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FDA-Cleared Navigation, Planning and Robotic Systems

Just six weeks into 2020, orthopedic device companies large and small have set a tone affirming that enabling technologies will play a major focus in product development and commercialization this year.

The orthopedic industry’s three largest players—DePuy Synthes, Stryker and Zimmer Biomet—dedicated a portion of their 4Q earnings calls to discuss their strategies. Zimmer Biomet President and CEO Bryan Hanson’s summation of his company’s strategy is in sync with what we’ve heard from others. “We’ve taken a hard look at the R&D pipeline and started to bias more toward robotics and informatics. It doesn’t mean that we’re not going to continue to do implants,” he said. “But the fact is, most of the money now is shifting toward ROSA, mini robotics, informatics and efficiency in doing the procedure.”

Among the strategic announcements we’ve found of interest thus far in 2020, are Johnson & Johnson’s acquisition of Verb and startup Augmedics’ launch of its augmented reality surgical guidance.

In preparation for more announcements to come, we took stock of Orthopedic Stereotaxic Instruments, or enabling technologies, in FDA’s 510(k) database from 2018 to 2019.

This yielded a variety of tools, such as navigation, planning and robotic-assisted, for use across segments of joint replacement, spine and trauma. (Company names in parentheses represent the entity under which the clearance was received in FDA’s database.) The list illustrates that device companies of all sizes, as well as software startups, seek to bolster orthopedic procedures with new technologies.

Joint Replacement


Intellijoint Surgical | Intellijoint Navigation System, K191507 (cleared 2019)

  • First clearance granted in 2014, with numerous updates since
  • Latest submission adds Total Knee Arthroplasty to indications for use (cleared under K171525), allowing real-time measurements of varus/valgus angle, flexion/extension angle and resection depth for distal femur and proximal tibia cuts during TKA
  • Modifications include the addition of TKA-specific mechanical instruments and software
  • Intellijoint HIP helps perform intra-operative measurements including measurements of limb position, joint center-of-rotation and implant component positioning
  • Intellijoint KNEE assists with intra-operative measurements including alignment of instrumentation and bony cuts for implant component positioning

Ortoma | Ortoma Treatment Solution – OTS, K181449 (2019)

  • Stereotactic navigation system, offers positioning information in relation to individual patient anatomy before and during hip replacement procedures, including but not limited to THA through a posterior approach and preoperative planning and intraoperative navigated surgery for joint replacement with Stryker Exeter X3 Rimfit cups
  • Comprises the Ortoma Hip Plan (OHP), a 3D preoperative planning application, and Ortoma Hip Guide for real-time navigation for guidance of surgical tools and prosthetic components in relation to the preoperatively determined goal position
  • OHP has support for PACS (Picture Archiving Communication System) solutions already available at hospitals
  • Company launched the CE Marked OTS 4 for hip procedure planning, upgraded with the capability of artificial intelligence

Smith+Nephew (Blue Belt Technologies) | NAVIO Surgical System, K180271 (2018), K191223 (2019)

  • First clearance granted in 2012 under Blue Belt, with numerous updates since; company was acquired by Smith+Nephew in 2016
  • Assists in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during unicondylar knee replacement, patellofemoral arthroplasty and total knee arthroplasty; indicated for use with cemented implants only
  • K180271 incorporated a newer model of the optical tracking camera and an upgrade to the operating system
  • K191223 included updates to the NAVIO TKA instrument kit, including the addition of NAVIO system distal femur punches; updates to labeling; qualification of a new implant database for the ANTHEM Total Knee; and workflow, user interface and infrastructure updates to TKA software
  • For use with a wide range of implant systems: JOURNEY and JOURNEY II, LEGION, GENESIS II, STRIDE and ZUK

Stryker (MAKO Surgical) | Mako Total Hip Application, Mako Total Knee Application, K191998 (2019)

  • First cleared in 2006 for use in unicondylar knee procedures, with numerous updates since; Stryker acquired MAKO Surgical in 2013
  • Latest submission addresses the addition of a Pre-operative Planning Process – Treatment Design Application (TDA) is a new software tool implemented into the pre-operative planning process of Mako Total Hip and Total Knee procedures. The software tool is intended to accept CT imaging data and process it to generate the patient-specific 3D models and anatomic landmarks utilized for pre-operative implant planning.

Think Surgical | TSolution One Total Knee Application, K191369, K193135 (2019)

  • System first cleared in 2015 for application in THA, with numerous updates since; knee applications were added in 2019
  • Uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures
  • Robotic surgical tool, under the direction of the surgeon, implements the presurgical software plan
  • K191369 introduced the total knee application to TSolution, compatible with the Zimmer Biomet Persona Knee, while K193135 added compatibility with the Aesculap Columbus, Corin Unity and DJO Surgical EMPOWR 3D knee systems

Zimmer CAS (Orthosoft) | ROSA Knee System, K182964 (2019)

  • Stereotaxic instrumentation for TKA, to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components
  • The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible x-ray or MRI based surgical planning tools
  • Includes a robotic arm, optical sensor navigation system and accessories, software, surgical instruments and accessories
  • Compatible with NexGen, Persona and Vanguard implant lines

Spine

Globus Medical | ExcelsiusGPS, K190653 (2019) and K191100 (2019)

  • ExcelsiusGPS was originally cleared in 2017 indicated as a Robotic Positioning System for the placement of spinal and orthopedic bone screws, with numerous updates since then
  • K190653 addressed clearance of High Speed Drill Instruments for use with ExcelsiusGPS
  • K191100 addressed ExcelsiusGPS Spine 1.1 Interbody Module software and navigated instruments for access, preparation and placement of lumbar interbody fusion devices (lateral or posterior approaches)

NuVasive | NuVasive Pulse System, K180038 (2018)

  • At time of clearance, comprised Pulse NVM5, Pulse LessRay and Pulse Navigation:
    • NVM5 intra-op neurophysiologic monitoring
    • LessRay to reduce radiation exposure in the O.R. by as much as 80% vs. standard fluoroscopy
    • Navigation intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures; navigation may be used for pedicle screw or interbody device placement
    • Robotic component to launch in 2021

    SeaSpine | SeaSpine Navigation System, K172517 (2018)

    • Reusable instruments intended for use during the preparation and placement of SeaSpine screws to assist in precisely locating anatomical structures in either open or minimally invasive procedures
    • Designed for use with the Medtronic Stealth Station System
    • For use with SeaSpine’s FDA-cleared systems including Atoll, Coral/Coral MIS, Malibu Spinal System/Daytona, Malibu Spinal System, Daytona Small Stature, Mariner Spinal System, NewPort MIS, Sierra

    Spinal Elements | Spinal Elements Navigated Instruments, K190881 (2019)

    • Intended for preparation and placement of Spinal Elements screws (Mercury Fixation, Overwatch and Savannah) during spinal surgery to assist in precisely locating anatomical structures in open or minimally invasive procedures
    • Designed for use with the Medtronic StealthStation System

    Spine Wave | Spine Wave Navigated Instruments, K181596 (2018), K192526 (2019)

    • Intended for preparation and placement of Spine Wave screws (CapSure, Proficient Posterior Cervical, Sniper) to locate anatomical structures in open, minimally invasive or percutaneous procedures
    • Designed for use with the Medtronic StealthStation System
    • K192526 addresses the addition of use with the Salvo spine system screws

    Spineart | SPINEART Navigation Instrument System, K183630 (2019)

    • For use with the Medtronic StealthStation Navigation System to locate anatomical structures in open, minimally invasive or percutaneous procedures for preparation and placement of pedicle screws
    • For use with Spineart’s Romeo 2, Romeo 2 MIS and Perla Cervico-thoracic Fixation System

    Spineology | Spineology Navigation Instruments, K172518, K182345 (both 2018)

    • K172518 addressed initial instruments intended for use with Spineology’s Fortress, Palisade, Threshold and Threshold V2 Pedicular Fixation Systems and the Medtronic StealthStation System
    • K182345 addressed the addition of an adapter to Spineology’s FDA-cleared Spineology Navigation Instrument set

    Stryker (K2M) | Brainlab Compatible K2M Navigation Instruments, K181890 (2018), K192911 (2019)

    • Includes inserters, taps, probes and awls for use when implanting previously cleared components of DENALI, EVEREST, MESA and YUKON Spinal Systems, precisely locating anatomical structures in open or minimally invasive procedures
    • Instruments interface with the Brainlab Navigation System when used for navigation during spinal surgery
    • K192911 address a modification of the connection mechanism geometry and material to enhance user experience

    Zimmer Biomet (Medtech) | ROSA ONE Spine application, K182848 (2019), K192173 (2019)

    • The ROSA One device was originally cleared in early 2016 under Medtech; Zimmer Biomet acquired Medtech later that year
    • Robotized image-guided device that allows the user to plan the position of instruments or screws on medical images and offers accurate and reproducible guidance in accordance with the planning for placement of pedicle screws
    • Comprises two stands positioned around the operating table: a robot stand with a compact robot arm and a touchscreen, and a camera stand with an optical navigation system and a touchscreen
    • Different types of instruments may be attached to the end of the robot arm and changed according to the intended surgical procedure
    • K182848 addresses the expansion of the spinal application to the thoracolumbar region, as well as a spinous clamp with patient reference for the use during thoracolumbar spine interventions
    • K192173 adds an additional calibration step (software) and stand-alone arrays (instrumentation)

    Spine/Trauma

    Brainlab | Spine & Trauma Navigation, K183605, K191285 (both 2019)

    • Intended as an intra-op image-guided localization system to enable minimally invasive surgery
    • Links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patients pre- or intra- 2D or 3D image data
    • Software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools
    • K191285 addressed a proposed software modification to correct a display issue within the Spine & Trauma Navigation System software that can occur when a user changes navigation workflows; the issue was caused by an erroneous orientation of the anatomical slices that were displayed together with a projected instrument representation within axial and coronal/sagittal views of the image data, while the instrument tip was permanently correctly displayed


    Julie A. Vetalice
    is ORTHOWORLD’s Editorial Assistant.