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New anatomical plates for fixing extremity fractures, an additively manufactured ankle replacement system and a sleeve for improving screw fixation during spine surgery highlight recent FDA 510(k) clearances. A new indication for the Remi robot rounds out this month’s round-up.
Joint Replacement
restor3d | Axiom PSR (Patient Specific Resection) System, K223326
Submitted October 2022, granted March 2023
Primary predicate: Medical Modeling, a 3D Systems Company, Vantage PSI System, K193432
FYI: The subject clearance is intended for use with the company’s Kinos Axiom Total Ankle. Axiom PSR is additively manufactured from titanium alloy, reportedly making it the first all-metal, patient-specific instrument system cleared for use with an ankle replacement system.
Axiom PSR guides incorporate a proprietary surface topography to ensure added stability at the bone contact interface. Additional features of the all-metal resection guides include integrated radiographic markers for fluoroscopic visualization and a limited footprint, which reduces soft tissue disruption.
Full commercial launch is slated for June 2023.
Spine
Woven Orthopedics Ogmend Implant Enhancement System
Woven Orthopedic Technologies | Ogmend Implant Enhancement System, K223075
Submitted September 2022, granted February 2023
Primary predicate: Woven Orthopedic Ogmend Implant Enhancement System, DEN180065
FYI: The subject clearance addresses the Ogmend system’s use in spine surgery. Ogmend is an implantable sleeve designed to aid screw fixation in challenging scenarios. It can be deployed in under two minutes and is used with a wide range of screw systems from a variety of suppliers.
In 2020, Ogmend received FDA De Novo clearance for use in long bone trauma surgery.
The system will be made available in the U.S. through a staged, regional release.
Trauma
Tyber Medical Anatomical Plating System
Tyber Medical | Anatomical Plating System, K222465
Submitted August 2022, granted March 2023
Primary predicate: Tyber Medical Anatomical Plating System, K203817
FYI: This clearance extends the breadth of Tyber’s Anatomical Plating System with 391 additional plate configurations, including 100 new plates targeting foot, ankle and wrist indications.
The system was also deemed safe to carry MR Conditional labeling by FDA, allowing it to be safely used in the MRI environment under certain tested conditions.
Robotics/Digital
REMI Robotic Navigation
Accelus (filed under Fusion Robotics) | Remi Robotic Navigation System, K223350
Submitted November 2022, granted March 2023
Primary predicate: Fusion Robotics Remi Robotic Navigation, K223070
FYI: The clearance relates to use of the Remi robot with GE OEC 9900 C-Arm fluoroscopic systems and means that it can be used with 2D and 3D imaging technology.
Remi is a targeting and navigation platform that assists surgeons with pedicle screw placement in the lumbar spine. The Remi 2D system utilizes a near-field optical tracking camera to track spinal instruments relative to an anatomical model based on a 3D imaging scan or 2D fluoroscopic images of the patient.
Remi was previously cleared by FDA in 2021 for use with the Medtronic O-arm 3D imaging system, and in 2022 for use with the GE OEC 3D, Ziehm Vision RFD 3D and Stryker Airo TruCT imaging systems.
Remi has a simplified workflow and a small, portable footprint, making it suitable for use in smaller hospitals and ASCs.
In mid-April, ATEC acquired all assets related to Remi for $55 million in cash.
