FDA 510(k) Recap: Companies Gaining First Clearances in 2018 and 2019

I approached this article with the original intent of sharing all of the companies that received first orthopaedic-specific clearances in the second half of last year. My course changed when I encountered a few familiar names going in new directions—for instance, Maxx Orthopedics, the former Phygen and another new entity from a well-known entrepreneur.

Thus, on my mission to keep you informed, here is a sampling of those plus other companies gaining their first FDA 510(k) clearances to market products in the U.S. throughout 2018, and thus far in 2019.

Spine

Axis Orthopaedics | K181140, Chena Cervical PEEK Spacer | K180301, 5.5 Lumbar Pedicle Screw | K173867, Anterior Cervical Plate

  • Company formed in 2017 in Soldotna, Alaska; President/CEO’s experience includes Medtronic Spine & Biologics (including ex-U.S.)
  • While expanding its own-manufactured-product line, Axis is also marketing devices from Avitus Orthopaedics, Centric Medical, CrossRoads Extremities and RTI Surgical via strategic alliances

ClearView Orthopedic Development | K182339, Leucadia AutoLok Pedicle Screw System

  • While this is not the first clearance for the Leucadia AutoLok screw, it is the first 510(k) for this company, which was formerly Phygen; the original clearance for a Leucadia AutoLok device occurred in 2012
  • The subject system has undergone slight redesign of locking interfaces between the pedicle screw, the AutoLok pedicle screw head and the AutoLok set screw/locking nut to support maximum stability of the construct under worst case tolerances
   
  Curetiva
 

Curiteva Cervical Interbody
Fusion System

Curiteva | K181589, Lumbar Interbody Fusion System | K181549, Midline Anterior Cervical Plate | K181562, Anterior Cervical Plate | K181261, Cervical Interbody Fusion System 

  • Company established in 2017, HQ in Tanner, Alabama

GBS Commonwealth | K182059, Prase MIS Spinal Fixation System | K173645, Jasper Spinal Fixation System 

  • Founded in 2016 in Seoul, South Korea by former CEO of Aegis Spine
  • Other products in portfolio that are not FDA-cleared include a variety of PEEK interbody fusion cages and the HUVEX Interspinous Process Fusion System

Integrity Implants | K182114, FlareHawk Interbody Fusion System

  • Reportedly the first interbodies that simultaneously expand in height, width and lordosis
  • Founded in 2016 in Jupiter, Florida; management has experience at Abbott Spine, Alevio Spine, Ascension Orthopedics, Baxano, Benvenue, Cutting Edge Spine, DePuy Synthes, Lanx, LDR, NuVasive, Stryker, VGI Medical, X-spine
  • In late 2017, entered into an agreement to license Sites Medical’s OsteoSync Ti highly-porous titanium scaffold technology for use in FlareHawk devices

Joint Reconstruction

Maxx Orthopedics | K180973, Libertas Total Hip Replacement 

  • Acetabular cup and modular cemented/uncemented stems
  • First clearance for a hip product from the producer of the Freedom Knee system (Not the company’s first cleared product, but entry into the hip segment)

Trauma

MiRus | K182989, AURORA Screw System

  • Ti alloy-based screw to support repair of fractures, fusions and osteotomies of bones and bone fractures in the extremities
  • Also developing SMART™ implants with sensors to monitor wear, strain, temperature, etc. in hip, knee and spine implants (not FDA cleared), and investigating molybdenum-rhenium alloy material for its possible use in orthopaedic applications
  • Company launched in 2016, HQ in Marietta, Georgia; executive experience includes time at Carestream Health, DePuy Synthes, Exactech, RTI Surgical and Zimmer

OSSIO | K181180, OSSIOfiber Pin Product Family

  • Proprietary bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind; based on mineral fibers and bioresorbable polymer
  • Product launch slated for 2Q19 with focus on forefoot conditions;  platform will have broad application across orthopaedics, including distal extremities, trauma, sports medicine, reconstruction, pediatrics and spine in the form of pins, screws and plates
  • Founded in 2014, HQ in Woburn, Massachusetts and facility in Caesarea, Israel
  •          
            XBolt
           

    X-BOLT Hip Fracture Nailing and
    Plating Fixation System

X-Bolt Orthopaedics | K181640, X-BOLT Hip Fracture Nailing and Plating Fixation System

  • X-Bolt is designed to offer biomechanically stronger anchorage with rotational stability and minimum bone disruption, and it avoids spinning the femoral head; it is also easily reversible and removable using a standard orthopaedic screwdriver
  • These systems received CE Mark approval in 2011 and have been the subject of two large clinical trials, WHITE One (100 subjects) and WHITE Four (1,140 subjects), the latter of which is the largest ever trial comparing extracapsular hip fracture fixation devices
  • Published results of WHITE One indicate a 0% X-BOLT reoperation rate in unstable A2 and A3 fractures
  • Company established in 2007 in Dublin, Ireland

Sports Medicine

Responsive Arthroscopy | K180573, Interference Screw | K180951, Suture Anchor 

  • Company established in 2016 in Minneapolis, Minnesota; led by healthcare entrepreneur Doug Kohrs (Past President & CEO of Tornier and Managing Director of Responsive Orthopedics, which was sold to Medtronic in 2016)

Sources: FDA.gov, company websites, press releases, information in the public domain, etc.

*Images courtesy of manufacturers



Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant. Reach her by email.