From NASS: K2M Cranks Out Five New Products

One new product release during a trade show is a job well done. Two new device introductions make quite an impression. Three? Wow, the company has been pretty busy. What about five? Someone’s been busy.

Leesburg, Va.-based K2M Inc. was on a new-product-release roll at this year’s annual meeting of the North American Spine Society (NASS) in Chicago, Ill. The company doesn’t seem to be able to help itself. In addition to the five new products introduced at NASS, K2M has made five additional product releases in the past month.

The meeting in Chicago was a little like a coming-home party. Seven years ago, the company introduced its first device at the annual NASS confab, which also happened to be in the Windy City at that time as well.

Company executives have been relentless in pursuing their growth strategy, particularly since the group’s acquisition by private equity firm Welsh, Carson, Anderson & Stowe late last year, Lane Major, senior vice president of Global Marketing and Product Development, told Orthopedic Design & Technology.

K2M’s management team has been aggressive in its plans to become a player in the competitive spine market, going head to head with the “big boys” in the competitive $7 billion spinal implant market.

“We have been incredibly excited about this year’s NASS,” Major said. “Until you reach a certain size, a lot of folks don’t realize what’s going on, but we’ve had this kind of product development pace for quite some time. This year, in particular, was a new milestone. The transaction with Welsh Carson has allowed that growth to continue. Welsh Carson isn’t a company that comes in and tries to spin it out in a couple of years. It’s a long-term play. They’re looking for a company with a good infrastructure and platform.”

Major said it’s the company’s “entrepreneurial spirit” that made it an attractive buy and has fueled it’s product development efforts.

“If we lose that spirit, you become like so many others,” he said. “We have to maintain that enthusiasm and growth.”

Though the company doesn’t report its sales figures because its privately held, Major said the company has had 30 percent year over year growth. Moving forward, he said the company will continue to expand internal and through strategic partnerships and acquisitions.

“There’s a huge opportunity for organic growth and there are voids that we will fill in other ways. We’ve been looking at a number of alternatives and solutions,” Major said. Among those opportunities is the field of biologics, which he said the company has plans to enter.

While most of K2M’s manufacturing is outsourced, the company does do most of its own instrument manufacturing at a facility acquired a few years ago in Malvern, Pa.

“Our model has been very clear from day one and has never changed. For our product development—we have product managers and project engineers. Product managers are the CEOs of projects and project engineers are the CTOs (chief technology officers),” Major explained. “Those two roles, working with surgeons from around the world, fuel our innovation. You have to have the end-user involved from the beginning.”

He also noted that the company has brought in compliance and regulatory experts to ensure that the product development process and input from physicians is “done the right way.”

Products introduced during NASS included the Everest degenerative spinal system. It is a top-loading pedicle screw system that can accommodate titanium and cobalt chrome rods of two different diameters and a screw thread pitch designed to maximize both osteoporotic and dense bone fixation, according to the firm. Everest received 510(k) clearance from the U.S. Food and Drug Administration in April.

The company also expanded its Chesapeake line with the launch of an anterior-lumbar stabilization system, which is designed for the stabilization of the spine through an anterior approach. Manufactured from both biocompatible PEEK polymer and titanium, the system allows for anterior stabilization and fixation with a zero-profile design and using K2M’s Tifix locking technology.

K2M rolled out two new additions to its Aleutian line—the transforaminal-lumbar (TLIF) II interbody system and the anatomically narrow oblique interbody system. TLIF II includes an adjustable inserter, which allows for variable angulation of the implant from 0 to 55 degrees in-situ. The Anatomically-Narrow system provides a range of anatomically designed PEEK Interbodies for oblique implant placement through a transforaminal-lumbar approach. The system also comes with unique instrumentation to facilitate more efficient intraoperative use of the system, officials noted.

In addition, the company introduced the Serengeti complex spine minimally invasive system, which executives said would bringing K2M’s focus on complex spine and minimally invasive together into one system by providing surgeons the ability to address deformity, trauma and tumor, while promoting tissue preservation. The system features next-generation instrumentation to perform controlled reduction, manipulation, and above skin compression and distraction using the Serengeti retractor.

Also featured at NASS was technology that K2M recently acquired. The Blue Ridge hybrid cervical plate system recently was purchased the one-step locking technology used in the device from Amendia, a custom medical device developer and distributor in Marietta, Ga. The system features a nitinol locking mechanism that engages during screw insertion and requires no additional locking steps, according to K2M officials.