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FDA 510(k) Recap: Lesser-Known Companies and First Orthopedic Clearances

Of the 40 FDA 510(k) clearances in May for orthopedic products, over half were granted for spinal products: 24 of those, followed by nine for trauma, six in joint replacement and one orthobiologic product.

This recap highlights three companies with their first orthopedic 510(k) clearance, Axis Spine, Biocore9 and Joline, and one lesser-known company, OsteoCentric, to share players that may be new to you.

Axis Spine Technologies | Axis Spine Technologies ALIF, K200352

  • First FDA 510(k) clearance
  • Submitted February 2020
  • Primary predicate: Custom Spine Optimus ALIF System (K132596)
  • Used to treat Degenerative Disc Disease at one or two contiguous levels from L2 to S1, with supplemental fixation and bone graft

  • About the company:
    • Founded in 2017, based in St. Albans, Hertfordshire, England
    • Developed a platform technology of build-in situ modular cages as an alternative to conventional cage designs
    • Modular endplates are inserted in a closed position, atraumatically helping to preserve the structural integrity of the vertebral endplate
    • Received £830,000 (~USD $1.0 million) in new funding in 2Q20 to bring products to the spine market, with an initial focus on the U.S.
    • Leadership brings experience from ApaTech, DePuy International, NuVasive

Biocore9 | Humeral Resurfacing System, K193122

  • First FDA 510(k) clearance
  • Submitted November 2019
  • Primary predicate: Endotec Buechel-Pappas Humeral Head Resurfacing Component (K992394)
  • Indicated for hemi-arthroplasty only
  • Porous-coated components are for cemented use only
  • Components are available in five sizes with outside diameters from 40mm to 56mm in 4mm increments

  • About the company:
    • Formed in 2017, based in Whippany, New Jersey
    • Developed Biocore9 C-TiN-C coating using the latest improvements in thin film ceramic coatings technology, lean manufacturing methods and the application of proven design concepts and manufacturing principles

Joline | Joline Kyphoplasty System Allevo, K192449 (pictured)

  • First FDA 510(k) clearance
  • Submitted September 2019
  • Primary predicate: Osseon Osseoflex SB (K150607)
  • For reduction and fixation of fractures or creation of a void in cancellous bone in the spine during balloon kyphoplasty, with PMMA bone cement
  • Includes both single and double balloon catheter options that allow the introduction of one or two balloons into each pedicle at a time, for a total of two or four balloons per vertebrae
  • Allevo kit combinations are available for mono and double balloons, as well as a Basic/Economy kit (just the essentials and the Smart/Standard kit (does not include cement)

  • About the company:
    • Founded over 15 years ago; based in Hechingen, Germany
    • Also provides dialysis catheters and stents

OsteoCentric | Headless Compression Screw System, K200259

  • Submitted February 2020
  • Primary predicate: SMV Scientific Cannulated Screws (K170021)
    • Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis
    • Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments
    • System drills and guide wires are single use instruments
  • About the company:
    • Based in Austin, Texas
    • Founded in 2015 as SMV Scientific, changed name in 2018
    • Raised $12 million in secured debt financing in 2018
    • Developed Unifi patented bone preparation methods and thread geometries designed to preserve bone integrity while instantly interlocking an implant to bone, upon insertion
    • Unifi thread geometry is applicable to implants used in spine, sports medicine, extremities, trauma, joint recon, veterinary and dental procedures
    • Development projects include radial head replacement, glenoid and acetabular fixation and intramedullary applications of Unifi in limb salvage implants, as well as pedicle fastener implants
    • Leadership brings experience from DePuy Synthes, Facet Solutions, IMDS/CoorsTek Medical, LDR/Zimmer Biomet, MedicineLodge, Stryker

 Julie A. Vetalice
is ORTHOWORLD's Editorial Assistant.