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OverviewDesign CharacteristicsSizesIndications for useOperative manualFDA Clearance Letter

The XYcor™ Spinal Implant is designed as a surgeon focused vertebral body replacement device; delivering ease of insertion without sacrificing structural support and graft volume or surface area as with traditional ALIF devices.

The XYcor™ Spinal Implant is specifically designed for low profile, minimally invasive implantation and is compatible with current MIS/MAST (Minimally Invasive Surgery/ Minimal Access Spinal Technique) access systems. The XYcor™ Spinal Implant is delivered via a minimal access posterior /posterolateral annulotomy that is no larger than that used for a standard discectomy. The implant is designed to restore and maintain biomechanical integrity throughout the thorastic and lumbar spine following vertebrectomy or corpectomy for patients with spinal tumors or fractures. The implant, together with supplemental rigid internal fixation, provides anterior, middle and posterior column support both immediately after surgery and for prolonged periods in the absence of bone fusions. The implant is a cross-limbed, expandable vertebral body replacement device manufactured from surgical grade titanium.

INDICATIONS

The XYcor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

CONTRAINDICATIONS

Contraindications include, but are not limited to, active systemic infection, localized or spinal infection; morbid obesity; signs of local inflammation; fever or leukocytosis; demonstrated allergy or foreign body sensitivity to any implant materials; any medical or surgical condition which would preclude or impede the potential benefit of spinal implant and/or spinal fusion surgery, which could include, but not be exclusive to, elevated erythrocyte sedimentation rate, unexplained inflammatory/disease processes, elevation of white blood cell count (WBC), marked left shift in the white blood cell count differential; distorted anatomy, due to congenital or remote posttraumatic/postinfectious abnormalities; conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication as this condition may limit the degree of obtainable correction and/or height restoration, the amount of mechanical fixation, and/or the quality of the bone graft); any case in which a bone graft and fusion technique or where fracture fixation is not performed or required; any operative case utilizing the mixing of dissimilar metals from different components; patients having inadequate soft tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any case not described in the indications; patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, smoking, occupation, or lifestyle may interfere with their ability to follow postoperative instructions and/or activity restriction guidelines and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.

WARNINGS, PRECAUTIONS AND POTENTIAL ADVERSE EFFECTS/COMPLICATIONS

Correct selection of the implant is important.

Mixing metals can cause corrosion. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc., which come into contact with other metal objects, must be made from like or compatible metals. Avoid coupling of stainless steel with XYcor™ Spinal Implants.

The potential for satisfactory anterior column support is increased by the selection of the proper size device. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing.

Implants can break when subjected to the increased loading associated with delayed union or nonunion. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to material fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.

To review contraindications, indications and warning click the following link: Indications for use (PDF)