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Home/Company News/Arthrosurface Toe Motion Preservation System Cleared by FDA
Company News

Arthrosurface Toe Motion Preservation System Cleared by FDA

March 13, 2014 2 min read Premium comments

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Arthrosurface Toe Motion Preservation System Cleared by FDA
Diagram Foot Bones / Source: American Academy of Orthopaedic Surgeons
Secondary

There will be fewer toe fusions as Arthrosurface, Inc., founded in 2002, has received FDA clearance for its ToeMotion Total Toe Restoration System.

The company announcement on March 7, 2014, said the device will be launched at the AAOS (American Academy of Orthopaedic Surgeons) in New Orleans the week of March 10th.

The system consists of a metatarsal-based HemiCAP implant and a new inlay metal baseplate with a poly insert for the phalangeal side of the joint. Both sides of the metatarsal joint, according to the company, will now benefit from the tapered fixation post design which has been successfully used for almost 10 years. “The system provides proven fixation, while the inlay implants preserve bone. Because it is implanted by milling instead of by using saw cuts, the ToeMotion system avoids resecting the intrinsic tissues that provide stability to the toe, ” stated the company press release.

Thomas San Giovanni, M.D., from the University of Miami and the system’s designer, said, “For many years we have been using the metatarsal-based HemiCAP with great success. However, there are patients that require an implant on both sides of the joint, rather than a fusion, so now we can offer a motion preserving option to those patients looking to maintain an active lifestyle. In Florida, our patients are active and outdoors all year long so they are looking for an active alternative to fusion. Never moving their toe again is not a very appealing option to them, so this is why I have been working with Arthrosurface to design a system that would be minimally invasive, stable and allow my patients to maintain their motion.”

Steve Ek, CEO and co-founder of Arthrosurface stated “the extremities market is providing an excellent opportunity for growth over the next several years. As such, we are targeting to launch another five extremity products along with the new ToeMotion system. Our platform technology for rock-solid immediate fixation and inlay arthroplasty has been proven to work on many different joints. But, what is really exciting is how well suited inlay arthroplasty is for the extremity joints. These joints are inherently smaller, very mobile and traditionally have not done very well with larger more invasive implants that require a lot of bone removal. Smaller implants that restore anatomy and take away very little bone is the wave of the future.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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