Some spine patients need stability of their spinal column even in the absence of fusion. That’s because their life expectancy is limited and don’t have time for fusion.
No Time for Fusion, But Need Stability?
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#fda510kclearance#strykerSecondary#fusion
Continuing to address this need, Stryker Corporation’s spine division recently announced an expanded indication for its Capri Expandable Corpectomy Cage System.
Capri Expandable Corpectomy Cage System
The system, according to the company, is used to “replace diseased or damaged vertebral body and stabilize the spine in cases of vertebral body resections caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.”
The system, first introduced in 2017 by K2M, Inc., was the world’s first and only 3D-printed expandable device on the market to facilitate continuous in-situ height expansion and endplate angulation in the cervical spine.
The purpose of the company’s recent FDA 510(k) submission was to introduce a new 12X14mm cervical expandable footprint size to the previously cleared system. It took the FDA about eight months to grant clearance in late February.
Lamellar 3D Titanium Technology
The company says the system features Lamellar 3D Titanium Technology. The technology incorporates 300-500 μm longitudinal channels, which in conjunction with transverse windows, “create an interconnected lattice designed to allow for bony integration.” The system is offered in various footprint options, allowing for in-situ height expansion and endplate angulation.
The Cage
The corpectomy cage, according to the company, is designed for an anterior cervical approach. Continuous in-situ adjustment is designed to allow for the corpectomy cage to be locked at the desired height and lordotic angulation within the expansion range of the implant via the locking set screw.
Roughened titanium surfaces are designed to increase protein expression in contrast to smooth titanium surfaces and are offered in 12x14mm, 13x16mm and 14x18mm footprints.
FDA Indications
According to FDA clearance documents, the cages are intended to “restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.”
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
When used in the cervical spine at one or two levels, the cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
Video
Check out a cool animated company video of the system here.
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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.
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