OMNI Apex Blade Guide Instructions for Use

OMNI Apex Blade Guide IFU OMNI XK-05795 Praxim 4161-5500/1.0

IFU-4161-5500/1.0 REV C 31MAY19

Manufactured by: OMNIlife Science, Inc. (OMNI)

2797

480 Paramount Drive Raynham, MA 02767 USA www.omnils.com

For technical support call:  : 508-824-2444  : 508-822-6030

Medical Device Safety Service GmbH Schiffgraben 41 30175 Hannover Germany

INTENDED USE The OMNI Apex Blade Guide is intended to integrate the functionality of the Praxim Blade Guide (41605000) into the Praxim Drill Guide (4161-5400). This allows a user to insert the OMNI Apex Blade Guide into the anterior cutting slot of a peg-less femoral 4-in-1 cutting guide (XK-00081 through XK-00086), and to navigate the position of the 4-in-1 guide using the Anterior Cut Validation page of the ART knee Software.

REFERENCES  

IFU-036: OMNI ART KNEE APPLICATION AND IBLOCK (OMNIBotics Total Knee) IFU IFU-039: OMNI ART AND IBLOCK SYSTEM INSTRUMENTATION IFU

INSTRUCTIONS FOR USE In order to use the OMNI Apex Blade Guide the “NanoBlock + Drill Guide” option must be selected as per section 5.3 of IFU-036. In addition, under advanced options in section 5.3, the “cut validation follows cut navigation” option must be selected. The OMNI Apex Blade Guide can be utilized per the following instructions: 

The OMNI Apex Blade Guide’s instructions for use are the same as sections 4.15, and 4.17 of the IFU-036 with the following changes:  All references to “the OMNI Apex Drill Guide (#4161-5400)” are replaced with “the OMNI Apex Blade Guide (#4161-5500/1.0)”

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Alternatively, the blade guide can be used to navigate the 4-in-1 cutting guide after performing the distal cut:  Insert the blade guide into the anterior cutting slot of the appropriate peg-less 4-in-1 cutting guide  Using the Anterior Cut Validation page of the ART knee software, navigate and pin the 4-in-1 cutting guide  Remove the blade guide and perform femoral AP cuts