The U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for implants which restore the integrity of the spine in tumor and infection cases.
According to the FDA documents, the first system is indicated to “provide the surgeon with a minimally invasive and open approach for posterior spinal surgery,” and is further intended to “restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.”
When used in conjunction with certain bone cement or devices for mixing and injecting bone cements, the pedicle screws are intended to “restore the integrity of the spinal column even in the absence of fusion for a limited time.” The fenestrated pedicle screws augmented with bone cement are for use at “spinal levels where the structural integrity of the spine is not severely compromised.”
The first system is intended to “stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.”
All of the devices were submitted for 510(k) clearance by icotec ag. icotec develops implants for the treatment of spinal tumors and spinal infections. The first system is the VADER® Pedicle System.
The second 510(k) clearance is for the following two systems: KONG®-C VBR System and KONG®-TL VBR System.
According to FDA documents, both systems are made of BlackArmor® material, “a carbon fiber reinforced polyetheretherketone (Carbon/PEEK) composite.” According to the press release, the BlackArmor implants offer “reduced artifacts from radiolucent Carbon/PEEK material, which enables improved imaging in the post-operative setting as well as in the monitoring of infection.”
The KONG-TL VBR System devices are intended for “use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).” When the system is used with the VADER Pedicle System, it is intended to “stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.”
The KONG-C VBR System devices are intended for “use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body 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.” When the system is used with the icotec Anterior Cervical Plate System, it is intended to “stabilize the cervical (from C2 to T1) spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.”
About PUSM
Shenyang Pusm Medical Equipment Co., Ltd. was established in 2006. It is a professional enterprise integrating R & D, manufacturing and sales. It specializes in producing medical equipment according to national standards. Our company's main products: medical electric saw drill series; imported brushless motor series; domestic high-quality brushless motor series; medical electric drill pendulum saw integrated multi-functional system; hand, foot and ankle special system; pedicle screw screwing into special power; external fixed needles are screwed into special power; external fixation series; bone cement cannula; bone cement guns and other orthopedic surgical instruments.
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