INDICATIONS: The Biomet® EBI Bone Healing System® is indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system.

CONTRAINDICATIONS: Nonunion fractures in which a synovial pseudarthrosis (fluid filled gap) exists. Under certain conditions, electromagnetic stimulation could inhibit the output of some demand pacemakers or implantable defibrillators. Therefore, it is not recommended for patients with certain types of pacemakers or implantable defibrillators.

Patients should be cautioned to avoid coming in close proximity to pacemaker or defibrillator wearers during stimulation. Use of this device system on pregnant patients has not been evaluated; therefore, it is not recommended in these cases.

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.

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

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

CONTRAINDICATIONS: There are no known contraindications.

INDICATIONS: The SpF® PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in one or two (1 or 2) levels. The SpF®-XL IIb Implantable Spinal Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in three (3) or more levels.

CONTRAINDICATIONS: There are no known contraindications regarding the use of SpF® Implantable Spinal Fusion Stimulators.

INDICATIONS: EBI OsteoGen®- Implantable Bone Growth Stimulators. are constant direct current implantable generators indicated in the treatment of long bone nonunions

CONTRAINDICATIONS: There are no known contraindications: however, due to insuffcient clinical experience; it is not recommended that they be used in the following conditions: pathological fractures due to malignant tumors or in the presence of active osteomyelitis.

Federal Law (U.S.A.) restricts these device to sale by or on the order of a physician. Rx Only - Prescription Only - Single Patient Use Only - Not for Re-Sale or Re-Distribution - Do Not Reuse. Complete prescribing information including full contraindications, warnings and precautions associated with the use of these devices may be found online at

https://www.zimvie.com/en/spine/bone-healing-products.html or by calling 1.800.526.2579.