Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System

Effective

  • The only electrical stimulation device on the market that is FDA approved for 24-hour use1

Scientifically Proven

  • In one in vitro pre-clinical study, upregulation of multiple bone morphogenetic proteins (BMPs) was shown to occur with capacitive coupling (CC) stimulation in as little as 30 minutes of exposure with optimal upregulation occurring at 24 hours 2,*

An Established Product

  • Over 85,000 OrthoPak Stimulator Systems devices sold3
  • More than 30 years of proven clinical use1

Designed with Patients in Mind

  • Smallest and lightest bone growth stimulation device on the market, designed with active patients in mind4
    • The lightweight feature of the OrthoPak stimulator means less weight being placed on the fracture nonunion treatment site
  • Compliance monitoring software – The OrthoPak stimulator contains embedded software that displays patient treatment data. This data may be downloaded to a health care professional’s computer for reviewing, storage or printout, via the use of the Patient Compliance Data Download Software5

Indications

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.

Usage

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.

Contraindications

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 extension 6000.

Financial Disclaimer

In support of their research for or preparation of this work, one or more of the authors may have received remuneration from Zimmer Biomet.

Guides and Manuals

References

  1. Data on file Zimmer Biomet -P850022
  2. Wang Z, Clark CC, Brighton CT. Up-regulation of bone morphogenetic proteins in cultured murine bone cells with use of specific electric fields. J Bone Joint Surg Am. 2006;88(5):1053-1065.
  3. Data on file at Zimmer Biomet - ZBDATA1_20
  4. Data on file at Zimmer Biomet, EBI, LLC, P&R17001
  5. Compliance Data Download Software User Manual – PN 1067778-01

 

*Although not indicative of human clinical results, outcomes from pre-clinical research have been implicated in various models of bone repair

Legal Manufacturer:

EBI, LLC d/b/a Zimmer Biomet
Bone Healing Technologies
399 Jefferson Road
Parsippany, NJ 07054  USA

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For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counselling 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.