PREPARATION AND USE

BEST RESULTS WILL BE OBTAINED BY FOLLOWING THESE DIRECTIONS.


  1. The KG 1 is packaged with plunger inserted in the cannula, ready to be inserted into the prepared, distracted disk space. Inspect the package prior to use.

  1. Remove from the sterile package, inspect and handle the KG 1 components in accordance with aseptic techniques and per orthopedic surgical practice.

  2. Distract the disk space with wedge dilators per the cage manufacturers protocol. Maintain the distraction with provisional contralateral pedicle screw fixation. Attention: A minimum of 8mm of distraction is necessary to safely use the KG 1.

  3. Try a sample of the graft material with the KG 1 to ensure flowability.

  4. Insert the plunger/stylet into the empty cannula without the funnel and insert the complex into the disk space. Remove the stylet and attach the funnel.

  5. Apply the graft material with thumb and finger pressure into the cannula. Use the funnel as a bone graft reservoir. Push the plunger all the way down to expel the graft material. If the disk space does not vent the air out of the disk, remove the KG 1 and increase the size of the annulotomy. Apply 1-2 ml of graft with each pass of the plunger. You will feel resistance of flow when the disk space has filled up. Tapping on the plunger will expel residual graft, avoid using a mallet.

  6. Remove the stylet and funnel and directly observe the area around the annulotomy/cannula interface to confirm that graft material has not overflowed.

  7. Remove the KG 1 and insert cage per the manufacturer recommendations.

  8. Discard the KG 1 with other disposables after single patient use.

  9. Continue with the surgical procedure and instrumentation where indicated.