Year in Review: First 510(k)s in 2016

By Julie A. Vetalice

Every month, we examine FDA’s 510(k) database to learn about products heading to market and the companies that intend to bring them there. Here, we’ve captured highlights from that work over the last year.

The following 18 companies received their first FDA 510(k) in 2016. What’s interesting is that some companies like CG Bio, Meril Life Sciences and Overmed were founded in 2006—a decade ago. Another, such as Onkos Surgical, was founded as recently as 2015.

Also of note, 13 of the 18 companies are U.S.-based, with the remaining five representing Canada, South Korea, India and Italy.

Each listing shares the company’s location and tells a little about them, with select notable aspects of the technology cleared or the company generally. We also share the market segment under which the product is best classified.

One final interesting note: eight of the 18 products are trauma-related; five are spine-related. A total hip, total knee and total shoulder are also found in the list.

7D Surgical | Toronto, Ontario, Canada | Founded: 2009
Segment: Spine

  • K162375: Envision 3D, stereotaxic image guided surgical navigation system for use in spine surgery (also known as MvIGS)
  • Using pre-op CT or MRI image (not x-ray or intra-op CT), employs 3D patient digitization to provide surgical guidance accuracy

Additive Orthopaedics | Little Silver, New Jersey, USA | Founded: 2015
Segment: Trauma

  • K160264: Hammertoe Correction System
  • Features a roughened AddBone additively-manufactured surface for bony ongrowth and fixation, and the OrthoBarb one-way helical barb design to support fixation
  • Received second 510(k) for bone wedge within 2016

AmorChem | Montreal, Quebec, Canada | Founded: 2011
Segment: Trauma

  • K160791: Titanium porous variable pitch, fully threaded, cannulated headless compression screw
  • AmorChem is a venture capital fund investing in life science projects from Quebec-based universities and research centers
  • Portfolio also includes a greater trochanter fixation system

Astura Medical | Carlsbad, California, USA | Founded: 2014
Segment: Spine

  • K152512: Half Dome PLIF System
  • Principals have experience from Alphatec, Johnson & Johnson, Medtronic, Next Orthosurgical, Orthofix
  • Received three additional 510(k)s within 2016
  • Product portfolio includes biologics, hardware, neurological monitoring
  • President has experience in sales/marketing for JNJ, Medtronic Spinal & Biologics, Orthofix, his own distributorship

Catalyst OrthoScience | Naples, Florida, USA | Founded: 2014
Segment: Joint Reconstruction, Extremities

  • K152825: CSR Shoulder System, a bone-preserving total shoulder that requires one instrument tray
  • Implant is reportedly smaller and requires less bone removal than other current options
  • Leadership has experience at Arthrex, Biomet, RTI Surgical, Vivex Biomedical, Walter Lorenz, Zimmer
  • Received ~$1.0MM angel investment during 2016

CG Bio | Seongnam-Si, Korea | Founded: 2006
Segment: Spine

  • K160731: LumFix posterior spinal fixation system
  • Company manufactures and distributes portfolio of allograft and synthetic bone grafts, spinal implants, growth factors, etc.
  • Seeks to build presence in U.S. market, Latin America, China, Japan and India

Coracoid Solutions | Park City, Utah, USA | Founded: 2015
Segment: Arthroscopy/Soft Tissue

  • K153211: M-Fix Acromioclavicular Device, comprising a polyethylene terephthalate band that may be tensioned and secured with the integrated, low-profile titanium or stainless steel connector/button; requires no drilling
  • Portfolio company of IdeaMD, an orthopaedic product development firm
  • Executive experience at Benvenue Medical, Cradle Medical (acquired by DJO), Eleven Blade (acquired by ArthroCare)

Epic Extremity | Cranberry Township, Pennsylvania, USA | Founded: 2012
Segment: Trauma

  • K153333: Cannulated Screw System
  • Received subsequent 510(k) for an extremity plate within 2016
  • Executive experience at NovoSource, R&B Medical
  • Company founded to offer lowest-total-cost implants

First Ray | Logan, Utah, USA | Founded: 2014
Segment: Trauma

  • K153622: Internal Bone Staple, completely contained within bone; creates controlled and evenly-distributed compression across opposing bone surfaces
  • Two additional 510(k)s in 2016 for Bicortical Fixation Screw/Washer Nut, Flip Button Suture Anchor
  • Portfolio company of incubator, Surgical Frontiers

HT Medical | Tulsa, Oklahoma, USA | Founded: 2014
Segment: Spine

  • K153615: Neofuse HA Enhanced PLIF/TLIF: 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
  • 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)

Meril Life Sciences/Meril Healthcare | Vapi, Gujarat, India | Founded: 2006
Segment: Joint Reconstruction, Knee

  • K160771, DESTINKEE cemented total knee, developed to suit Asian patient anatomy (no overhang); bone preserving; offers a high-flex design, all poly and metal back
  • Products distributed by Maxx Medical/Maxx Orthopedics

NeuroPro Spinal Jaxx | Modesto, California, USA | Founded: 2011
Segment: Spine

  • K152501: Spinal Jaxx interbody fusion device 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)
  • Claims greater expansion capability than most competing products

NextStep Arthropedix
Akron, Ohio, USA | Founded: 2013
Segment: Joint Reconstruction, Hip

  • K161184: iNSitu cementless total hip
  • Additively manufactured via Electron Beam Melting; includes a highly cross-linked Vitamin E UHMWPE bearing
  • Executive leadership experience includes Acromed (acquired by DePuy), Biomet Microfixation, DePuy Orthopaedics, Integra Spine (acquirer of Theken Spine), Micropulse, Orthohelix (acquired by Tornier), VOT Solutions, various Theken companies
  • Subsidiary of Theken Companies (under which the product is listed in FDA’s database)

Onkos Surgical | Parsippany, New Jersey, USA | Founded: 2015
Segment: Trauma

  • K161520: Eleos Limb Salvage System for treatment of bone loss due to cancer, trauma or previous surgical procedures
  • Full launch slated for 1Q17
  • Company focuses solely on the adult and pediatric surgical oncology market
  • Partnered with MicroPort Orthopedics for product distribution in China, and with Vivex Biomedical for access to hard and soft tissue biologics for use in reconstruction
  • Leadership experience includes Biomet, DJO, EDGE Orthopedics, KMI, OrthAlign, Stryker

Overmed | Milan, Italy | Founded: 2006
Segment: Trauma

  • K143596: MiniARS titanium screws for small bone fragments, arthrodesis, osteotomies

Phalanx Innovations
Marietta, Georgia, USA | Founded: 2014
Segment: Trauma

  • K160194: Starfuse Interphalangeal Pin for osteotomies, arthrodeses, reconstruction in the lesser digits of the toes
  • Received second 510(k) within 2016 for the Osteobullet Compression Screw
  • Device development and project management company
  • Leadership has experience at Amendia and Valeris Medical

Riverpoint Medical | Portland, Oregon, USA | Founded: 2008
Segment: Arthroscopy/Soft Tissue

  • K160655: OrthoButton CL, braided UHMWPE with a titanium plate
  • Company is an OEM and contract manufacturer, specializing in implantable bioabsorbable fibers, surgical lighting, etc. for healthcare and veterinary markets

Syntorr | Palo Alto, California, USA | Founded: 2009
Segment: Trauma

  • K161489: K-Wire and Pin System
  • Device development company, holds patents on various orthopaedic implants that have been licensed to major orthopaedic companies and have wide clinical use
  • Leadership has also co-developed the UltraCL prosthetic cruciate ligament with a veterinary orthopaedic company in Switzerland; seeking to evaluate canine results and assess for human application

Sources: FDA 510(k) Premarket Notification database, company websites, press releases, information in the public domain

Tags: 510(k) Clearance, Regulatory