Commonly Asked Questions

Q.   Can the Bone Shark be re-sterilized in an autoclave?

 A.     No. The Bone Shark is a single-use device and will not withstand the heat of an autoclave.

Q.   What kind of surgery is the Bone Shark best suited for?

 A.    The Bone Shark can be used during any surgery that requires bone graft material.  The ideal cases are those which utilize local patient bone such as single and double level lumbar and cervical fusions and minimally invasive procedures.  The Bone Shark is also being used in facial, dental and small bone reconstructive surgeries. We do not recommend using the Bone Shark on long segmental fusions.

Q.   Can the collection chamber be used to mix the bone graft with osteobiologics? 

A.    Yes.    

Q.   What size material will the bone output be and how much bone will be lost in the process? 

A.    The Bone Shark creates bone material between 2 to 3 mm in length.  Almost 100% of the bone that is being milled will enter into the collection chamber.

Q.   Is the Bone Shark FDA approved?

 A.    The Bone Shark is a Class I Medical Device and does not require specific FDA approval.  However, all materials used in the device have been FDA Approved.

Q.   Can a hospital bill an insurance carrier for the use of the Bone Shark?

 A.    Reimbursable expenses differ by insurance carrier and there is no guarantee that the hospital will be entitled to reimbursement.  We encourage hospitals to submit for reimbursement under National Billing Code A4649. 

Q.   Are there any tricks associated with using the Bone Shark?

 A.  We have made the use of the Bone Shark as simple as possible.  We encourage the user to review our brief training video and instructions included on this web site.

Q.   Is there a reason why the Bone Shark has two plungers?

A.  On rare occasions, the plunger will drop off the sterile table.   We include a second plunger just in case that should happen. 

Q.   Does Medical Innovators have distributors that we can order from?

A.  Medical Innovators works with distributors located throughout the United States and is always adding more.  If you have a distributor that does not carry the Bone Shark, please have them contact us at 888-422-7717 to get started with this product.  The Bone Shark is also available for purchase directly from Medical Innovators.