The Biomet OrthoPak Non-invasive Bone Growth Stimulator System is
indicated for the treatment of an established nonunion acquired
secondary to trauma, excluding vertebrae and all flat bones, where the
width of the nonunion defect is less than one-half the width of the
bone to be treated - P850022/S017. A nonunion is considered to be
established when there are no visibly progressive signs of healing - P790002/S028.
All OrthoPak Bone Growth Stimulator Systems are designed to deliver
270 days of continuous therapeutic treatment for 24 hours per day. The
recommended daily therapeutic treatment is continuous for 24 hours.
Federal Law (U.S.A.) restricts this device to sale by or on the order
of a physician. Rx Only - Prescription Only - Single Patient Use Only
- Do Not Reuse.
The use of these device systems is contraindicated if the individual
has synovial pseudarthrosis.
For complete prescribing information including contraindications,
warnings, and precautions, please refer to the Biomet OrthoPak
Non-invasive Bone Growth System Complete Manual and Package Insert or
the Patient Manual PN1067799-00 or PN1067800-00 or call 1-800-526-2579
In support of their research for or preparation of this work, one or
more of the authors may have received remuneration from Zimmer Biomet.