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Omnia Medical’s Boxcar Vertebral Body Replacement received a second FDA 510(k) clearance for use in the cervical spine. This builds on a previous thoracolumbar indication received in 2017.
The device was created with product development and regulatory support from JALEX Medical using PEEK-OPTIMA™ Hydroxyapatite Enhanced polymer supplied by Invibio Biomaterial Solutions.
Boxcar is offered in two footprints; its height and lordosis are adjustable using spacers and endplates. A hollow center and holes accommodate autograft or allograft while encouraging the formation of new bone. The PEEK-OPTIMA HA Enhanced material fully integrates hydroxyapatite throughout the polymer, as opposed to coating its surface. This allows the biomaterial to lend the same clinical advantages of PEEK-OPTIMA Natural, such as radiolucency, stiffness similar to bone and durability. The enhancement of HA has been shown to improve bone apposition (the joining together of bone material) in a preclinical ovine model at four and 12 weeks. Further, HA Enhanced showed performance advantages in a preclinical sheep cervical spine model at six and 12 weeks.
Early clinical results with PEEK-OPTIMA HA Enhanced show solid fusions, dense bone apposition at six months and improvements in overall pain and neurological function.
Steve Anderson, Vice President of Marketing at Omnia Medical, said, “There is a limited number of 510(k) FDA-cleared cervical VBR products on the market, and for our company to gain the first approval for a PEEK-OPTIMA HA Enhanced cervical corpectomy device is a great achievement.”
Source: Invibio Biomaterial Solutions
