Products & Implants

Products & Implants


coflex-F® Minimally Invasive Lumbar Fusion

coflex-F<sup>®</sup> Minimally Invasive Lumbar Fusion

The coflex-F® Minimally Invasive Lumbar Fusion System* is a minimally invasive method for posterior fixation of the lumbar spine as an adjunct to fusion. The system is designed to allow for a low-profile, tissue-friendly, anatomical fit. The implant wings can be precisely adjusted to each individual’s anatomy.

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. Please note that this presentation is not valid for Germany. If you seek information on grafts and implants available in Germany, please visit the Germany section on this website.

coflex-F<sup>®</sup> Minimally Invasive Lumbar Fusion


  • Design Features

    • Interlaminar positioning
    • Secure anchorage through rivet fixation
    • Large contact area for optimized stress distribution
    • Five anatomical sizes
    • Color-coded instrumentation
    • Titanium alloy that is biocompatible

    Reduced Iatrogenic Trauma

    • Less muscle trauma and blood loss
    • Smaller skin incision

    Reduced Surgical Risks

    • Excellent safety profile
    • Protection of neural structures

    Reduced Cost

    • Shorter operating time
    • Faster patient rehabilitation

    Ease of Use

    • Simple surgical technique
    • Intuitive instrumentation
  • Indications

    It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in the following conditions: degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

    Contraindications

    Do not use the coflex-F® implant in cases of:

    • Segmental stabilization and fusion without interbody fusion
    • Use in more than one level
    • Any medical or surgical condition precluding the potential benefit of spinal surgery
    • Spondylolisthesis greater than grade 1 or unstable spondylolisthesis
    • Moderate to severe degenerative lumbar scoliosis (Cobb angle of greater than 25°)
    • Previous history of osteopenia, osteoporosis, or osteomalacia
    • Prior decompressive laminectomy, hemilaminectomy or significant lamina fenestration at the index lumbar level(s) which weakens the spinous process
    • Radiographically compromised vertebral bodies at the index lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture)
    • Acute or chronic systemic, spinal or localized infections
    • Obesity
    • Pregnancy
    • Dependency on pharmaceutical drugs, drug abuse, or alcoholism
    • Unwilling or unable to follow postoperative care instructions
    • Previous history of allergy to any component of the coflex-F® device
    • Previous history of severe allergy or anaphylaxis
    • Previous history of disease of bone metabolism
    • Previous history of malignancy

    Safety Precautions

    Prior to use, thoroughly read these instructions for use and become familiar with the surgical technique for implantation of the coflex-F® implant and for the interbody fusion.

    • Keep the instructions for use accessible to all staff.
    • The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques. Proper surgical performance of the implantation is the responsibility of the operating surgeon.
    • The operating surgeon must be capable of performing alternate fusion methods (e.g., pedicle screw fixation) / surgical approaches.
    • The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incorrect operating techniques, the limitations of treatment methods or inadequate asepsis.
    • Under no circumstances may modular implant components from different suppliers be combined.
    • Each patient's record shall document the implant used (name, article number, lot number).
    • During the postoperative phase, in addition to mobility and muscle training, it is of particular importance that the physician keeps the patient well informed about post-surgical behavioral requirements.
    • Damage to the weight-bearing structures can give rise to loosening, dislocation and migration, as well as other complications. To ensure the earliest possible detection of such catalysts of implant dysfunction, the implant must be checked periodically post operative using appropriate techniques.
    • Fracture of the coflex-F® implant wing may occur during preparation when the wings are bent open or during insertion when the wings are crimped.
    • Never reuse an implant. Although the implant may appear undamaged, previous stresses may have created non-visible damage that could result in implant failure.
    • Never use implants if the packaging is damaged. An implant with damaged packaging might be damaged itself and thus may not be resterilized/used.
    • Never use implants that are past their expiration date without resterilizing.
    • Do not resterilize implants if they have been contaminated by blood or secretions.
    • If the device is resterilized, make sure the product is only packaged and sterilized by qualified or trained staff. Follow the general guidelines and aseptic principles when handling items to be sterilized or sterile items. Devices manufactured from different metals should be processed separately to avoid electrolytic action between the metals. The health care provider must validate that the steam sterilization cycle is effective in their facility since all steam sterilization chambers are unique.