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OMNI Receives FDA Clearance for Robotic Tissue Balancing Device on OMNIBotics Platform

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OMNIlife science received FDA 510(k) clearance to market Active Spacer, a proprietary robotic tissue balancing device for use with OMNIBotics® robotic-assisted total knee replacement (TKR) technology.

Active Spacer, which has been in clinical use in Australia since 1Q17, provides management of surrounding soft tissue with real-time feedback. The OMNIBotics system for TKR is driven by OMNI's proprietary ART™ software, and has been used to perform >16,000 procedures to date worldwide. This is an increase from the >10,000 milestone achieved by 4Q16 and >13,000 by 1Q17. 

ART software is customizable to any surgical approach and allows for intra-operative adjustments, and its 3D modeling technique eliminates the need for pre-op CT scans or x-rays. The system does not require a significant capital outlay, as it is offered through a pay-per-procedure model.

Sources: OMNIlife science, Inc.; ORTHOWORLD Inc.