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OPT-9 17.A method for measuring a gap between a femur and a tibia of a patient, the method comprising: 177 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 a needle connected to the balance indicator such that rotation of one of the superior plate and the inferior plate about an anterior-posterior axis of the patient moves the needle to point toward a mark on the face of the dial that reflects the orientation. 176 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 a dial comprising marks positioned on a face of the dial to indicate a measure of the orientation of the superior plate relative to the inferior plate; and 175 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 16. The gauge of Claim 10, further comprising a balance gauge coupled to the balance indicator, the balance gauge comprising: 174 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 15. The gauge of Claim 14, wherein the cam comprises a radial cam having a central axis and the contacting surface comprises a circumference of the radial cam about the central axis. 173 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 a follower connected to the superior body and biased and configured to contact the contacting surface of the cam such that rotation of the cam adjusts the displacement. 172 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 a cam connected to the inferior body by way of the driver, the cam comprising a contacting surface; and 171 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 a driver; 170 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 wherein the separator comprises: 169 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 a spring coupled to the shaft that biases one of the superior body and the inferior body in opposition to movement of the superior plate away from the inferior plate; and 168 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 a lock-out mechanism connected to the superior body and configured to prevent rotation of the superior plate connected to the balance indicator; 167 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 Figure 10A is a perspective view of a pin 158 of the gap gauge 100 of Figure 1A, according to one embodiment of the present disclosure. The pin 158 may be a cylindrical structure with a longitudinal axis 160. The pin 158 can include a proximal end 1002, a distal end 1004, and a middle 1006. In one embodiment, the proximal end 1002 connects to a balance gauge 168. For example, the proximal end 1002 may include a D-shaped cross section that includes a flat part 1008. In one embodiment, the D-shaped cross-section of the proximal end 1002 may be sized to accept a D-shaped opening in a needle 172 that can be slide over the proximal end 1002 and positioned for a balance indicator 126 and/or a balance gauge 168. 117 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 Once the gap gauge is positioned, the method 1200 may proceed to step 1220 in which the first plate and second plate are actuated apart such that the first plate contacts a resected surface of the femur and the second plate contacts a resected surface of the tibia. 125 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 The method 1200 may begin with a step 1210 in which a first plate (e.g., inferior plate 120) and a second plate (e.g., superior plate 118) of a gap gauge may be inserted between a femur and a tibia. In certain embodiments, the gap gauge may be positioned such that a pivot axis of a hinge may be aligned with an anterior-posterior axis of a patient. 124 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 Figure 12 illustrates a flowchart for a method 1200 for measuring a gap and/or balance status between a femur and a tibia of a patient, according to one embodiment of the present disclosure. In general, the method 1200 may include the use of gap gauge that includes both a separation indicator and a balance indicator 126. In certain embodiments, the gap gauge may also include a balance gauge. 123 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 As used herein, an "unset configuration" refers to an arrangement and/or relationship between a set screw and a pin such that the set screw permits rotation of the pin about a longitudinal axis of the pin. In the set configuration, the set screw 908 has been retracted within the opening 910 to disengage the planar surface 1014 of the section 1012. 122 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 Figures 11A and 11B are perspective views of a lock-out mechanism 130 of a gap gauge 100, according to one embodiment of the present disclosure. FIGURE 11A illustrates the lock-out mechanism 130 when the set screw 908 is in a set configuration. FIGURE 11B illustrates the lock-out mechanism 130 when the set screw 908 is in an unset configuration. As used herein, a "set configuration" refers to an arrangement and/or relationship between a set screw and a pin such that the set screw prevents rotation of the pin about a longitudinal axis of the pin. In the set configuration, the set screw 908 has been advanced within the opening 910 to engage the planar surface 1014 of the section 1012. 121 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 Figures 10B and 10C are side views of the pin 158 of Figure 10A, according to one embodiment of the present disclosure. FIGURE 10B illustrates and embodiment of a pin 158 that includes a first section 1016 having a larger diameter than a second section 1018. 120 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 In one embodiment, the middle 1006 may include a section 1012 that includes a planar surface 1014. The planar surface 1014 of the section 1012 may serve as part of the lock-out mechanism 130. For example in one embodiment, the set screw 908 may bias against the planar surface 1014 of the pin 158 to prevent rotation of the pin 158. In the illustrated embodiment, the section 1012 has a D-shaped cross-section. In one embodiment, the D-shaped cross-section of the section 1012 may be offset 90 degrees from a D-shaped cross-section of the proximal end 1002 that includes the flat part 1008. In one example embodiment, the 90-degree offset enables a needle 172 to register/measure no imbalance when the lock-out mechanism 130 is activated to prevent rotation of the pin 158. 119 Added by DJM 2 2021 2/17/21, 12:00 AM
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OPT-9 The distal end 1004 may serve as a pivot for a hinge 156 of the gap gauge 100. Alternatively, or in addition, the distal end 1004 may serve as a pivot for the balance indicator 126. The pivot may align with the longitudinal axis 160. In addition, the distal end 1004 and/or the middle 1006 may include one or more keyed sections 1010. In one embodiment, the keyed sections 1010 may be used for the pins 906 to connect the pin 158 to the pivot plate 148. 118 Added by DJM 2 2021 2/17/21, 12:00 AM

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