Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System

Clinically Effective

  • Heal rates as high as 83.3%1
  • 60% improvement over placebo in a double-blind, randomized study2
  • More than 30 years of clinical use1
  • 75% of Biomet customers are repeat prescribers3

Scientifically Proven

  • Pre-clinical research has shown that capacitive coupling stimulation induces significantly higher levels of cellular proliferation than other electrical stimulation technologies4
  • In vitro pre-clinical research has shown upregulation of multiple bone morphogenetic proteins (BMPs) in as little as 30 minutes of exposure with optimal upregulation at 24 hours of exposure5

Cost-Effective

  • According to a published, peer-reviewed study, electrical stimulation was shown to be a cost-effective treatment for fracture nonunions6,***

Patient Compliance

  • Smallest and lightest bone growth stimulation device on the market, designed with active patients in mind7
  • Compliance monitoring

INDICATIONS:
The Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System (P850022/S017) 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.

USAGE:
All Biomet® 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. 

CONTRAINDICATIONS:
The use of these device systems is contraindicated if the individual has synovial pseudarthrosis. 

For complete prescribing information including success rates, warnings, and precautions, please review the Complete Manual and Package Insert or call 1.800.526.2579.

 

  1. Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System (P850022/S017).
  2. Scott, G. and King, J.B. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bones. J Bone Joint Surg Am, 1994. 76(6):820-6.* 
  3. Data on file at Zimmer Biomet, EBI, LLC
  4. Wang, Z., Clark, C.C. and Brighton, C.T. Up-Regulation of Bone Morphogenetic Proteins in Cultured Murine Bone Cells with Use of Specific Electric Fields. J Bone Joint Surg Am, 2006. 88:1053-1065. *, **
  5. Brighton, C.T., Wang, W., Seldes, R., Zhang, G. and Pollack, S.R. Signal transduction in electrically stimulated bone cells. J Bone Joint Surg Am, 2001. 83A(10):1514-23.*,**
  6. Wu, N., Lee, Y., Segina, D., Murray, H., Wilcox, T., Boulanger, L. Economic burden of illness among US patients experiencing fracture nonunion. Orthop Res and Reviews, 2013. 5:21-33.*
  7. Data on file at Zimmer Biomet, EBI, LLC, P&R17001

 

*FINANCIAL DISCLAIMER: In support of their research for or preparation of this work, one or more of the authors may have received financial remuneration from Zimmer Biomet, EBI, LLC or Biolectron, Inc.

**PRE-CLINICAL DISCLAIMER: Following non-invasive electrical stimulation, increases in cell proliferation and multiple growth factors have been observed in various pre-clinical in vitro cellular and in vivo animal studies. Although not indicative of human clinical results, these factors have been implicated in various models of bone repair.

*** This study measured actual health care resource utilization and did not assess clinical effectiveness or healing times.

Legal Manufacturer:

Zimmer Biomet, EBI, LLC 
399 Jefferson Road
Parsippany, NJ 07054  USA


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This material is intended for health care professionals.  Distribution to any other recipient is prohibited.
For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.