Minimally invasive spine specialist K2M Group Holdings, Inc., well known to our pages for its devices to address complex spine disorders, tells us it has gained U.S. FDA 510(k) clearance for its CASPIAN® Occipital Anchor Spinal System. The news is accompanied by the announcement that the company is introducing the SERENGETI® Minimally Invasive Retractor System in Japan, and launching its CAYMAN® Minimally Invasive Plate System in the United States, Australia and the United Kingdom.
Background
The FDA clearance of the CASPIAN Occipital Anchor marks the latest addition to K2M’s complex spine portfolio, providing surgeons, specifically those in the neurosurgical community, with an anchor that allows for fixation behind the occiput, anchoring posterior cervical and thoracic constructs to the spine. The system provides a strong alternative to mid-line fixation and allows for flexible implant positioning to accommodate varying patient anatomy. K2M’s MESA® Mini and DENALI® Mini systems are compatible with CASPIAN Occipital Anchor.
The company is also continuing the global expansion of its minimally invasive technologies with the introduction of SERENGETI Retractor in Japan. Serengeti’s flexible polymer Retractor provides direct visualization and access to the screw heads to allow for simplified rod insertion. The Retractor is inserted with the screw, allowing for one-step, percutaneous placement of the implants.
Finally, the UK launch of CAYMAN Minimally Invasive follows K2M’s first quarter release announcing FDA 510(k) clearance. The plate’s single-level, stackable design allows for one-level and multi-level constructs. The low-profile, four screw construct features K2M’s proprietary tifix® Locking Technology, a plate-screw locking technology whereby each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism. CAYMAN Minimally Invasive is specifically designed for insertion through the RAVINE® Lateral Access System, allowing surgeons to preserve the position of the lateral implant and insert the plate without repositioning the RAVINE Retractor.
Physician comments
“CASPIAN Occipital Anchor is a good option for occipital fusions,” stated Faheem Sandhu, MD, PhD, Professor of Neurological Surgery and Director of Spine Surgery at Georgetown University Hospital. “The low-profile system helps to maximize the amount of occipital bone for fusion and will be a strong alternative to plate systems, where hardware often obscures the occipital bone.”
According to Thomas Reilly, MD, an orthopaedic spine surgeon at Indiana Spine Group, “The CAYMAN Minimally Invasive Plate allows for the application of low-profile anterior instrumentation after placement of the lateral interbody without having to significantly modify the typical minimally invasive approach. For appropriate patients, this enables use of a stable, stand-alone lateral construct.”
Company comments
“These highlights reaffirm K2M’s continued commitment to evolving and expanding our technologies, specifically in the areas of complex spinal pathologies and minimally invasive procedures,” stated Eric Major, K2M’s President and CEO.
Source: K2M Holdings, Inc.
