Strategic Orthopaedic-related 510(k)s Issued in July 2017: Interbody Focus

By Julie A. Vetalice

Twenty-two of the 39 products cleared under the orthopaedic panel in July were spine devices. Of the full 39, five fit our definition of strategic.1 Of those, three represented the company’s first orthopaedic 510(k) ever. These are marked with an asterisk, below.

EIT Cellular Titanium Cages (EIT Emerging Implant Technologies*), Lumbar Interbody System (HD LifeSciences*), Gemini-C Hybrid Cervical Interbody System (Osseus Fusion Systems), LumFuse-TP (Precifit Medical), Anchorman Tibial Ligament Fixation (Summit Medical)

In July, 13 clearances were gained for interbody fusion systems; I chose three of those for a closer look. Two are brand new entrants to the U.S. spine market, and the third represents the company's first IBF device.
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 510(k), 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

 

Sources: FDA 510(k) Releasable Database, company websites, information 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