FDA 510(k) Recap: AQrate, ROSA and First Clearances

In perusing the orthopedic FDA 510(k) clearances from January, eight caught my attention. Before we get to the new companies, let’s look more closely at two that we already know. Both Globus and Zimmer Biomet gained FDA 510(k) clearance for robotic systems—no surprise, but let’s make sure that we know the facts before we see them next month at AAOS.

Globus Medical | K182000, AQrate Robotic Assistance System (pictured above)

• Indicated for the assisted placement of spinal screws
• Used for spatial positioning and orientation of an instrument holder or instrument guide for open or percutaneous procedures
• Instruments and instrument guides are designed for use with the Medtronic StealthStation system
• Procured with Globus’ 2017 acquisition of KB Medical; at the time, leadership noted no plans to commercialize the robot but rather use it to shape future enhancements to the ExcelsiusGPS robotic guidance and navigation system

Zimmer Biomet | K182964, ROSA Knee System

• Designed to provide software-defined spatial boundaries for orientation and reference information to anatomical structures in the placement of knee implant components
• Robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories for use with a variety of Zimmer Biomet fixed bearing knee implants (e.g. certain NexGen, Persona and Vanguard systems)
• Proprietary X-Atlas imaging protocol provides x-ray based pre-op imaging to create a 3D model and plan of a patient’s bone anatomy
• Limited launch in 1H19

Now let’s meet some people with their first U.S. clearance to market products for spine, joint replacement, trauma and sports medicine. We’ll look at the technologies and the companies that will market them.

Spine

Additive Implants | K182477, Cervical Spacer | Founded 2015 | Phoenix, Arizona, U.S.

• • First FDA 510(k) clearance
  • For use with supplemental fixation and autogenous and/or allogeneic bone graft
  • Leveraging 3D titanium printing to integrate new geometries and materials
  • Company will introduce first product at the Congress of Neurological Surgeons’ Spine Summit in March 2019

Integrity Implants | K182114, FlareHawk Interbody Fusion System | Founded 2016 | Jupiter, Florida, U.S.

• First FDA 510(k) clearance
• Reportedly the first interbodies that simultaneously expand in height, width and lordosis
• 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
• In late 2017, entered into an agreement to license Sites Medical’s OsteoSync Ti highly-porous titanium scaffold technology for use in FlareHawk devices

Joint Replacement

b-One Ortho | K183025, MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, Patellar Component | Cedar Knolls, New Jersey, U.S. | Founded 2017

• First total hip and total knee systems were FDA 510(k) cleared in 2018; company continues to build out its line and is exhibiting at AAOS for the first time this year
• $20MM funding will support portfolio growth and expansion into ex-U.S. markets
• Management has mix of experience at Arthrex, Biomet, ConforMIS, DePuy Orthopaedics, Kanghui, OrthoPediatrics, Stryker, Trauson, Triangle, Zimmer, (Chief Scientific Officer designed Stryker’s Triathlon total knee)

Trauma

Ossio | K181180, OSSIO Pin Product Family | Boston, Massachusetts, U.S. and Caesarea, Israel | Founded 2014

• First FDA 510(k) clearance
• Proprietary bio-integrative OSSIOfiber material designed to provide stability and secure bone fixation that will leave no hardware behind; based on mineral fibers and bioresorbable polymer
• Preclinical studies indicate that full integration into surrounding anatomy occurs within 18-24 months, leaving only native bone
• Multi-center European clinical trial is evaluating OSSIOfiber Hammertoe Fixation Implant, to support CE Mark application in 2020
• Product launch slated for 2Q19 with focus on forefoot conditions; platform will have broad application across orthopedics, including distal extremities, trauma, sports medicine, reconstruction, pediatrics and spine in the form of pins, screws and plates

Sports Medicine

Pristine Surgical | K183165, Pristine Scope | Manchester, New Hampshire, U.S. | Founded 2013

• First FDA 510(k) clearance
• Single-use sterile digital HD camera for rigid arthroscopic and laparoscopic procedures in the hip, knee and shoulder; integrated camera and light
• Image processing unit is connected to Pristine’s digital health services platform
• Offered as a cost-effective alternative to traditional rod/lens scopes and rod/lens based imaging systems

Tigon Medical | K182507, Tigon Medical Tissue Anchors | Severna Park, Maryland, U.S. | Founded 2016

• First FDA 510(k) clearance
• Multiple-sized PEEK medial and lateral tissue anchors and a single sized labral anchor
• Manticore 5.5 mm and 6.5 mm and Labral 2.3mm or 2.9mm are customizable for use with either CuffTape or CuffCable

Sources: FDA.gov, company press releases, websites, information in the public domain; images courtesy of manufacturers

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