Products & Implants

Products & Implants


Streamline® MIS Spinal Fixation System

Streamline<sup>®</sup> MIS Spinal Fixation System Construct

The Streamline® MIS Spinal Fixation System allows a rigid construct to be created in the thoracolumbar spine via a percutaneous or mini-open approach using cannulated pedicle screws, set screws and rods. The system offers a broad range of implants and instruments, providing the ability to tailor treatment to a specific patient for a more efficient, streamlined, implant experience.

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.

Streamline<sup>®</sup> MIS Spinal Fixation System Construct


  • Cannulated Pedicle Screws

    • Polyaxial screws available in multiple diameters and lengths
    • Integrated, disposable and easily detached extension sleeves
    • Double lead thread design for faster implantation
    • Ti-6Al-4V

    Set Screws

    • Designed to reduce incidence of cross-threading
    • Use a standard T25 drive mechanism
    • Fit all screw sizes
    • Ti-6Al-4V

    MIS Rods

    • Standard Ø5.5mm pre-bent and straight rods available in multiple lengths
    • Ti-6Al-4V
  • This system includes components supplied both sterile and nonsterile. For sterilization instructions, please reference the package insert. 

  • Indications

    The Streamline® MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all of the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

    Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

    Warnings

    The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.

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

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

    The components of this device are manufactured from biocompatible implant grade materials. Mixing of certain implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons.

    No implant and screw 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.

    Precautions

    The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because 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 pedicle screw diameter and length. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants. Metallic 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 non-union. 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 metal fatigue. Based on fatigue testing results, when using the Streamline MIS Spinal Fixation System, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact the performance of the system. 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 bending, loosening, or breakage. Patients should be fully informed of the risks of implant bending, loosening, or breakage.

    Only rods and crosslinks are intended to be bent or contoured. Bending of components other than rods and crosslinks may lead to premature material fatigue of the implant. If bending or contouring of components other than rods or crosslinks occurs, those components must be discarded. Scratched or notched components, bent components (other than rods or crosslinks), and components that have received a reverse bend must not be used and should be returned to Pioneer Surgical Technology for evaluation.

    Avoid creating a sharp bend or reversing a contour in the rod, as this may lead to premature material fatigue of the implant. Do not bend the rod in the reverse direction, as this may introduce micro fractures that compromise its strength. If reverse rod bending or excessive bending has occurred, the bent rod must be discarded. Please contact RTI Surgical at (888) 778-8771 with any questions in regard to contouring rod prior to surgery.

    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 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.

    Surgical implants must never be reused. An explanted metal implant should never be re-implanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage.

    Do not reuse instruments that are labeled for single use only. Reuse may adversely affect performance and may compromise patient and/or operator safety.

    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 product to Pioneer Surgical Technology.

    Correct handling of the implant is extremely important. Contouring of the metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease fatigue life and may cause fracture.

    Removal of the implant after healing. Metallic implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after healing, particularly in young, active patients. The surgeon should carefully weigh the risk versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risk involved with a second surgery.

    Adequately instruct the patient about the risks and benefits of the surgery and the device prior to and after the surgery. Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in bending or fracture of the device. The product is neither designed or intended to withstand such use. The patient should understand that a metallic implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing (non-union). An active, debilitated, or demented patient who cannot properly use weight supporting devices or follow instructions may be particularly at risk of bending or fracture during postoperative rehabilitation.

    It is extremely important that the physician provides clear directions and warnings and obtains the utmost compliance from the patient postoperatively:

    • Partial- or non-weight bearing may be recommended or required to achieve firm bone union.
    • Warn patient against sudden changes in position, strenuous activity, falls, smoking, consuming alcohol or other drugs not prescribed by the physician, steroids, non-steroidal anti-inflammatory agents, aspirin, and mechanical vibrations or shocks that may loosen the devices.
    • If appropriate, restrict patient’s mobility to allow bony union.
    • Device presence may cause pain, discomfort, abnormal sensations, and increased risk of infection. Instruct the patient to seek medical attention if sudden changes in appearance at the surgical site are noticed or if an unexplained increase in pain is experienced.

    The patient must be made aware of the limitations of the implant prior to agreeing to surgery. Internal fixation devices are temporary devices that cannot support the patient’s weight or movement beyond the time typically necessary for bone healing or fusion. Physical activity and full weight bearing have been implicated in bending or fracture. The patient should understand that an implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing, including falls or other high energy events such as auto accidents. If partial weight-bearing is recommended or required prior to firm bony union, the patient must be advised that bending, loosening and/or breakage of the device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity. Provide the patient with load bearing restrictions. The patient should be advised to inquire if any questions exist regarding the appropriate activities or environments during the healing process.

    Contraindications

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

    Mental or physical impairment which compromises or prevents a patient’s ability to comply with necessary limitations or precautions may place that patient at a particular risk during postoperative rehabilitation.

    Factors such as the patient’s weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the stresses to which the implant is subjected.

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