30 Day Trial

ORTHOWORLD » Other Articles of Interest

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

In considering that the NASS 2019 Annual Meeting is weeks away, I thought it an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. 

This round-up shares another entrant into the SI joint arena, a first clearance for an enabling technology for a company that already has implants on the market and additional details about some lesser-known companies to watch.

Biofusion Medical | SI-Restore Sacroiliac Joint Fixation System, K182919

  • First ortho-related 510(k)
  • Filed October 2018, granted January 2019
  • Cannulated titanium screw and washer affixed to screw head for full cortex engagement
  • Uses guide pins for accurate prep and placement of the implant
  • About the company: located in Texas, very limited information available; will be watchful for future activity


Evolution Spine | Whistler Modular Pedicle Screw, K182478

  • Filed September 2018, granted January 2019
  • All components made from titanium alloy, provided non-sterile and sterile forms
  • Manual instrumentation for implantation of the system available for conventional and minimally invasive procedure
  • About the company
  • Founded in 2015; located in Texas
  • Portfolio includes plates and interbody devices for ACDF, ALIF, TLIF and TPLIF approaches
  • Focused on incorporating innovative coatings and packaging to reduce infection potential

Read more at BONEZONE®.