FDA 510(k) Recap: First Clearances for Companies in 1Q21

New year, new entrants to the U.S. orthopedic market. This installation of the 510(k) recap offers up companies based in the U.S., China and Switzerland, and spans four of the major industry segments: Joint Replacement, Spine, Trauma and Sports Medicine.

Featured first is BioPoly, a company long-known to the industry, which has received its first FDA clearance for a joint resurfacing technology.

We’ll continue to keep you apprised of the companies entering the U.S. market, throughout 2021.

Joint Replacement

BioPoly | BioPoly Great Toe Hemiarthroplasty Implant, K203634

  • Submitted December 2020, granted February 2021
  • Replaces a portion of the first metatarsal bone head and interacts with the opposite side of the joint, repairing only damaged tissue
  • BioPoly material is a microcomposite of UHMWPE and hyaluronic acid, yielding a strong, hydrophilic material
  • BioPoly surface properties are similar to cartilage; frictional forces between BioPoly and cartilage are nearly the same as that of cartilage-on-cartilage
  • First procedures expected by the end of 2Q21

About the company:

  • Established in 2007 in Fort Wayne, Indiana
  • Has raised over $15 million over five funding rounds from 2009 to 2016
  • First regulatory approval received in Europe in 2011 for partial knee resurfacing implants
  • BioPoly RS (ReSurfacing) devices are available for femoral condyle, trochlear facets, trochlear groove, patella and humeral head applications; development is underway for ankle (talar dome), Hill-Sachs/Bankart (shoulder), patellofemoral joint, hip, etc.


GetSet Surgical | GetSet Surgical GoPLF! Posterior Lateral Fusion System, K202505

  • Submitted August 2020, granted January 2021
  • Primary predicate: Medtronic CD HORIZON Spinal System, K090390
  • Implants are sterile packed, with a sterile inner cover facilitating a no-touch transfer and loading process to maintain optimal sterility and reduce risk of surgical infection
  • About the company:
    • Established in 2016 in Epalinges, Switzerland
    • Manufactures a range of pre-sterilized “Good to Go!” instrumentation and implants for spinal fixation and stabilization
    • Has also developed GOLIF! For lumbar interbody fusion
    • Leadership has experience at Globus Medical, Medtronic, Synaptive Medical (neurosurgical planning, navigation and robotic platforms), Synthes

ZSFab | ZSFab Cervical Interbody System, K202488 (pictured above)

  • Submitted August 2020, granted January 2021
  • Primary predicate: K2M Cascadia Interbody System, K160125
  • Additively-manufactured interbody fusion devices for cervical implantation
  • Features include porous lightweight lattice structures to enhance bone ingrowth, stability and comfort; serration designs to prevent cage migration and increase optimized bone contact; a wedged cage to match neighboring endplates
  • About the company:
    • Established in 2017; headquartered in Cambridge, Massachusetts with a facility in Beijing, China
    • Has also developed 3D-printed lumbar cages and a vertebral body replacement, as well as hip replacement components (not available in the U.S.)
    • Offers surgical planning and digital modeling services


Aike (Shanghai) Medical Instrument | Bfix Orthopedic External Fixator Systems, K200491

  • Submitted February 2020, granted January 2021
  • Primary predicate: Orthofix Galaxy External Fixation System, K113770
  • Adult fixator for bone stabilization in the lower limbs to treat open or closed fractures in long bones, bone defects or reconstructive procedures and limb lengthening
  • About the company:
    • Founded in 2009, based in Shanghai, China
    • Focused on external fixation throughout the body: upper and lower limbs, pelvis/hip (not all available in the U.S.)

Sequel Medical | Sequel External Fixation Device, K202833

  • Submitted September 2020, granted January 2021
  • Primary predicate: SH Pitkar Orthotools’ Pitkar External Fixation System, K190486
  • For use throughout the anatomy in adult and pediatric patients to treat open and closed fracture fixation, pseudoarthrosis or non-union of long bones, limb lengthening by epiphyseal or metaphyseal distraction, etc.
  • About the company:
    • Established in 2020 in Miami, Florida

Sports Medicine

CIT Ortho | C Scope Visualization System, K203526

  • Submitted December 2020, granted January 2021
  • Primary predicate: BioVision Technologies’ NeedleCam HD Visualization System, K143705
  • Provides illumination and visualization of an interior cavity of the body through a surgical opening in arthroscopic procedures
  • Comprises single-use rigid scope, reusable handpiece and tablet for viewing images
  • About the company:
    • Founded in 2003 in Westlake, Ohio
    • Subsidiary of Clear Image Technology, CIT Ortho focuses on advanced orthopedic solutions and micro visualization
    • Developing high quality, cost effective visualization solutions for use in multiple settings including office, surgery center and hospital
    • Clear Image Technology raised $500,000 in seed funding in 2012
    • CIT Ortho leadership brings experience from Biomet


Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.


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