FDA Clears Thumb Implant for Osteoarthritis

Small Bone Innovations (SBi), a New York, NY, company focused exclusively on small bone and joint orthopedic devices, has received FDA clearance to market a new implant for osteoarthritis at the base of the thumb. The product, Artelon CMC Spacer Arthro, is an extension of SBi’s existing line of carpal metacarpal spacers for base-of-thumb osteoarthritis.

SBI, which prides itself on developing products with guidance from orthopedic surgeons, designed this Artelon spacer to allow minimally invasive, arthroscopic implantation in the joint between the first metacarpal and the trapezium. The idea is that by avoiding violation of the joint capsule, patients will experience longer maintenance of joint stability, faster recovery and less pain.

In a statement issued by SBi, one of the company’s consulting surgeons, Dr. Randall Culp from Thomas Jefferson University in Philadelphia, said, “Arthroscopic implantation of an Artelon spacer is a good option for younger, more active, people who may be reluctant to undergo invasive surgery for a condition that is increasingly common among this group.”

And SBi’s CEO, Anthony Viscogliosi, points out that the device allows patients to undergo therapy earlier in the disease progression, and eliminates or minimizes the sacrifice of healthy tissue in other carpal metacarpal joint procedures that commonly include removal of the trapezium and harvesting tendon from the forearm.

Since being founded in 2005 by Viscogliosi Bros. — the musculoskeletal-focused venture capital firm created SBi by acquiring established companies in the orthopedic field, to create a single source of products for surgeons specializing in small bones and joints or limbs — the company has been on a role. Last year, it received five new FDA 510(k) clearances and completed eight M&A licensing and distribution deals; 19 new products were introduced. In April, SBi secured a $20 million debt facility financed by the Drawbridge Special Opportunities Fund.

For more on SBi and many other emerging orthopedic companies, visit the Orthopedics Floor at OneMedPlace.com and download a PDF special report.

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