Biomet Spine & Bone Healing Technologies

Device Configuration


The SpF® Stimulator is an implantable device consisting of two titanium cathodes connected to a generator through dual silicone insulated lead wires.

Generator
The generator case, which includes the power source and the electronics to deliver the therapeutic Direct Current (DC) stimulation, is fabricated from medical grade titanium. A circular area on the generator is plated with a 5 ± 1 µm thick area of platinum, which functions as the anode. The electronics housed in the solid-state constant current generator are powered by one lithium manganese dioxide battery that produces a constant current output for approximately 6 months. The electronics and battery are hermetically sealed within the generator to prevent leakage.

Lead Wires
The lead wires consist of a silicone insulated brazed strand of stainless steel wire. These insulated leads are attached to the generator and the cathodes by titanium connectors that can be disconnected at either site. The insulated leads are 15 cm in length.

Output Signal
The SpF® Stimulator is available with either a 40 µA or a 60 µA direct current output signal.

Cathode Configurations
In addition, there are two cathode configurations for the SpF® Stimulator: the mesh and the preformed wave. The mesh configured cathode is made from two strands of 0.01 inch diameter titanium wire formed into alternating loops and twists. The preformed wave is made from three strands of 0.01 inch diameter titanium wire. The length of the cathode may be altered based on clinical need. Furthermore, the choice of cathode configuration is dictated by the specific fusion application and surgeon preference.


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