SOLE Medial Column Fusion Plate

The SOLE™ Medial Column Fusion Plate (SOLE MCF) is a plating line designed to address specific needs of foot and ankle deformities and reconstructions, involving small bone joints and osteotomies within the midfoot and hindfoot.

The product line consists of a range of anatomically designed plates, left and right, in a variety of lengths and shapes to address patient needs. The implant range also includes a wide range of locking and non-locking screws and the necessary instrumentation for safe and efficient use of the product.

The SOLE MCF plates and screws will be provided in single, sterile packaging with the dedicated instruments in a re-sterilizable tray.

Features and Benefits

  • Stainless steel manufacturing material
    • The manufacturing material was chosen for improved stiffness of the plate and screw constructs.
  • Variable angle locking for screws
    • The screw locking mechanism is designed to provide flexibility in screw placement in difficult anatomical positions.
  • Anatomical design
    • The plates are designed for left and right in standard and wide versions for optimal implant placement.
  • Wide variety of screw lengths
    • The variety of screw lengths are designed to provide optimal implant selection.
  • Dedicated reduction rail
    • The reduction rail is designed to reduce the specific joints for easier implant insertion.

INTENDED PURPOSE
The SOLE MCF is intended to provide bone fixation.

Indications

The SOLE MCF is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus).

Specific indicated procedures include:
• Arthrodesis
• Joint depression stabilization
• Fracture and/or osteotomy fixation
• Reconstruction
• Revision to be performed for conditions such as Charcot neuroarthropathy.

Contraindications

Do not use SOLE MCF if a surgical candidate exhibits or is predisposed to any of the following contraindications:
• Active osteomyelitis or deep tissue infections at surgical site
• Infected ulcerations at the surgical site
• Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the device
• Inadequate coverage of the surgical site
• Suspected or documented metal allergy or intolerance
• Other medical or surgical conditions that would preclude the potential benefit for surgery
• Any mental or neuromuscular disorder that could create an unacceptable risk of fixation failure or complications in postoperative care as it could result in a treatment failure in the intended population.

Instructions For Use