Choosing the Right Tool for Bone Graft Surgery
29 Apr 2019
The U.S. medical device market is the largest in the world. The U.S. market is valued at approximately $140 billion and is serviced by a medical device industry of about 5,800 companies with over 350,000 employees. One segment of this important industry is dedicated to bone grafting technology. Bone grafting is used in a variety of procedures, including spinal fusion, bone repair, joint replacement, and dental implant. Typically, an incision is made to access the site where the bone graft is to be positioned, the bone graft delivery device is positioned through the incision, and the bone graft delivery device delivers the bone graft through the incision to the bone graft site. Typical bone graft material includes allograft (bone material from a donor, typically a cadaver), autograft (bone material from the patient), or synthetic material. Traditional devices for bone graft surgery include the bone funnel, the syringe, and the cannula. This article examines the key differences among the traditional devices for bone graft delivery and identifies some advances in bone grafting technology over a traditional bone graft delivery system.
A bone funnel is simply a device shaped like a funnel with a flared end connected to a cylinder. Bone graft material is loaded through the flare funnel and pushed through the cylinder with a plunger. The advantage of the bone funnel is that it is relatively simple to operate. The disadvantages of the bone funnel are that it is typically reusable, which means it must be sterilized, and that it cannot be loaded with bone graft material before being positioned or utilize tubes pre-loaded with bone graft material.
A syringe is used in bone graft surgery in the typical manner. The syringe is loaded with bone graft material and delivers the bone graft material to the bone graft site under pressure. The advantage of the syringe is that it typically comes in a single-use, disposable package that is pre-loaded with bone graft material. The syringe does not need to be sterilized before use and can be thrown away after use. The disadvantage is that it may be difficult to position the syringe to deliver bone graft material to the bone graft site, which is why the syringe is often used with the next device, the cannula.
A cannula is used in bone graft surgery with a syringe. The syringe is prepared as described above and connected to a cannula. Again, the cannula is typically a single-use, disposable device. The cannula is positioned through the incision to the bone graft site. The syringe pushes the bone graft material through the syringe and the cannula to the bone graft site.
The Future of Bone Graft Surgery
New technologies, such as the patented Graftgun® device, use a trigger to deliver a controlled amount of bone graft material under controlled pressure. Bone graft material can be pre-loaded into tubes which are then attached to the Graftgun® device.
Technology has evolved from the bone funnel to the patented Graftgun® device. This has made the preparation of bone graft delivery equipment easier and has made use of the bone graft delivery equipment more accurate.
The GraftGun®: The Right Choice For Bone Graft Surgery
29 Apr 2019
Of the 38,600 surgeons working the United States today (according to the U.S. Bureau of Labor Statistics), there is an estimated 25,500 that are orthopedic surgeons (according to the American Academy of Orthopaedic Surgery). That is 66% of the total number of surgeons practicing in the United States. With such a figure in mind, it follows that there would be many products on the market for orthopedic surgeons. For a procedure as common as bone graft surgery, for example, finding the right devices for graft delivery can be challenging.
The GraftGun®, an innovative Graft Delivery System® by SurGenTec, is a viable bone graft delivery system well-suited to the needs of the orthopedic surgeon. This universal graft gun is designed for accuracy and precision, utilizing a patented technology that provides an adequate amount of pressure needed to fill any void during a bone graft delivery. Its tactile feel allows the surgeon to be able to determine when the bone void has been filled with orthobiologic, preventing the bone graft surgery from resulting in nonunion.
The GraftGun’s® loading system allows the surgeon to choose the type of orthobiologic best suited to the operation, whether it is Allograft, Autograft or Synthetic. In addition, the GraftGun® delivers .25cc of viable bone matrix and cortical fibers per squeeze, guaranteeing an accurate injection. The GraftGun® comes equipped with 5cc and 7.5cc tubes, allowing the surgeon flexibility and the ability to deliver orthobiologic to even the most hard-to-reach places. There is also a radiopaque ring included that allows for a clear visual when under fluoroscopy. In addition, the GraftGun® is equipped to post-fill interbody cages, especially those that are expandable and therefore difficult to fill prior to insertion.
The GraftGun® is single-use, saving the surgeon the costs of sterilization, and it is single-handed, allowing ease of operation during the bone graft surgery. It is less invasive than other bone graft delivery systems, allowing for greater accuracy, safety, and efficiency.
The GraftGun® is the ideal universal bone graft delivery system for the modern orthopedic surgeon. The precision, accuracy, and flexibility that the GraftGun® provides makes it unlike any bone graft delivery system on the market.
Understanding Medical Devices: 4 Commonly Asked Questions
10 Apr 2019
The U.S. medical device industry employs more than 365,000 people across 5,800 companies. Medical devices are instruments and machines that are intended for use in the diagnosis of a disease, as well as the cure, mitigation, and treatment, of a disease. Similarly, instruments like bone graft delivery devices are intended to affect the structure or any particular function of the body.
Here are some commonly asked questions pertaining to the medical device industry and how they are registered:
How are these devices classified?
The Food and Drug Administration (FDA) places all medical devices into one of three regulatory classes: Class I devices are subject only to general controls, Class II devices are those for which general controls alone are insufficient to provide a reasonable assurance of safety and effectiveness, and Class III devices are those for which insufficient information exists to determine that general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness.
How does a device become registered?
- All proprietary names must be reported when the device is first listed and during annual registration updates.
- All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution.
- A device must be listed by not only the manufacturer, but the specification developer, single-use device reprocesser, and remanufacturer, as well.
What are some examples of medical devices?
Examples of these important tools include surgical lasers, orthopedic pins, sutures, pacemakers, wheelchairs, and bone graft delivery devices. Diagnostic products can also be considered to be medical devices, including pregnancy test kits and magnetic resonance imaging (MRI) systems.
Is the Medical Device Excise Tax part of the Annual Registration User Fee?
Since it is not related to any changes to registration and listing requirements, and isn’t enforced, collected, or implemented by the FDA, the Medical Device Excise Tax is not part of the Annual Registration User Fee.
If you want to learn more about the importance of medical devices, bone grafting, or work with a legitimate and experienced company that sells quality bone graft delivery devices, give SurGenTec a call right away.
Factors to Examine When Considering a Bone Graft Procedure
03 Apr 2019
Approximately 6.8 million Americans use devices to assist with their mobility. The U.S. medical device market accounts for 40% of the global market and the Department of Commerce estimates that the U.S. exports $44 billion in medical devices annually. Of these devices, many involve the use of bone grafting technology. Bone grafting is a surgical procedure that replaces missing bone in order to repair complex bone fractures that pose a health risk to the patient or fail to heal properly.
The needs for bone grafts can be caused by various injuries, including bone fractures. On average, bone fractures heal in two to ten weeks. The four most common reasons people receive bone grafts are multiple fractures that fail to heal properly, fusion to help two bones heal across a damaged joint, bone regeneration following disease or injury, and for healing bones following implantation of medical devices such as joint replacements.
A 16-year study of two million bone graft patients discovered that 83% of bone grafts involve autogenous bone grafts harvested from the patient; 17% involved artificial bone graft substitutes. A 16-year study of two million bone graft patients found doctors and patients in the United States are moving from traditional bone graft devices to bone graft substitutes.
On the leading edge of bone grafting technology is SurGenTec’s GraftGun® Graft Delivery System (GDS®), which is designed to provide universal, quick, and accurate bone graft delivery to a surgical site without the issues associated with a traditional funnel. Its patented, controlled release bone grafting technology safely dispenses bone graft with sufficient pressure to easily fill any bone void during bone graft surgery. The Graftgun® Graft Delivery System® includes SurGenTec’s loading device, a technology which gives surgeons the freedom to choose the bone graft that best suits their needs.
This medical technology can help provide the best possible results for bone graft procedures. By using our patented GraftGun®, instead of the traditional funnel, bone grafting can become less invasive and more accurate. SurGenTec’s Bone Graft Delivery Devices® are developed with both surgeon and patient in mind.
SurGenTec also recently announced the successful completion of the clinical launch of its new GraftGun® bone graft delivery system combined with ViBone Viable Bone Matrix prefilled tubes.