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Let’s look at new technologies introduced in the trauma and robotic segments, including the much-awaited ROSA Shoulder System from Zimmer Biomet.
Trauma
GMReis VersaLock Volar Protect FLP
GMReis (filing as GM Dos Reis Industria E Comercio) | Quick-Radius Disposable Set, K231684
Submitted June 2023, granted January 2024
Primary predicate: GMReis Mini and Micro Fragments Reconstruction System, K182718
FYI: Quick-Radius represents a single-use implant and instrument set featuring the VersaLock Volar Protect FLP Plate for fixation of fractures of the distal radius. The device was developed to prevent irritation of the tendon of the flexor pollicis longus.
The FLP Plate design includes a central recess to minimize flexor pollicis longus tendon contact injury, even with the more distal positioning of the plate.
The plate is compatible with the company’s Versa cortical and variable angle locking screws (+/-15°) Versalock Ø2.4 and 2.7 mm.
The disposable set helps to decrease sterilization costs and processing time, reduce suppliers’ stock costs and delays due to set unavailability and increase efficiency in the O.R.
IlluminOss Medical Photodynamic Bone Stabilization System
IlluminOss Medical | Photodynamic Bone Stabilization System, K233436
Submitted October 2023, granted January 2024
Primary predicate: IlluminOss Photodynamic Bone Stabilization System, K202887
FYI: Clearance pertains to the Light-Emitting Diode (LED) Console to speed setting of the company’s patented, light-cured implants.
IlluminOss developed these balloon-like implants to support and repair fragile and geriatric bone. The implants are inserted through a minimally invasive procedure into the bone canal and infused with light-curing liquid. A fiber-optic cable transfers a specific wavelength of blue light from the Light Console to cure the implant and reduce the implant hardening time, in some cases by up to 50%.
The new design also reduces the console size by approximately 40% and incorporates LEDs as the light source instead of a metal halide bulb. LEDs last longer than bulbs and speed curing time of the liquid inside the balloons.
The system’s first procedure and CE Mark approval occurred in 2009, and it has been commercially available outside of the U.S. since 2010. In 2018, IlluminOss received FDA De Novo clearance for the system ahead of the U.S. product launch to treat impending and actual pathological fractures of the humerus, radius and ulna resulting from metastatic bone disease.
Robotics & Digital
Zimmer Biomet ROSA Shoulder System
Zimmer Biomet (filed as Orthosoft Inc. [D/B/A Zimmer CAS]) | ROSA Shoulder System, K233199
Submitted September 2023, granted February 2024
Primary predicate: Exactech (Blue Ortho) ExactechGPS Total Shoulder Application, Equinoxe Planning Software, K213546
FYI: ROSA Shoulder represents the world’s first robotic surgery system to support shoulder replacement, and the fourth application for the company’s ROSA Robotics portfolio, which includes ROSA Knee and ROSA Hip for total joint replacement.
ROSA Shoulder will work with the mymobility Digital Care Management Platform and supports a portfolio that includes the Identity Shoulder. The system joins the ZBEdge Dynamic Intelligence ecosystem of digital technologies, robotics and implants.
ROSA Shoulder does not require the placement of a pin in the center of the glenoid during positioning and can reproduce humeral head resectioning, easing the insertion of instruments into incisions.
ROSA Shoulder integrates with Signature ONE Surgical Planning 2.0, which uses a 3D image-based approach to visualization, surgical planning and patient-specific guide creation. During surgery, the platform provides surgeons with real-time, intraoperative data to help validate surgical plans for glenoid and humeral placement.
For the overall ROSA line, Zimmer Biomet expects 300 installations per year, 5% to 7% utilization growth annually and about one-third of all systems going into an ASC.
ROSA Shoulder is slated for U.S. launch in 2H24.
