FDA Clears Endoskeleton® TCS Device for Cervical Fusion with Integrated Fixation

Search Medlatest and you’ll find a significant Titan Spine presence. Now the spinal interbody fusion implant specialist has received U.S. FDA 510(k) clearance for its Endoskeleton® TCS, an interbody fusion device for the cervical spine with integrated fixation.

Background

Titan Spine is pitching at 95 percent of the interbody devices market, with the Endoskeleton® TCS representing the seventh offering. Like the full line of Endoskeleton® implants, the TCS utilizes Titan’s proprietary surface technology designed to participate in the fusion process by creating an osteogenic response to the implant’s topography.

Titan says its Endoskeleton® TCS device is designed for integrated fixation with two surface-enhanced screws that provide for immediate implant mechanical stability. The screws incorporate an anti-backout feature that do not lock the screws to the implant and allow up to 39 degrees of medial-lateral and 29 degrees of anterior-posterior angulation post-implantation. The design of the TCS is consistent with the rest of the company’s interbody device portfolio by allowing for endplate sparing and apophyseal fixation and the incorporation of large windows and large internal volumes to allow for significant bone graft packing, clear CT and MRI imaging, desired bone graft loading, and the ability to pack additional bone graft material within the device following implantation.

Company comments

Kevin Gemas, President of Titan Spine, commented, “We are proud to launch the Endoskeleton® TCS as the latest addition to our surface engineered interbody device portfolio that continues to challenge the status quo in the interbody fusion marketplace. Like the rest of our products, the TCS is designed to benefit patients by affecting their healing process where it matters most – at the cellular level. The roughened surface technology featured on the TCS is created through a proprietary process that has been shown to produce a superior environment for bone growth at the cellular level when compared to PEEK. In addition, it has several advantages compared to PEEK devices with titanium plasma spray (TPS) coated devices. Most importantly, our surface is created through a proprietary subtractive process rather than an additive coating, which eliminates the potential for delamination and/or particulate debris when compared to products with a PEEK-titanium interface.”

Physician comments 

TCS design team member and Director of Spine Surgery at The Spine Institute of Idaho, Boise, ID, Dr. Richard Manos, M.D. commented,;“I am excited to incorporate the TCS into my practice. I have long believed in the benefits of cervical fusion devices with integrated fixation and feel that the incorporation of osteogenic surface technology is an important innovation in these types of devices. And while it is true that the cervical spine is quite conducive to high fusion rates, the speed in which the patient heals, which begins at the cellular level, can no longer be ignored.”

Another contributor Paul Slosar, M.D., Chief Medical Officer of Titan Spine, performed the first surgery using the Endoskeleton® TCS this month and said; “The surgery went extremely well. The instrumentation was intuitive and easily allowed me to place the implant and screws exactly as intended. I was particularly pleased with the stability of the implant’s macro surface to prevent device movement during screw insertion. The TCS is a perfect complement to Titan’s robust and growing pipeline.”

Source: Business Wire

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