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FDA 510(k) Recap: Adjacent Markets, Additive, Surgical Platforms

I scan the FDA 510(k) database each month, seeking out interesting angles, new companies on the scene, application of new approaches and materials, offerings that support supply chain optimization and anything that illustrates a company’s strategic approach to growth. In this recap, we’ll observe three spine and three trauma products of interest that have gained clearance since the start of 2019.

They include a spine cage from a traditionally biologics company, a foot/ankle device from a spine company and high-profile technologies of interest—additive and computer assisted surgery products

I’d be remiss if I didn’t note that coverage of Zimmer Biomet’s ROSA ONE Spine clearance is available here.

Spine

Additive Implants | K182477, SureMAX Cervical Spacer

  • First FDA 510(k)
  • Submitted in September 2018, cleared January 2019
  • For use with supplemental fixation and autogenous and/or allogeneic bone graft; the hyperlordotic implants must be used with an anterior cervical plate
  • Additively manufactured from titanium alloy
  • Engineered to support stability at the bone/implant interface throughout healing
  • Additively manufactured with a roughened porous surface and features on superior, inferior and lateral aspects to engage bone with vertebral endplates
  • Company:
    • Founded 2015
    • Leadership has experience at Annulex, Danek, Ethicon, Kyphon, Medtronic, Scient’x, Smith & Nephew, Spinal Concepts, Zimmer Spine

   
  additive implant suremaxx cervical
 

Additive Implants SureMAX Cervical Spacer

   nvision biomedical vector adjust
 

Nvision Biomedical Vector

Alphatec Spine (SafeOp Surgical) | K182542, EPAD 2 Neuromonitoring System

  • First cleared under SafeOp in 2014; Alphatec acquired them in 2018
  • Submitted in September 2018, cleared February 2019
  • For use in real-time intra-op nerve location and health assessment
  • Comprises the EPAD 2 Headbox and power supply, a tablet computer, electrodes, stimulating probe or clip and cables
  • The Headbox manages stimulation and acquisition of signals for intra-op neurophysiologic monitoring, and is clipped to the bed in the O.R.
  • This clearance expands the application with additional advanced algorithms for electromyography
  • First focus will be minimally invasive lateral procedures; other surgical approaches to come over time
  • Indications cited in the clearance include use in intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous lumbar, thoracic and cervical surgical procedures
  • This represents the first offering from the company’s Alpha Informatix platform, which will give the company a differentiated technology scalable to all spinal approaches
  • Full launch to occur within 1H19

Kuros Biosciences | K183092, Transforaminal Lumbar Interbody Fusion Cage

  • Submitted in November 2018, cleared March 2019
  • Represents the first hardware cleared for Kuros, which is primarily a developer of synthetic bone graft substitutes and other orthobiologic products
  • Composed of PEEK, with tantalum markers
  • To be used with KUR-113, Kuros’ Fibrin-PTH product candidate for spinal fusion
  • Clinical trials of the system are now underway

 
Trauma

Additive Orthopaedics | K183011, Patient Specific 3D Printed Locking Lattice Plates

  • Submitted in October 2018, cleared in January 2019
  • Titanium devices designed to address stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle
  • This product and the company’s Patient Specific 3D Printed Bone Segments will be the cornerstone of Game Plan, an integrated surgical planning system that will launch within 2019

Gramercy Extremity Orthopedics | K182212, GEO Staple System

  • Submitted in August 2018, cleared January 2019
  • Nitinol-based device for fixation of small bone fragments, osteotomies and joint arthrodesis
  • System offers symmetric or asymmetric, barbed or smooth staples in various sizes, each delivered in the relaxed position and preloaded on individual inserters
  • Implants and instruments provided sterile, with instruments in single-use kits
  • Available on the GEO CART mobile storage and point-of-sale system that houses 2,000+ sterile-packed instruments and implants that are tracked and managed with RFID technology

 
Nvision Biomedical Technologies | K183055, Vector Hammertoe Correction System

  • Submitted in November 2018, cleared February 2019
  • Reportedly the first foot/ankle implant to be made from PEEK-OPTIMA HA Enhanced polymer
  • Also the first lower extremity (Proximal Interphalangeal Joint Arthrodesis) implant to use Structural Encoding technology to enable UDI; embeds the entire history of the device for access by x-ray imaging
  • An alternative to convential K-wire treatment of hammertoe
  • Represents Nvision’s entry into extremities trauma market, expanding from its previous focus on spine

 

Sources: FDA.gov, company press releases, websites, information in the public domain



Julie A. Vetalice
is ORTHOWORLD’s Editorial Assistant.

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