Products & Implants

Products & Implants


C-Plus™ PEEK IBF System

C-Plus™ PEEK IBF Webbed

C-Plus™ is a PEEK interbody fusion system that offers multiple options and features designed to provide stability and anatomic restoration, facilitating fusion, when used with autogenous bone graft, in anterior cervical discectomy and fusion (ACDF) surgery.

PEEK-OPTIMA® from lnvibio® 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.

C-Plus™ PEEK IBF Webbed


    • Lordotic implant
    • Multiple footprints
    • Available in heights from 5 to 11mm
    • Large graft space
    • Highly visible x-ray markers
    • Made with PEEK-OPTIMA® from lnvibio® Biomaterial Solutions
  • Implants are supplied sterile. Instruments are supplied nonsterile. For sterilization instructions, please reference the package insert.

  • Cervical Interbody Fusion Device Indications

    When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) System is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks 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 Streamline OCT, SlimFuse, Cequence, PAC Plate, or Aspect Systems.

    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 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 (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 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 cervical 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.

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