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Regulatory

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

By Julie A. Vetalice

To meet your need to know who’s new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here’s what I found.


Ex-U.S. companies still like the U.S. joint reconstruction space.

ROOTLOC | Acculoc Total Knee | K170753
Seoul, South Korea | rootloc.com | Founded 2014

  • Fixed bearing, high flexion with posterior stabilized and cruciate retaining designs, cemented, comprising femoral component, tibial insert, tibial tray and patellar component
  • Company has developed a total hip and plans to add reconstructive devices for shoulder, elbow, wrist and hand



Ditto for U.S. spine; here’s an ex-U.S. company with another PEEK-based device.

SPINEMED | ACRON TLIF System | K171151
Wien, Austria | spinemed.at | Founded 2008

  • While no summary is available presently via FDA.gov, results of an online search suggest that the system was co-developed by SpineMED in Austria and ACRON Medical in Florida (acron-medical.com was under relaunch/development at time of publication).
  • The PEEK-OPTIMA-based technology is reported to have undergone three years of clinical validation in Austria, Switzerland and Germany.
  • The cage was developed to provide multiple insertion options and to maximize the contact between the implant vertebral body surface
  • A large footprint/load-bearing surface allows the implant to rest safely on the hardest bone to support stability and anchorage with inferior and superior endplates

 

There were more companies gaining first clearances for trauma products than in other segments (as often seems to be the case). So I chose two! Both have received some sort of funding to support next steps.

DIAMOND ORTHOPEDIC | Bone Fixation Screws and Pins | K180932
Charlotte, North Carolina | diamondorthopedic.com | Founded 2017

  • Sterile packaged faceted bone screws in headless compression, cortex and cannulated screws and pins and guidewires
  • Faceted design supports screw insertion into bone with less torque, thereby reducing the potential for microfracture
  • Company’s strategic goal is to penetrate orthopaedic group networks within ambulatory surgery centers
  • Received $3.5MM in seed funding in late 2017


PANTHER ORTHOPEDICS | Puma Fixation System | K171703
San Jose, California
(no website) | Founded 2017

  • Flexible Nitinol suture and PEEK anchor system used to treat ankle fractures, as well as ligament disruptions, soft tissue separation and hallux valgus of the foot
  • Unlike stiff metal screws, PUMA was designed to allow anatomical joint motion with continuous compression
  • In early 2017 announced a Series A investment from Medeon Biodesign, an incubator group based in Taiwan that develops medical devices for minimally invasive procedures across a range of specialties, including orthopaedics



Finally, in arthroscopy/soft tissue repair, here’s a startup that may make an interesting acquisition target.

AEVUMED | PHANTOM Suture Anchor | K180464
Wayne, Pennsylvania | aevumed.com | Founded 2013

  • PHANTOM is designed to offer intra-operative flexibility, especially in cases with low bone quality
  • Carries three sutures, reduces suture-pulling steps from eight to four and uses Micro-Thread micro-structure technology that may aid in pull-out strength by more than 260% vs. traditional anchors
  • In support of cost-effectiveness, PHANTOM eliminates the need for disposable suture passing instrumentation; estimated cost savings is reportedly $400/case
  • Second product in development is PHANTOM-X™, intended to address the 20% failure rate of rotator cuff surgeries by providing both biomechanical support and biological enhancement (planned 2019 launch)
  • Has raised $305,000 in total capital through own funds and angel investors; exit plan is reportedly buyout by a larger company in 3-5 years or IPO (market permitting)


Sources: Company websites, press releases, filings with the U.S. Securities & Exchange Commission, information in the public domain

Julie A. Vetalice is the Editorial Assistant for ORTHOWORLD.