Paradigm Spine was granted supplemental FDA pre-market approval (PMA) for the coflex® Interlaminar Stabilization® disposable instrument kit. This marks the first approved disposable spinal instrument set for a Class III spinal device to receive a supplemental PMA.
Per FDA.gov, the supplement grants approval to introduce a kit of disposable instruments for coflex, and for Otto Klumpp to manufacture these disposable instruments in Germany. The kit will include a complete set of injection molded instruments delivered in a pre-sterilized peel pack, especially ideal for outpatient/ambulatory care settings.
coflex's original PMA was granted in 2012 for the treatment of moderate to severe stenosis with or without back pain.
Sources: Paradigm Spine, LLC; FDA.gov; ORTHOWORLD Inc.
Image courtesy of Paradigm Spine, LLC