Products & Implants

Products & Implants


Contact® ALP System

Contact<sup>®</sup> ALP System Plates

The Contact® Anterior Lumbar Plate (ALP) System provides anterior fixation of the lumbosacral spine (L1-S1) with a focus on efficiency and flexibility. The system uses an expansion screw head locking mechanism that allows the plate to be lagged to the vertebral body while maintaining controlled screw angulation and back out protection.

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.

Contact<sup>®</sup> ALP System Plates


  • Screws

    • Standard and rescue screws available in multiple lengths
    • One step locking mechanism provides back-out protection and controlled screw toggle
    • Self tapping
    • Composed of Ti-6Al-4V

    Plates

    • Lumbar and sacral plates available in multiple lengths
    • Allow for various screw insertion angles
    • Composed of Ti-6Al-4V
  • Implants and instruments are supplied nonsterile. For sterilization instructions, please reference the package insert.

  • Indications

    The Contact® ALP (Anterior Lumbar Plate) System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. Contact® ALP is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis and failed previous spine surgery.

    Warnings

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

    Precautions

    Only experienced spinal surgeons should perform the implantation of anterior lumbar 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 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.

    The components of this device are manufactured from titanium alloy. Mixing of implant components with different materials is not recommended, for metallurgical, mechanical and functional reasons. 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 plates, rods, hooks, wires, etc. which come into contact with other metal objects, must be made from like or compatible metals. Plates and screws of this system should not be interchanged with components of any other system or manufacturer.

    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.

    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.

    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

    Contraindications

    Use of the Contact® ALP System is contraindicated when:

    1. 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 implanted materials.
    2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant.
    3. Metastatic tumors are present in the adjacent vertebral bodies.
    4. Conditions that may place excessive stresses on bone and implants, such that severe obesity or degenerative disease are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician, taking into account the risks verses the benefits to the patient.

    Use of these implants is relatively contraindicated in patients whose activity, mental capability, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure.

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