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The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient MRI scans. The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those cleared in the manufacturer's clearances for the implant system.

The UNIKO PointCloud™ Knee Instruments are patient specific cutting guides which are machined from polyoxymethylene material by the by means of customized off-the-shelf software. These guides (also called jigs) aid the surgeon in making the initial distal femoral and the initial proximal tibial bone cuts along with establishing the references for femoral orientations used during total knee arthroplasty surgery. The surgeon then continues the surgical procedure with the conventional knee instrumentation provided by the implant manufacturer for the implant and size specific cuts required for implantation of the femoral and tibial total knee implants. The UNIKO PointCloud™ Knee Instruments are patient specific and are intended as single use instruments compatible with the TKA femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System.

The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for aligning of the implant are identifiable on patient imaging scans. The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System remain the same as those cleared in the manufacturer's clearance for the implant system.

The UNIKO PointCloud™ Knee Instruments use the TKA surqical plan that is output from the Vault® System Surgical Planning Software which was previously cleared by FDA through K124051. The surgeon plans a primary total knee replacement surgery using the Vault System and the output data file from the individualized surgical plan is utilized by the UNIKO PointCloud™ Knee Instruments (the subject of this submission) to create the necessary files for the production of patient specific cutting guides for the initial cuts to the distal femur and proximal tibia. The UNIKO PointCloud™ Knee Instruments are patient specific cutting guides which are machined from polyoxymethylene material by the by means of customized off-the-shelf software. These quides (also called jigs) aid the surgeon in making the initial distal femoral and the initial proximal tibial bone cuts along with establishing the references (for example AP, posterior condylar or transepicondylar (TEA) axis) for femoral orientations used during total knee arthroplasty surgery. The surgeon then continues the surgical procedure with the conventional knee instrumentation provided by the implant manufacturer for the implant and size specific cuts required for implantation of the femoral and tibial total knee implants. The UNIKO Knee Cutting Guides are patient specific and are intended as single use instruments compatible with TKA femoral and tibial components of the DJO Surgical EMPWR 3D Knee System.