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The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

Spine, trauma, spine, trauma—these two segments are leading 510(k)s this year. I’m compelled to highlight these segments again this month, in part, due to Globus Medical's activity. Globus (a ~$565MM company) has received clearance for its first two non-spinal trauma products. Seeking to diversify outside of spine, Globus plans to derive 15% of its revenue from trauma and robotics by 2020. In Globus’ 2Q17 earnings call, leadership affirmed that several trauma products planned for 2017 received FDA clearance, and were in full production mode. Later in the call, it was mentioned that they are about halfway through their core bag in terms of FDA clearances, so perhaps this is an indication of four trauma products initially, from Globus. I will keep you apprised.

Meanwhile, the continual entry of new companies into the U.S. spine and trauma markets does not come as a surprise, and frankly is expected to continue. Spine and trauma, the second and third largest orthopaedic market segments respectively, have not faced the same level of hospital scrutiny as the hip and knee segments. Below I present new spine products from EIT Emerging Implant Technologies, HD LifeSciences and Osseus Fusion Systems, and new trauma products from Globus Medical and HNM Total Recon/HNM Medical. I chose these from the list of recent 510(k) clearances primarily because, except for Globus and Osseus, they’re new entrants to the U.S. 

Spine

EIT Emerging Implant Technologies | Cellular Titanium Cervical and Lumbar Cages | K170503
Wurmlingen, Germany | U.S. HQ Atlanta, Georgia | eit-spine.de | Founded 2014

  • First FDA 510(k)
  • Additively-manufactured titanium scaffold structures have a porosity of 80% and pore size of 650 μm, mimicking trabecular bone structure and obviating the need for bone graft
  • Lumbar versions address ALIF, PLIF and TLIF approaches
  • Used in >10,000 cases in >15 countries, including Australia, France, Germany, Korea and the Netherlands
  • Developing 3D-printed patient specific implants to treat complex spinal disorders; first procedure was performed in 2015
  • In 2016, received an undisclosed funding from SHS, a German firm that typically invests €3MM to €5MM in initial financing rounds; proceeds were earmarked for international growth and product development
  • Leadership has a combined ~45 years of experience at numerous spine companies internationally, including Aesculap, InSpine, Link/Lima, Paradigm Spine, Spine Solutions (including the launch of ProDisc)
  • Has engaged GlobalMed Logistix and Ortho Sales Partners in the U.S. for inventory management, surgeon access, hospital approvals, etc.
  • Commercial launch began immediately


HD LifeSciences | Lumbar Interbody System | K170676
Stoneham, Massachusetts | hdlifesciences.com | Founded 2014

  • First FDA 510(k)
  • Additively-manufactured titanium implants in a variety of sizes and lordotic configurations
  • While less information is publicly available for this company, it appears to have been founded by entrepreneurial engineers with experience at SpineFrontier and Tri-Medics, a surgical instrument manufacturer. The company presently seeks to hire the first member of its engineering team.


Osseus Fusion Systems | Gemini-C Hybrid Cervical Interbody | K170844
Dallas, Texas | osseus.com | Founded 2012

  • Hybrid device incorporates porous titanium wafers with a radiolucent PEEK core
  • Third clearance; following a pedicle screw and an anterior cervical plate; has also developed a delivery system
  • Also distributes a zero-profile, revisable anchored cervical interbody made by Incite Innovations

 

Trauma

HNM Total Recon/HNM Medical | Draco Locking Screws | K163486
Miami, Florida | hnmmedical.com | Founded 2004

  • First FDA 510(k)
  • Headquartered in Florida, with manufacturing facilities in Tuttlingen, Germany
  • HNM is a German acronym for Haus Neuer Medizintecknik, which translates to House of New Medical Technologies
  • Portfolio includes German-grade surgical instruments, trauma products, extremities reconstruction implants, arthroscopic equipment, soft tissue repair devices and orthobiologics
  • The company markets its own branded products and has GPO contracts with GSA, Premier and Vizient, and its engineers also work with OEMs to develop products

Finally, Globus Medical gained FDA clearance for trauma products in April and May 2017. They are:

Globus Medical | ANTHEM Fracture System | K163361
Plates and screws made from titanium alloy, cobalt chromium molybdenum alloy or stainless steel, for use throughout the body; some may be used in pediatric, adolescent and small stature adult patients

Globus Medical | CAPTIVATE Compression Screws | K162825
Bone screws made from titanium alloy, cobalt chromium molybdenum alloy or stainless steel, for use throughout the body in pediatric and adult applications

Sources: FDA 510(k) Releasable Database, company websites, information in the public domain

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