Products & Implants

Products & Implants


Cross-Fuse® II PEEK VBR/IBF System

Cross-Fuse<sup>®</sup> II PEEK VBR/IBF System

Cross-Fuse® II is a second generation lateral PEEK VBR/IBF device. The Cross-Fuse II implant is offered in a variety of widths, lengths, heights and lordotic options, providing the ability to tailor treatment to a specific patient for a more efficient implant experience. The implant features graft containment ridges, anatomically designed teeth and anterior holes providing a strong foundation for proper fusion.

PEEK-OPTIMA® from Invibio® Biomaterial Solutions

Regulatory approvals vary by country. Therefore, we kindly ask you to contact the distributor in your region regarding availability of specific products, implants and / or instrumentation in your region.

Cross-Fuse<sup>®</sup> II PEEK VBR/IBF System


    • Anatomy matching tooth geometry to minimize device movement
    • Graft window containment ridges
    • Bulleted nose to aid in distraction and placement
    • Available in 14, 18, 22 and 26mm widths with multiple lordotic/coronal angles
    • Composed of PEEK-OPTIMA® from Invibio® Biomaterial Solutions
  • Implants are supplied sterile. Instruments are supplied nonsterile. For sterilization instructions, please reference the package insert.

  • Lumbar Interbody Fusion Device Indications

    When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, Cross-Fuse, and Cross-Fuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment.

    IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.

    Vertebral Body Replacement Indications

    When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, Cross-Fuse, and Cross-Fuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System, Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.

    Warnings

    One of the potential risks identified with this system is death. Other potential risks which may require additional surgery include:

    • Implant component fracture
    • Loss of fixation
    • Non-union
    • Fracture of the vertebrae
    • Neurological injury
    • Vascular or visceral injury

    The components of this device are manufactured from a radiolucent polymer and include either Titanium (Ti) alloy or Tantalum (Ta) radiographic markers. Mixing of implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons.

    No implant system can withstand the forces of sudden dynamic loads such as falls or other accidents.

    This system has not been evaluated for safety and compatibility in the MR environment. This system has not been tested for heating or migration in the MR environment. 

    The implants of this system are manufactured using non-metallic and metallic, nonferromagnetic materials, which are not considered to be a contra-indication to MRI scanning; however, due to the presence of metallic material, image artifact will occur and there is a risk of heat generation. Any patient with an implant should therefore be monitored carefully, both in the approach to the magnetic field and during the examination. If discomfort is experienced, MR exposure should be discontinued.

    Precautions

    The implantation of interbody fusion devices/vertebral body replacements and supplemental internal fixation should be performed only by experienced spinal surgeons with specific training in the use of this system as this is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting implant size and supplemental internal fixation.

    Interbody fusion devices and vertebral body replacements (regardless of the indication for which they are designated) are designed to withstand full load bearing until bony union of the spinal segment(s) normally occurs. To ensure loadbearing ability supplemental fixation is required with the use of this implant.

    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.

    These implants can break when subjected to the increased loading associated with delayed union or non-union. Typically, internal fixation devices are load-sharing devices which hold a fracture in alignment until healing occurs. If healing is delayed, or does not occur, an implant could eventually break due to fatigue. Loads produced by weight bearing and activity levels will dictate the longevity of the implant.

    The patient should understand that stress on an implant could involve more than weight bearing. In the absence of solid bony union, patient weight alone, muscular forces associated with moving, or repeated stresses of apparent relatively small magnitude, can compromise the implant. Patients should be fully informed of these risks prior to and following surgery.

    Check packaging of sterile products. For product that is provided sterile, do not use if sterile package has been opened or damaged. If sterile package has been opened or damaged, return the implant to Pioneer Surgical.

    Correct handling of the implant is extremely important. Notches or scratches put in the implant during the course of surgery may also contribute to breakage. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Surgical implants must never be reused. An explanted implant should never be reimplanted. Even though the implant appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage.

    After implantation of an interbody fusion devices/vertebral body replacements and identification of the presence of fusion, only the supplemental fixation components should be removed.

    Certain degenerative diseases or underlying physiological conditions such as diabetes or rheumatoid arthritis may alter the healing process, thereby increasing the risk of implant breakage.

    Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.

    Interbody Fusion Device Contraindications

    Use of lumbar IBFs is contraindicated when there is an active infection at the operative site or with an allergy to polyether ether keytone, titanium, titanium alloy or tantalum; prior fusion at the level(s) to be treated; or any condition not described in the indications for use.

    Vertebral Body Replacement Contraindications

    1. Use of the Pioneer Surgical VBRs is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.
    2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopedic implant.
    3. Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these implants in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
    4. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant(s) during bony healing. These patients may be at a higher risk of implant fatigue, fracture, or dislocation.

    See product specific surgical technique manual and package insert for complete instructions and labeling limitations.