FDA 510(k) Recap: 9 First Clearances and Line Extensions

This month’s recap highlights devices of interest that received clearance in December 2019. I’ve focused on first clearances from companies new on our radar, like Augmedics, Avanti Orthopaedics, NanoOrtho, Nebula Surgical and Sonex Health, line extensions for Integra and Think Surgical and the latest devices from smaller companies like ExsoMed and Pantheon Spinal. For lesser-familiar companies, I’ve included a few facts and links, where available.

Joint Replacement

Integra LifeSciences | TITAN Reverse Shoulder System, K190588

• Submitted March 2019
• Primary predicate: Integra TITAN Reverse Shoulder, K161189
• Fourth clearance for the device
• Current submission addresses expansion of implant scope to include additional options for humeral liners made from highly crosslinked Ultra High Molecular Weight Polyethylene per ASTM F2565; existing liners are made from conventional UHMWPE per ASTM F648. The change in material allows for improved wear characteristics of the humeral liners.

NanoOrtho | NanoKnee, K190633

• First FDA 510(k) clearance
• Submitted March 2019
• Primary predicates: Smith & Nephew Journey Unicondylar Knee, K073175; Mako Restoris Porous Partial Knee, K133811
• Unicompartmental knee that includes porous coated and non-porous coated, cast CoCr, symmetric femoral components and titanium symmetric porous coated and non-porous coated tibial baseplate components, for use with or without bone cement
• About the company:
  • Founded 2018
  • One of the company principals brings engineering experience from Tornier, IMDS

Think Surgical | TSolution One Total Knee Application, K193135

• Submitted November 2019
• Primary predicate: Think Surgical TSolution One Total Knee, K191369
• 3-dimensional, graphical preoperative planning workstation and implementation tool for treatment of patients who require total joint arthroplasty
• Intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty
• Second clearance for this application, which was previously compatible with only the Zimmer Persona Knee
• The following changes have been made to the application: compatible implants (addition of the Corin Unity Knee, Aesculap Columbus Knee and DJO Surgical EMPOWR 3D Knee) and labeling (implant compatibility has been modified in the Indications for Use)

Spine

Augmedics | xvision Spine system (XVS), K190929

• First FDA 510(k) clearance
• Submitted April 2019
• Primary predicate: Medtronic Navigation StealthStation S8 Spine Software V1.0.0, K170011
• An aid for precisely locating anatomical structures in open or percutaneous spine procedures
• Allows surgeons to visualize 3D spinal anatomy as if they had “x-ray vision,” and to navigate instruments and implants while looking directly at the patient, rather than a remote screen
• Open platform technology from a 3D imaging and implant perspective, with a small O.R. footprint
• About the company:
  • Founded 2014
  • Raised a total of $10.1 million in funding over four rounds
  • President/CCO has 6+ years of experience at Intuitive Surgical and 10 at Mazor Robotics, where he commercialized the Mazor Robot
  • Plans to explore additional applications for xvision beyond spinal surgery

Pantheon Spinal | Pontus Interbody Fusion Device, K181548

• Submitted June 2019
• Primary predicate: Pantheon Spinal Interbody Fusion Device, K113781
• Composed of PEEK Zeniva ZA 500 with tantalum markers and a titanium alloy hub
• For use in the lumbar spine to treat degenerative disc disease
• Second FDA-cleared product since 2013

Trauma

Avanti Orthopaedics | Distal Radius and Forearm System, K191118

• First FDA 510(k) clearance
• Submitted April 2019
• Primary predicate: Biomet Distal Radius Volar Rim (DVR) Plating System, K132704
• Stainless steel system for fixation of fractures, osteotomies, malunions and nonunions involving the radius, ulna and carpals; wrist fusion plates may be used for wrist arthrodesis
• Includes precontoured plates, low profile design to minimize soft tissue irritation, low contact design to optimize blood supply, biplanar angulated screw holes for ease of drilling and to optimize fixation and subchrondral support

ExsoMed | Wrist Plating System, K192473

• Submitted September 2019
• Primary predicates: small fragment – Synthes Modular Hand System, K030310; large fragment – Synthes 3.5 and 4.5mm Locking Compression Plate System, K082807; locking and non-locking screw – Synthes Limited Contact Dynamic Hip Screw Implant K923613 and Synthes Titanium Limited Contact-Dynamic Hip Screw Implant for K953607
• Titanium plates and screws, provided non-sterile
• Fourth FDA-cleared product since 2017
• About the company:
  • Founded 2012 by surgeon entrepreneurs
  • Markets fusion products (screws, plates) for hand/wrist surgery
  • Managing Director former GM, International; Global Vice President of Sales & Marketing; Vice President of Marketing, International and Business Development at OrthAlign, growing the KneeAlign brand
  • Senior Engineering Designer has experience at NextStep Arthropedix (Extremities Division), Tornier, OrthoHelix

Nebula Surgical | Locking Bone Plates and Screws, Osteosynthesis Plating System, DHS Plating System, K191793

• First FDA 510(k) clearance
• Submitted July 2019
• Primary predicate: Synthes Volar Distal Radius Plate, K953644
• For treatment of fractures of various bones in adult patients, including the clavicle, pelvis, scapula, long and small bones (metacarpals, metatarsals, phalanges)
• About the company:
  • Founded 1999
  • Manufactures spine, trauma, sports medicine implants and instruments

Sports Medicine/Soft Tissue Repair

Sonex Health | SX-One MicroKnife, K192873 |

• First FDA 510(k) clearance
• Submitted October 2019
• Primary predicate: Orthomet Anatomically Guided Carpal Tunnel Release (CTR), K943873
• Disposable device that uses a blade to create space within the carpal tunnel and transect the transverse carpal ligament to treat carpal tunnel syndrome
• Device uses a micro-incision up to five times smaller than the incision made during traditional CTR surgery, that can be closed with a small adhesive bandage or strip instead of sutures or stitches
• About the company:
  • Founded 2014
  • Co-founded by two Mayo Clinic physicians
  • Seeks to provide ultrasound-guided surgery solutions with therapies that reduce invasiveness, improve safety and reduce the cost of care

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