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

In considering that the NASS 2019 Annual Meeting is less than two months 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. (I’ve included booth numbers for companies that have already reserved their space at the event.)

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

Integrity Implants | LineSider Spinal System, K190360

  • Filed February 2019, granted June 2019
  • Thoracolumbosacral pedicle screw for posterior, noncervical fixation in skeletally mature patients as an adjunct to fusion
  • Can be used in pediatric patients for certain indications
  • About the company:
    • Third clearance on its second product; first was FlareHawk, reportedly the first interbody that simultaneously expands in height, width and lordosis
    • Has raised $4.1MM in funding, to date

MiRus | GALILEO Spine Alignment Monitoring System, K182524 | NASS Booth 2234

  • Filed September 2019, granted June 2019
  • Wireless, real-time measurement and monitoring of segmental and global sagittal spine alignment
  • Battery-powered Orientation Sensing Modules (OSMs) are attached to vertebrae of interest with patient lying prone
  • OSMs contain inertial sensors that measure vertebral alignment changes and communicate information wirelessly to software that calculates sagittal plane spinal alignment parameters in real-time and displays the information on a touch screen tablet
  • First supporting technology clearance for MiRus; the company’s development roadmap includes implants, robotics, navigation and analytics

Omnia Medical | Omnia Medical Rotary PLIF System, K183659 | NASS Booth 2036

  • Filed December 2018, granted February 2019
  • PEEK-based interbody
  • Company’s second clearance, following a vertebral body replacement made from PEEK-OPTIMA HA enhanced polymer
  • About the company:
    • Interbodies under development include TLIF, ALIF and a standalone cervical device
    • Also distributes the PsiF for posterior sacroiliac fusion and various biologics (bone scaffold, DBM paste, amniotic fluid allograft)
    • Leadership has experience at Integra LifeSciences, REO Spineline, Theken Spine, UPex/The Progressive Orthopedic Company, Custom Spine

Republic Spine | Republic Spine Restore Cervical Interbody Fusion System, K190889

  • Filed April 2019, granted June 2019
  • Components made of titanium alloy PEEK (Evonik Vestakeep)
  • About the company:
    • Established in 2015 in Florida
    • Other products include the DarkStar Triple-lead pedicle screw system, DarkStar Deformity Plus featuring an HA blasted microporous surface and ReStore mineralized bone grafts
    • Leadership brings experience from CoreLink Surgical, Danek, Globus Medical, Medtronic, Miami Device Solutions, Orthofix, Stryker Spine

Silony Medical | Oyster ACIF Cage, K182608 | NASS Booth 1713

  • Filed September 2018, granted June 2019
  • Sterile, highly porous 3D-printed titanium intervertebral implant (mesh macrostructure 73% air, 27% titanium)
  • Anatomical and wedge-shaped design, can be used in combination with an anterior plate
    • Other cages, Dolfyn TLIF and Sharx PLIF/S TLIF, are marketed ex-U.S., not FDA-cleared

Spectrum Spine | Spectrum Spine Expandable Cages (SSEC), K173518

  • Filed November 2017, granted March 2019
  • Lumbar interbody devices made from PEEK, titanium alloy and tantalum markers
  • Expand in both height and angle and allow for packing of disc space with bone graft matrix
  • About the company:
    • Established in 2011 as an incubator to develop the surgeon founder’s inventions; by 2018,
    • Received three FDA 510(k) clearances including the Bridge MIS Laminoplasty System, Fenestrated Facet Screw and the Spinous Process Fusion System

Image courtesy of Evolution Spine



Julie A. Vetalice
is ORTHOWORLD's Editorial Assistant.

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