Strategic orthopaedic-related 510(k)s issued in April 2017

By Julie A. Vetalice

FDA released 49 510(k)s in April. Of these 49, we've zeroed in on nine that are strategic¹ and three to which we'd like to draw greater attention.

Of the strategic nine, five represent the company's first orthopaedic-related 510(k) ever. These are denoted with an asterisk in the list below.

Exactech filing as Blue Ortho: ExactechGPS Total Shoulder Application; Greens Surgicals*: Locking Bone Plates and Screws Osteosynthesis Plating System, DHS/Dynamic Condylar Plate; Innovasis: Ax Standalone ALIF System; Mazor Robotics: Mazor X; NuVasive Specialized Orthopedics: PRECICE UNYTE CoCr System; OsteoNovus*: NovoGro Putty; Pantheon Medical*: Balanced Plating System; Summit Spine*: Yellowstone Lumbar Interbody Fusion System; XpandOrtho*: XO1 Knee Balancing System

Let's take a closer look at three of these: a disruptive trauma product from NuVasive, a bone void filler from OsteoNovus and a soft tissue balancing system for total knee replacement from start-up XpandOrtho.

NuVasive Specialized Orthopedics | PRECICE UNYTE | K162927

I chose this product because NuVasive believes that it could completely cannibalize external fixation. This bone-compressing system is designed to treat complex/poorly-healing fractures with technology acquired from Ellipse Technologies in 2016. Initial launch is underway, as indicated in the company's 1Q17 earnings call; full launch is slated for 2H17.

In the company's 4Q16 call, Gregory Lucier, Chairman and CEO, described UNYTE like this:

"Where PRECICE lengthens the bones in the legs, this actually compresses them and is an alternative to external fixation, which is the normal protocol for hard-to-heal fractures. We're very excited about the product. And we think it ultimately could obsolete the entire external fixation market. ...it's a great example of why we bought [Ellipse Technologies], because it has a chance to completely re-think the orthopedics industry."

OsteoNovus | NovoGro Putty | K162087

NovoGro synthetic bone void filler is claimed to support robust bone growth by six weeks; the company has also developed granule and block formats. This submission was filed February 21, 2017 and cleared on April 18, 2017—just a two-month wait.

The technology is licensed from the University of Toledo, and OsteoNovus has received funding through the Ohio Third Frontier project and Third Frontier partner organizations, as well as private investors. As noted by The Toledo Blade, OsteoNovus is slated to close a partnership with an unnamed $100MM+ revenue company for non-exclusive private label sales of NovoGro; we'll be watchful for that news.

This company hit our radar in 2013 as a newcomer to the NASS floor. In 2014, we interviewed Dr. Vijay Goel, OsteoNovus' co-founder, about his involvement in The Center for Disruptive Musculoskeletal Innovation.

XpandOrtho | XO1 Knee Balancing System | K162237

This start-up was registered in California in 2012 and is helmed by an orthopaedic surgeon as its president. XpandOrtho's sterile-packaged, wireless, disposable X01 device is compatible with nearly all total knee systems from major manufacturers to perform multiplanar balancing of the knee joint. Soft tissues can be released with the device in place, giving real time visual feedback to the surgeon. When the procedure is complete, the device preserves an electronic record of the entire 3D balance process.

With clearance secured, clinical study of X01 system is underway and XpandOrtho will now commence limited product launch to select U.S. surgeons. Future development may address its use in a range of orthopaedic procedures.

Sources: FDA 510(k) Releasable Database; company press releases and websites; articles in the public domain

¹Defined, for instance, as a company's first 510(k) clearance, first clearance in a segment that is new for that company, clearance for a type of device not formerly marketed by a company, etc.

Tags: 510(k) Clearance, Regulatory