Spineart now has the green light from the FDA, with prized 510(k) clearances to market its new JULIET Ti lumbar interbody systems. As indicated in the July 18, 2016 news release, “The JULIET Ti PO, OL and TL interbody systems are the first range of titanium interbody implants benefiting from the company’s proprietary Ti-LIFE Technology. The Ti-LIFE Technology micro-porous scaffold mimics the bone trabecular structure and features interconnected pores of 600 μm to 700 μm and an overall porosity of 70-75% designed to enable cell colonization and promote bone in-growth2. This technology is based on a unique algorithm associated with a state-of-the-art additive manufacturing process, often referred to as 3D printing. The JULIET Ti interbody systems for PLIF, OLIF and TLIF techniques include a full range of sizes to address different anatomies as well as an insert-rotate option. The smooth bullet-shaped nose, lateral sides and chamfers of the implant are polished to preserve endplates, nerve roots and soft tissues during insertion. The JULIET Ti design features an overall reduced density to optimize the imaging performances.”
Spineart: Clearance to Market Interbody Devices
The company states that the instrument set is ultra-compact and features multi-functional instruments. All Spineart implants, including the entire JULIET Ti range, are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency.
Jerome Trividic, COO of Spineart, told OTW, “Additive manufacturing also referred to as 3D printing produces highly cohesive device which differentiates Spineart’s Ti-LIFE Technology from non-porous surface treatments and coating techniques. The goal of our micro-porous scaffold is to mimic the cancellous bone structure. It features interconnected pores with a diameter of 0.6 to 0.7mm to enable cell colonization and an average of 70 to 75% of overall porosity for imaging performance. The geometry created with Spineart’s Ti-LIFE Technology would simply not be possible to achieve through classic manufacturing processes.”
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.