Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System

Clinically Effective

  • Highest overall success rate for lumbar spinal fusions - 84.7%1
  • Clinical data supporting device use in patients undergoing posterolateral fusion, anterior lumbar interbody fusion (ALIF) or posterior lumbar interbody fusion (PLIF)1
  • 270,000 patients treated to date2
  • 75% of Biomet customers are repeat prescribers2

Scientifically Proven

  • Pre-clinical research has shown that capacitive coupling stimulation induces significantly higher levels of cellular proliferation than other electrical stimulation technologies3
  • 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 exposure4

NASS Coverage Recommendations Support Capacitive Coupling Stimulation

In its new coverage recommendations, NASS (North American Spine Society) recommends capacitive coupling stimulation for high-risk patients undergoing posterolateral lumbar spinal fusions.

Patient Compliance

  • Smallest and lightest bone growth stimulation device on the market, designed with active patients in mind5
  • Compliance monitoring

INDICATIONS:
The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System is a non-invasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels (P850022/S017). 

USAGE:
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:

There are no known contraindications regarding the use of the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System.

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. Goodwin, C.B., Brighton, C.T., Guyer, R.D., Johnson, J.R., Light, K.I. and Yuan, H.A. A Double-Blind Study of Capacitively Coupled Electrical Stimulation as an Adjunct to Lumbar Spinal Fusions. Spine, 1999. 24(13):1349-1356.*
  2. Data on file at Zimmer Biomet, EBI, LLC
  3. 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.*, **
  4. 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.*, **
  5. Data on file at Zimmer Biomet, EBI, LLC, P&R17341A 

*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.

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.