Products & Implants

Products & Implants


coflex-F+™ Posterior MIS Fusion System

coflex-F+™ Posterior MIS Fusion System

The coflex-F+™ implant is an interlaminar stabilization device that can be delivered through a small skin incision. It provides significant segmental stability and allows for posterior fixation as an adjunct to fusion post decompression.

The implantation technique is safe and easy. Complications encountered with conventional pedicle screw systems can be avoided.

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+™ Posterior MIS Fusion System


  • The coflex-F+™ implant - when less is more!

    MIS Posterior Stabilization Fusion
    • Deep, interlaminar positioning to counteract posterior forces while maintaining foraminal height
    • Large contact surface for optimized load distribution
    • Strong rivet fixation for a perfect fit to the spinous processes
    Posterior fenestration for placement of bone graft and/or bone substitutes in combination with posterolateral fusion

    Reduced Iatrogenic Trauma

    • Less muscle trauma
    • Less blood loss
    • Smaller skin incision

    Reduced Surgical Risks

    • Excellent safety profile of implant
    • Protection of neural structures
    • Reduced radiation exposure for surgeon, OR-staff and patient

    Reduced Cost

    • Shorter operating time
    • Faster patient rehabilitation

    Ease of Use

    • Simple surgical technique
    • Five anatomical sizes
    • Color-coded instrumentation
  • Indications

    It is intended for application at all levels of the lumbar spine (L1–S1) in cases of back pain and discogenic pain due to lumbar degenerative processes of instability as pseudospondylolisthesis (up to Meyerding grade I), osteochondrosis, instability of facet joints and lumbar stenosis or lumbar disc prolapses.

    Contraindications

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

    • 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.
    • 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.