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Regulatory

Spine Company 510(k)s from 1H16: Newcomers Aren’t All at NASS

Spine remains an active arena for market entrants, but attending the annual NASS meeting isn’t the only way to keep an eye on newcomers to the space.

Every month, ORTHOWORLD examines updates to FDA’s orthopaedic-related 510(k) database and highlights those clearances deemed “strategic,” defined as a company’s first 510(k) clearance, first clearance in a segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc. (You can view that monthly lineup in the ORTHOWORLD Members Area; it also comes to you by email once a month in ORTHOFLASH.)

In 1H16, we identified 21 companies with their first orthopaedic-related 510(k). Of these, ten were bestowed for spinal products. Of those ten companies, only four are slated to appear on the NASS floor this year, as noted below.

Who are these folks? Some have been around for years. What are they bringing to the operating table, today?




Astura Medical
asturamedical.com
Carlsbad, California, USA
Founded 2014
NASS Booth 1757

  • K152512, Half Dome Posterior Lumbar Interbody System, filed September 2015, decision date January 2016: PEEK and tantalum based, for use with autogenous bone graft and supplemental fixation
  • Three subsequent clearances YTD: anterior cervical and posterior fixation systems, cervical interbody spacer (All slated for display at NASS)
  • President has experience in sales/marketing for JNJ, Medtronic Spinal & Biologics, Orthofix, his own distributorship


     




Evolution Spine
Dallas, Texas, USA
Founded 2015

  • K160324, Cervical Interbody Fusion System, filed February 2016, decision date May 2016: PEEK and tantalum-based, for use with supplemental fixation and autograft, provided single-use and non-sterile


     




HT Medical
htspine.com
Tulsa, Oklahoma, USA
Founded 2014
NASS Booth 1068

  • K153615, NeoFuse™ HA Enhanced PLIF/TLIF interbody fusion system, filed December 2015,
    decision date May 2016: interbody cage featuring PEEK-OPTIMA® HA Enhanced polymer from Invibio®
  • Surgeons can modularly create a composite implant: at the center of the graft window, a
    footed cylindrical capture mechanism functions as graft retention feet when the cage
    is used without an insert, or may be used to retain a porous titanium insert (right, below)
  • CEO has industry experience at DePuy Spine, SeaSpine
  • Development pipeline includes products based on proprietary 3D-printed titanium additive technology from Additive Innovations (whose founder held leadership positions in engineering for Alphatec, Biomet, Integra LifeSciences, SeaSpine)
     

 




Hung Chun Bio-S
hc-bios.com
Kaohsiung City, Taiwan
Founded 2007
 

  • K151362, HC Spinal System, filed May 2015, decision date May 2016: for posterior non-cervical pedicle fixation as an adjunct to fusion
  • Initially provided molding and tooling equipment; now produces implantable devices under its own brand and to serve as OEM service provider
  • Claims to be the largest manufacturer of bone plates, screws and dental implants in Taiwan
  • Certified by GMP, FDA, CE Mark, approved by ISO 9001 and ISO 13485

     



Keos
Lancaster, Pennsylvania, USA
Founded 2014
 

  • K160631, Lumbar Interbody Fusion Device, filed March 2016, decision date July 2016: indicated for spinal fusion procedure at one or two contiguous levels, with supplemental fixation and autogenous bone graft, via TLIF or PLIF approach

     



Medtech Surgical acquired by Zimmer Biomet in July 2016
medtechsurgical.com
Montpelier, France
Founded 2002
NASS Booth 1531
 

  • K151511, Rosa Orthopedic Stereotaxic Instrument, Spine Indication, filed June 2015, decision date January 2016: indicated for use in the OR for placement of pedicle screws in lumbar vertebrae via posterior approach

     



NeuroPro Spinal Jaxx
spinaljaxx.com
Modesto, California, USA
Founded 2011
NASS Booth 2359
 

  • K152501, Spinal Jaxx interbody fusion device, filed September 2015, decision date June 2016: for use in the lumbosacral spine with autogenous bone graft and supplemental fixation; made of PEEK Optima, titanium alloy, commercially-pure titanium and Nitinol (Two versions available: with titanium endplates that contact the vertebral bodies and a PEEK implant body, or a titanium scaffold with interconnected pores on endplates for interface with bone)
  • Device is inserted into the collapsed disc space and expanded in situ; claims to have greater expansion capability than most competing products

     



Spinal Resources
Indian Harbour Beach, Florida, USA
Founded 2006
 

  • K152662, S-Wire, filed September 2015, decision date March 2016; no further information found in our search

     



Spine Innovation
Solana Beach, California, USA
Founded 2013
 

  • K153356, Interbody System, filed November 2015, decision date January 2016: PEEK, titanium and tantalum based, for use with autograft and supplemental fixation
  • Collaboration of three spinal surgeons and the engineering team from Cor Medical Ventures (whose founder has held leadership positions with Synthes Spine and N Spine, as well as development positions at Stryker Osteonics and JNJ Orthopaedics)
  • Has developed the Crossbar Lumbar Interbody Fusion implant and a novel retractor for use in lumbar fusion

     



SurgTech
Westlake, Ohio, USA
Founded 2014
 

  • K152200, Interbody Fusion Device, filed August 2015, decision date March 2016: PEEK and tantalum-based, for use with autogenous bone graft and supplemental fixation in the lumbar spine

     



Sources: FDA.gov, SEC.gov, articles in the public domain; images courtesy of manufacturers

 

 

Headed to NASS 2016?
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Also, refresh your knowledge on the spine market with the spine chapter in your Annual Report.

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