FDA Clears Bone Putty Delivery System

Yael Waknine

October 07, 2010

October 7, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a bone putty delivery system (NovaBone Putty MIS; NovaBone Products) for use in minimally invasive orthopaedic operations of the extremities, pelvis, and posterolateral spine.

The system was developed for surgeons who require controlled and precise delivery of bone putty to the surgical site and consists of a syringe preloaded with ready-to-use bone graft substitute and 6-mm-diameter cannulas of varying lengths. The putty can be packed into any size or shape void and features a binder that resists migration during irrigation, allowing the bioactive component to stay as placed.

"The launch of the MIS Delivery System will be just the beginning of products our company will be offering to spine surgeons, neurosurgeons and orthopedic surgeons," said Art Wotiz, president of NovaBone Products, in a company news release. "As a growing medical device company, we will introduce a number of new products this year and through 2011 that are based on advancements in bioengineered medical technology."

The bone graft substitute previously was packaged in 2.5-, 5-, and 10-mL sterile thermoformed packs, as well as 1- 2.5-, 5-, and 10-mL syringes.

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