CoreLink, LLC, announced 510(k) FDA clearance on September 24, 2019 for its Oro™ Lateral Plate System.
FDA Clears CoreLink’s Lateral Plate System
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The company says the system is “the only lateral plating system on the market with the flexibility to be used as supplemental fixation in multiple scenarios, including optional permanent connection to CoreLink F3D or CL5 Lateral interbody devices.”
Indications
The FDA clearance document says the CoreLink LPS system is intended “for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.”
“The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1S1) fixation for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, deformities or curvatures, tumor, pseudoarthrosis, and failed previous fusion.”
“Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS must only be used to treat patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.”
The system is “comprised of a lumbar plate and screws. The lumbar plate has a sliding, spring loaded lock tab for each screw position to prevent back-out of the screw. The plate is available in a 2-screw or 4-screw version and in multiple lengths for single level fixation. The screws are available in various lengths and 2 diameters.”
Company CEO Jay Bartling said since the plate can be attached the CoreLink Lateral interbody devices on the back-table or in-situ, “it can both provide additional stability, and facilitate plate placement.”
The company press release stated that most other lateral plating systems on the market “are indicated as supplemental fixation, and lateral interbody devices with integrated fixation are indicated to be used with additional supplemental fixation, such as posterior pedicle screws. The products that CoreLink has introduced bridge the gap between these two types of indication statements giving surgeons more options for on-label treatment of patients with the lateral procedure.
The company will be exhibiting at the Congress of Neurological Surgeons Annual Meeting in San Francisco at booth #449. The meeting runs from October 19-23, 2019.
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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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