Products & Implants

Products & Implants


SlimFuse® Anterior Cervical Plate System

SlimFuse<sup>®</sup> Anterior Cervical Plate System Plates

The SlimFuse® System is an innovative, single-hole-per-level anterior cervical plate system designed to meet the varying clinical needs of surgeons performing anterior cervical discectomy and fusion (ACDF) procedures. The system is able to accommodate rigid, semi-rigid and translationally dynamic options, all with a single set. It offers one through four-level plates with a single-step, integrated expansion head locking mechanism. This single screw per level design with the screw hole located in the center provides the potential for reduced surgical time.

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.

SlimFuse<sup>®</sup> Anterior Cervical Plate System Plates


  • Plate

    • Standard and dynamic options
    • Integrated pivot base allows for rigid, semi-rigid and dynamic constructs
    • Ti-6Al-4V

    Locking Mechanism

    • Integrated expansion head locking mechanism
    • Ti-6Al-4V

    Screws

    • Self-drilling and self-tapping designs
    • Intermediate rescue option with the Split-Tip Screw
    • Stab-n-grab drive
    • Ti-6Al-4V
  • This system is supplied nonsterile. For sterilization instructions, please reference the package insert.

  • Indications

    The SlimFuse Anterior Cervical Plate System is intended for anterior cervical fixation as an adjunct to cervical fusion for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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.

    Warnings

    This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

    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

    Only experienced spinal surgeons should perform the implantation of anterior cervical spinal systems with specific training in the use of this spinal system. 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 cervical screw diameter and length. While proper selection can help minimize risks, the size, shape, bone quality, stock, and differentiation of anatomical structures 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. 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.

    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, accelerates 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 plates, 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.

    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 failure.

    Contraindications

    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.

    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.