Year in Review: Orthopedic Companies with First U.S. Products

One of my favorite lists that we compile every year is newer companies that hit our radar. Some we find through reporting the news, some in the FDA 510(k) database, others through investment conferences and even attendees of OMTEC.

This review pinpoints 17 companies that received their first FDA 510(k) clearances last year, so you’ll mostly find new names in the segments of Joint Replacement, Spine, Trauma Sports Medicine. We covered some of these 510(k)s as they were announced during 2019 but compiled them here into one list to see the breadth of products and companies that have reached a new stage of the commercialization process.

Joint Replacement

Engage Surgical | Orlando, Florida | Founded 2017

• November clearance for the Engage Partial Knee
• Permits all sizes of femur to be interchangeable with all sizes of tibial trays and associated tibial insert combinations
• Tibial tray and tibial anchor are titanium alloy, tibial insert is UHMWPE and femoral component is of CoCrMo alloy
• Product will launch in 2020
• Chief Operating Officer has experience at CoorsTek Medical, IMDS

FX Shoulder USA | Dallas, Texas | Founded 2018

• October clearance for a 32mm Glenosphere and Humeral Cup
• Subsidiary of FX Solutions SAS (France), which is a Viscogliosi Bros. portfolio company
• Parent company acquired shoulder assets of Small Bone Innovations in 2010
• Product lines include HUMERIS cementless anatomical/cementless reversible, HUMELOCK REVERSED cementless and cemented, HUMELOCK II cementless anatomical/cementless reversible/cemented reversible/cemented anatomical + graft/cemented anatomical + poly glenoid

Ignite Orthopedics | Warsaw, Indiana | Founded 2017

• May clearance for the Revolution Radial Head
• Product development and commercialization entity focused on shoulder and elbow replacement
• Leadership has experience at Biomet, Tornier, Wright Medical, Zimmer

NanoOrtho | Arroyo Grande, California | Founded 2019

• December clearance for NanoKnee unicondylar knee
• System includes porous coated and non-porous coated cast CoCr symmetric femoral components and titanium alloy symmetric, porous coated and non-porous coated tibial baseplate components
• Leadership has experience at IMDS

Spine

Additive Implants | Phoenix, Arizona | Founded 2015

• January clearance for the 3D-printed SureMAX Cervical Spacer
• Leadership has experience at Annulex, Danek, J&J Ethicon, Kyphon, Medtronic, Scient’x, Smith+Nephew, Zimmer Spine
• Company was one of 10 awardees in the Spring 2019 Arizona Innovation Challenge, a business plan competition that advances innovation and technology commercialization opportunities in Arizona by helping early-stage ventures scale

Addivation Medical | Monmouth Beach, New Jersey | Founded 2018

• July clearance for Cervical Interbody System
• Focused on development and commercialization of 3D printed off-the-shelf and patient-specific devices to treat degenerative, trauma and deformity spinal conditions
• General Manager’s industry experience includes upper management roles at Additive Orthopaedics, Zimmer Biomet; product management at Stryker

Amplify Surgical | Laguna Hills, California | Founded 2018

• October clearance for DualX Lumbar Intervertebral Body Fusion
• Device expands sequentially in lateral and then vertical directions
• Leadership has experience at ATEC, CTL Medical, NuVasive Specialized Orthopedics, Stryker, Titan Spine, VertiFlex and IntuitiveX, a life science incubator

Augmedics | Arlington Heights, Illinois | Founded 2014

• December clearance for xvision Spine System, which allows surgeons to see the patient’s anatomy through skin and tissue, as if they had x-ray vision
• System uses sensors and collects surgical information that can be connected to a big data system to analyze and process data
• Leadership has experience at Intuitive Surgical, Mazor Robotics, Medtronic, Richard Wolf, Stryker

CMF Medicon Surgical | Jacksonville, Florida | Founded 2006

• October clearance for MediExpand TL Expandable VBR
• Also manufactures craniomaxillofacial devices and instruments for use throughout orthopedics
• U.S. subsidiary of Germany-based Medicon eG, manufacturer of instruments and implants for a variety of medical applications

Elevation Spine | Monterey, California | Founded 2015

• August clearance for Saber-C Cervical Interbody Fusion Device
• Completed a Series A funding in 2018 for $2 million
• Leadership has experience at Arthrocare, ATEC, LDR Spine, Paradigm Spine, SpinalMotion

Integrity Implants | Jupiter, Florida | Founded 2016

• January clearance for FlareHawk Interbody Fusion System, the world’s first interbodies to expand in height, width and lordosis
• In late 2017, entered into an agreement to license Sites Medical’s OsteoSync Ti highly-porous titanium scaffold technology for use in FlareHawk devices
• Has since received clearance for the LineSider pedicle screw
• Raised $4.1MM in funding, to date
• Management has experience at Abbott Spine, Alevio Spine, Ascension Orthopedics, Baxano, Benvenue, Cutting Edge Spine, DePuy Synthes, Lanx, LDR, NuVasive, Stryker, VGI Medical, X-spine

restor3d | Durham, North Carolina | Founded 2017

• October clearance for ADI Cervical Interbody Fusion Device, under the company name Additive Device
• Additively manufactured device has a porous structure throughout the implant body, a circular window for the packing of graft material, a threaded hole for insertion, teeth on the surfaces of the perimeters to aid expulsion resistance and side windows on the walls of the implant
• Co-founded by Ken Gall, Professor of Mechanical Engineering at Duke University, and veteran in the study of materials processing, structure and mechanical properties
• Entered into an exclusive development and licensing agreement with SeaSpine; the two will leverage their specialties to develop interbodies for a wide range of surgical approaches, while driving both clinical and economic advantages; products slated to launch in 2H20
• Has since received clearance for ADI TiDAL Osteotomy Wedge
• Seeking to raise ~$1.5 million in funding

SpineWelding | Zurich, Switzerland | Founded 2004

• August clearance for Elaris Pedicle Screw
• While not a new company, this is the first FDA clearance applying proprietary BoneWelding technology that is designed to support load-bearing implants (non-FDA-cleared applications include trauma, sports medicine, CMF/dental, veterinary)
• Process uses ultrasonic energy to liquefy pre-defined polymeric components of the Elaris Pin, extruding them through the screw’s fenestrations and forming a bond between implant and bone
• Liquid polymer solidifies upon contact, forming a confined, solid ring around the screw tip; the bioresorbable polymer is gradually metabolized into H2O and carbon dioxide

Amplify Surgical

Augmedics

SpineWelding

Trauma

ActivOrtho | Plymouth, Minnesota | Founded 2017

• March clearance for a Nitinol Compression Screw
• Company has raised ~$2.4 million to date, with the last round of $1.1 million occurring in late 2019
• Has since received additional clearance for a Continuous Compression Screw
• Leadership includes a co-founder of and medical director for Conventus Orthopaedics

CurvaFix | Bellevue, Washington | Founded 2013

• March clearance for Intramedullary Rodscrew System, reportedly the only intramedullary implant capable of following the natural bone shape of curved bones, such as the pelvis
• Flexible device is implanted through a small incision into the intramedullary space, then converted into a rigid state to stabilize and repair the fracture
• U.S. launched slated for 2020
• Has raised $2.5 million of a planned $3.1 million, to date

Sports Medicine

Atreon Orthopedics | Columbus, Ohio | Founded 2016

• March clearance for Rotium Bioresorbable Wick, a synthetic bioresorbable scaffold for use in rotator cuff repair
• Atreon is a subsidiary of ParaGen Technologies, which is itself a joint venture between Nanofiber Solutions, the technology developer, and Ikove Venture Partners, which provides full operational support, market strategy and access to funding via a global network of investors
• Vice President Sales Business Development brings experience at Biomet and Medtronic Orthopedics

Sonex Health | Rochester, Minnesota | Founded 2014

• December clearance for SX-One MicroKnife to treat carpal tunnel syndrome via Micro-invasive Carpal Tunnel Release, disposable device uses a blade to create space within the carpal tunnel and transect the transverse carpal ligament
• 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
• 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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