Products & Implants

Products & Implants


PAC Plate® Anterior Cervical Plate System

PAC Plate<sup>®</sup> Anterior Cervical Plate System

The PAC Plate® Anterior Cervical Plate System is a simple, yet versatile 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, hybrid and dynamic constructs, all with a single set. It offers one through four-level plates with a "zero-step" locking mechanism. The locking mechanism is a Nitinol spring that has shape-retaining memory, allowing the screw to pass easily without the need for an additional step to engage the locking mechanism. The industry-leading drive mechanism design helps ensure the screw is rigid and on-axis during insertion.

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.

PAC Plate<sup>®</sup> Anterior Cervical Plate System


  • Plate

    • Standard and dynamic options
    • Accommodates rigid, semi-rigid, hybrid and dynamic constructs
    • Ti-6Al-4V

    Locking Mechanism

    • Zero-step, zero-profile locking mechanism
    • Nitinol spring technology
      • Shape-retaining memory metal that provides a strong, secure locking mechanism between the screw/plate interface
    • NiTi

    Screws

    • Self-drilling and self-tapping design available in fixed and variable options
    • Threaded drive mechanism ensures secure driver attachment
    • Ti-6Al-4V
  • Devices are supplied nonsterile. For sterilization instructions, please reference the package insert. 

  • Indications

    The PAC Plate® System is intended for anterior cervical fixation 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.

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