FDA 510(k) Recap: Companies Gain Trauma Device Clearances

Of the ~435 products cleared in FDA’s 510(k) database year-to-date, trauma/fracture fixation products address a little under one-fourth (~22%). As the Orthopedic Trauma Association holds its Annual Meeting this week, we look at companies that want to make a clinical difference in trauma surgery. The following five companies joined the ranks in the U.S. market during the year, with one from outside of the country and two gaining clearances on behalf of small startup OEMs.

AzurMeds | LTJ Screws and Washer, K200987

• Submitted April 2020, granted September 2020
• Primary predicate: Apogee OrthoSolutions Monster Screw System (K124027)
• Stainless steel 3.75mm solid and 4.5mm cannulated screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair/fixation; optional washers available for solid screws
• About the company:
  o Founded in 2019, based in Chicago, Illinois
  o First cases with product are slated for November 2020

Baat Medical Products | ANSER Clavicle Pin, K201830 (Pictured)

• Submitted July 2020, granted August 2020
• Primary predicate: DePuy Synthes Elastic Intramedullary Nail (EIN; also known as Titanium Elastic Nail or TEN) (K182783
• Three-part device for intramedullary fixation of mid-shaft clavicle fractures
• Main component is a nail placed within the medullary canal of the fractured clavicle, with a threaded medial end for fixation into the bone; at the lateral end an endcap is placed after insertion for lateral fixation of the pin
• All three devices have flexibility and can be curved to fit the anatomy
• Minimal hardware prominence means that the removal of hardware is almost never necessary
• Approved under the CE Mark in July 2020
• 1-year follow up results of the first case series of 20 patients treated with the Anser Clavicle Pin was published in the Journal of Shoulder and Elbow Surgery International in 2020; a second larger multicenter case series in the Netherlands is slated to begin January 2021
• About the company:
  o Founded in 1999, based in Hengelo, The Netherlands
  o Spun out of Twente University; now a global full-service provider of orthopedic product development services
  o Customers include DePuy Synthes, Silony Medical, Stryker, Waldemar Link, Zimmer Biomet
  o Obtained clearance on behalf of a partnership that includes Anser Implants (see below)
• About Anser Implants (anserimplants.com):
  o Surgeon-founded in 2015; also based in Hengelo
  o Once a Series A round has been completed, a U.S.-based C-corporation will be formed comprising current and investing partner(s)

GLW Medical Innovation | FusionFrame Ring Lock System, K200343 

• Submitted February 2020, granted September 2020
• Primary predicate: Fusion Medical Ring Lock System (K100857)
• An updated version of previously existing circular fixators specifically designed for the treatment of pathologies including stabilization of fractures and osteotomies; bone deformity correction of lower extremities; arthrodesis of the rear foot, mid foot and ankle joint; and limb lengthening in pediatric and adult patients
• About the company:
  o Founded in 2015, based in Englewood Cliffs, New Jersey with a location in Schleswig-Holstein, Germany
  o GLW funds, develops and commercializes startup companies exclusively focused on various segments of the orthopedic sector
  o Leadership brings experience from INBONE, Integra LifeSciences, SI-BONE, Stryker, Tornier, Wright Medical
  o Obtained clearance on behalf of Carbon22, a GLW portfolio company, for commercialization in the U.S. through exclusive distribution and education agreements with Novastep

OsteoCentric | Headless Compression Screw System, K200259

• Submitted February 2020, granted may 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:
  o Based in Austin, Texas
  o Founded in 2015 as SMV Scientific, changed name in 2018
  o Raised $12 million in secured debt financing in 2018
  o Developed Unifi patented bone preparation methods and thread geometries designed to preserve bone integrity while instantly interlocking an implant to bone, upon insertion
  o Unifi thread geometry is applicable to implants used in spine, sports medicine, extremities, trauma, joint recon, veterinary and dental procedures
  o 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
  o Leadership brings experience from DePuy Synthes, Facet Solutions, IMDS/CoorsTek Medical, LDR/Zimmer Biomet, MedicineLodge, Stryker

Retrofix Screws | RetroFix Screw, K200226

• Submitted January 2020, granted June 2020
• Primary predicate: Arthrosurface Bone Screws (K172383)
• Cannulated titanium alloy tapered screw intended for use as a stand-alone bone screw for internal fixation of ankle bone fractures
• About the company:
  o Formed in 2017, based in Salisbury, North Carolina

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