states Douglas Orndorff, an orthopaedic surgeon based in Durango, USA.  “Mariner is versatile, yet simple to use. Ultimately, it lets me make intraoperative decisions seamlessly.”

Warren Yu, director of Spine Surgery at George Washington Hospital, Washington, DC, USA, comments “Mariner’s state-of-the-art instrumentation and modular screw design provide me with the broad selection of implant configurations that I need to address the challenging patient anatomy I see in my adult spine practice—from basic degenerative to complex deformity cases.”

SeaSpine will be conducting initial cases for both products through a limited launch over the next few months and expects a full commercial launch of both Shoreline ACS and Mariner in the first half of 2017.