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Zimmer, Inc.

UniLInk™ and UniLink™ 5/1 Interspinous Fusion System

The UniLink System: Secure Fixation with Low Profile

Product Description

Utilizing a shorter plate height with an elliptical insert allows the UniLink Device to seed its spikes 4-6mm more anterior without compromising the structural rigidity of the plate. This innovative design also reduces the plate’s high/low points, keeping it more linear to the insert.

UniLink System

The UniLink Interspinous Fusion System delivers maximum procedural flexibility through a minimally invasive approach. The UniLink System offers an array of customizable, low-profile implants to accommodate anatomical variation and surgical technique preferences.

 UniLink 5/1 System

The UniLink 5/1 Interspinous Fusion System incorporates a modified design to facilitate L5-S1 capture or to accommodate non-linear anatomy. The UniLink 5/1 provides the same low-profile fixation and utilizes the same instrumentation as the UniLink System.

Features

  • Modular Customization: accommodates anatomical variation, insert material selection and surgical technique preferences, and allows assembly on the back table or in-situ.

  • Spikes: Device’s spikes have a conical profile that is designed to maximize bony purchase and are engineered to increase stability over similar devices.

  • Optional Inserts: PEEK-OPTIMA® Polymer or Titanium Alloy options which are available in 8-18mm sizes in 2mm increments. The elliptical design matches anatomy to promote graft loading, windowed design to accommodate graft material packing and the Bulleted shape helps to distract and indirectly decompress.

  • Cross Bar Plate: available in 28, 32, 36, 40, and 55mm sizes. The Proprietary ramped cross bar allows provisional tightening which prevents separation and minimizes surgical fiddle factor.

  • Locking Plate: available in 28, 32, 36, 40, and 55mm sizes. Star drive set screw designed to minimize stripping while providing secure locking and Accommodates 9° angled variation (“wag”) and allows independent compression for optimal fit.

  • UniLink Graft: The UniLink Graft is a structural cortical allograft, available in multiple sizes for use with the UniLink or UniLink 5/1 Systems. 8-20mm sizes in 2mm increments and Allograft shaped to fit between interspinous processes with a low profile design to allow anterior graft placement while minimizing construct height.

ZS-SA0700-43_A

Device Description

The UniLink Interspinous Fusion System of Zimmer Spine is an internal fixation device for spinal surgery. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patients.  The device may consist of titanium alloy (per ASTM F136), or both titanium alloy and polyetheretherketone (PEEK) (per ASTM F2026).  All implants are intended for single use only and should not be reused under any circumstances.

Indications

The UniLink Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive).  It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The UniLink Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.

Contraindications

Contraindications for the UniLink Interspinous Fusion System are similar to those of other systems of similar design, and include, but are not limited to:

  1. Patients with probable intolerance to the materials used in the manufacture of this device.
  2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome.
  3. Patients resistant to following post-operative restrictions on movement, especially in athletic and occupational activities.
  4. Use with components from other systems.
  5. Grossly distorted anatomy caused by congenital abnormalities.
  6. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
  7. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation.
  8. Any case where the implant components selected for use would be too large or too small to achieve a successful result.
  9. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
  10. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
  11. Any case not described in the indications for use.
  12. Incompetent or missing posterior arch (e.g., laminectomy, pars defect, severe osteoporosis).
  13. Reuse or multiple uses.
  14. Prior fusion at the level to be treated.

See also the WARNINGS, PRECAUTIONS and POSSIBLE ADVERSE EFFECTS section.

WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS

Warnings and Precautions

The implantation of spinal implant systems should be performed only by experienced spinal surgeons with specific training in the use of the spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.  

Knowledge of surgical techniques, proper reduction, selection and placement of implants, and pre- and post-operative patient management are considerations essential to a successful surgical outcome.  Appropriate selection, placement and fixation of the spinal system components are critical factors which affect implant service life.  As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanics and other extrinsic factors, which limit their service life. Accordingly, strict adherence to the indications, contraindications, precautions, and warnings for this product is essential to potentially maximize service life.  (Note: While proper implant selection can minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of the implants).

Patients who smoke have been shown to have an increased incidence of pseudoarthrosis. Such patients should be advised of this fact and warned of the potential consequences. Patients with previous spinal surgery at the level to be treated may have different clinical outcomes compared to those without a previous surgery. Based on the fatigue testing results, the physician/surgeon should consider the level of implantation, patient weight, patient activity level, and other patient conditions, etc. which may have an impact on the performance of the system.

If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g. substantial walking, running, lifting, or muscle strain) resultant forces can cause failure of the device. In some cases, progression of degenerative disease may be so advanced at the time of implantation that the expected useful life of the appliance may be substantially decreased. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.  Patients should be instructed in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly. The patient should understand that a metallic implant is not as strong as normal, healthy bone and will bend, loosen or fracture if excessive demands are placed on it.  An active, debilitated, or demented patient who cannot properly use weight supporting devices may be particularly at risk during postoperative rehabilitation.

Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects.  Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.

As with all orthopedic and neurosurgical implants, none of the UniLink Interspinous Fusion System components should ever be reused under any circumstances. Risks associated with reuse include infection, non-union (pseudarthrosis), serious patient injury or death.

Due to the presence of implants, interference with roentgenographic, CT and/or MR imaging may result.  The UniLink Interspinous Fusion System has not been evaluated for safety and compatibility in the MR environment.  The UniLink Interspinous Fusion System has not been tested for heating or migration in the MR environment.  It must be noted that there are several different manufacturers and generations of MRI systems available, and Zimmer Spine cannot make any claims regarding the safety of Zimmer Spine implants and devices with any specific MR system.

Physician Note: The physician is the learned intermediary between the company and the patient. The indications, contraindications, warnings, and precautions given in this document must be conveyed to the patient.  If requested, additional information, including surgical technique manuals, may be obtained through corporate sales representatives.

Possible Adverse Effects

Potential complications and adverse effects for this system are similar to those of other spinal instrumentation systems, and include, but are not limited to:

  1. Early or late loosening of any or all of the components.
  2. Disassembly, bending, and/or breakage of any or all of the components.
  3. Foreign body (allergic) reaction to implants.
  4. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
  5. Infection.
  6. Dural tears, persistent CSF leakage, meningitis.
  7. Loss of neurological function including paralysis (partial or complete), radiculopathy, and/or the development or continuation of pain, numbness, spasms, or sensory loss.
  8. Cauda equina syndrome, neurological deficits, paraplegia, reflex deficits, irritation, and/or muscle loss.
  9. Loss of bladder control or other types of urological system compromise.
  10. Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
  11. Fracture, micro-fracture, resorption, damage, or penetration of any spinal bone.
  12. Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
  13. Non-union (pseudarthrosis), delayed union, mal-union.
  14. Cessation of any potential growth of the operated portion of the spine.
  15. Loss of or increase in spinal mobility or function.
  16. Inability to perform the activities of daily living.