FDA 510(k) Recap: First Clearances from Around the World

This month’s recap spans the globe and all five market segments, with companies based in Canada, India, Switzerland, the United Kingdom and the U.S.

Joint Replacement

Biorad Medisys | Genius/Genuin Total Knee, K200765 • Submitted March 2020, granted May 2021

  • Femoral component, tibial extension rod and tibial tray are Co-Cr-Mo alloy cast and primary finish from Orchid Orthopedic Solutions
  • Tibial insert and patella are UHMWPE imported from Orthoplastics
  • About the company:
    • Established in 2007 in Pune, India as Indovasive; company acquired the rights to manufacture the Indus knee, and the Orthovasive division emerged
    • In 2017, the companies got a brand refresh
    • Has also developed total hip and spine implants


SpineworxX | Born PT-LIF Cage HA, K202380

  • Submitted August 2020, granted February 2021
  • Primary predicate: Innovasis Px HA PEEK IBF System, K151785
  • For posterior lumbar vertebral body fusion of intervertebral disc segments in the range S1 to L1
  • Can be implanted through a median posterior approach or a transforaminal approach
  • Made from Invibio PEEK-OPTIMA HA Enhanced
  • Product is also CE Mark approved
  • About the company:
    • Founded in 2015 in St. Gallen, Switzerland
    • Has also developed the ACIF PIN for fusion in the cervical spine

Sports Medicine

Biorez | The BioBrace Implant, K203267

  • Submitted November 2020, granted April 2021
  • Primary predicate: Soft Tissue Regeneration STR GRAFT, K121216
  • Resorbable biocomposite soft tissue scaffold is intended to be used in a range of surgical procedures to reinforce soft tissue where weakness exists
  • Can be used with existing surgical techniques and instrumentation
  • Features a highly porous collagen matrix and resorbable PLLA microfilaments, yielding a bio-inductive scaffold with strength which is designed to both reinforce tendon and ligament repairs and promote healing
  • About the company:
    • Established in New Haven, Connecticut, USA in 2016; formerly known as Soft Tissue Regeneration
    • From 2008 to the present, has raised $26.4 million in funding
    • Leadership has experience from roles at Avitus Orthopaedics, Conventus Orthopaedics, Covidien, Mitek Sports Medicine, Rotation Medical, Trice Medical


Arbutus Medical | SteriTrak Skeletal Traction Pin, K203605

  • Submitted December 2020, granted April 2021
  • Primary predicate: DePuy Sterile Kirschner Wires and Steinmann Pins, K960385
  • SteriTrak kit supports the efficiency and speed of trauma centers and ERs when performing skeletal traction
  • Features a specialized pin and single-use drill cover in one package that includes a DeWalt drill, batteries and charger at no cost to the hospital
  • Single-use pre-sterilized cover removes the need to autoclave the power tool, and kits can be stored in the ER with no need for additional sterilizing
  • DrillCover Technology is a reusable liquid and pathogen-proof sterile enclosure that envelopes a non-sterile tool and fully seals the power transmission through the sterile barrier
  • About the company:
    • Formed in 2014 in Vancouver, British Columbia, Canada
    • Since 2015, has raised CAD $4.8 million (~USD $3.9 million) in funding


Biostone | si-Mochi Bone Void Filler, K202639

  • Submitted September 2020, granted April 2021
  • Predicate devices: Orthogem TriPore, K070132; Apatech Actifuse ABX M, K082575
  • Resorbable si-Mochi contains multi-porous bi-phase calcium phosphate ceramic granules, 1-2mm, suspended in an aqueous polymer carrier gel
  • About the company:
    • Established in 2016 in Nottingham, England, United Kingdom
    • A joint venture between Holymed Medical and Wollaton Medical Consultancy
    • Product portfolio includes synthetic bone graft for orthopedic, spinal and dental applications; hyaluronic-acid based resorbable polymer; a fully automated, remote controllable external Ilizarov cage for limb reconstruction and a magnetic drive extendable intramedullary nail for long bone deformation and fracture treatment
    • Chief Scientific Officer founded Orthogem to develop synthetic bone graft with a porous structure to accommodate the new bone formation down to the cellular level

Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.


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