The Vilex FUZETM. Dual Thread Screw & Intramedullary Nail in One Implant. The Ultimate TTC Arthrodesis Internal Fixator

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1 The Vilex FUZETM Dual Thread Screw & Intramedullary Nail in One Implant The Ultimate TTC Arthrodesis Internal Fixator

2 Introduction The Vilex FUZE TM TTC Arthrodesis Compression Nail combines the attributes of a compression screw and intramedullary nail. The screw feature achieves compression at the talo-tibial joint. The intramedullary nail feature allows the distribution of the patient s weight through four lateral-medial and two anterior-posterior solid locking screws. The FUZE head is embedded in the calcaneus. In addition, the proximal anterior hole is slanted 45 to allow a locking screw from the heel to the talus through FUZE itself. STEP-BY-STEP SURGICAL PROCEDURE 3 Drill Fuze Path Use a cannulated 7.5 mm drill with 2.5 mm cannulation to drill a hole from the plantar surface of the calcaneus through the talus and the articular surface of the tibia. Visualize the progress of the drill. The drill should reach the intramedullary canal of the tibia. 1 Make Incisions Make a lateral incision to expose the tibio-talar joint and the talocalcaneal joint. Prepare the arthrodesis sites surgically with a rasp or an osteotome to denude the arthrodesis sites for better union. Make a plantar incision to expose the calcaneus for the insertion of a 2.5x300 mm Steinman pin to serve as the guide wire for all subsequent steps. 2 Drive Guide Wire Align the tibia over the talus in the desired position before advancing the Steinman pin through either joint. The use of a C-arm is essential. The Steinman pin should be centered with respect to both the talus and the tibia. This step may require a slight forward shift of the tibia. Advance the Steinman pin 100 mm into the tibia. 4 Ream FUZE Path Remove the drill and use a cannulated orthopedic reamer to clear a path for the implant within the intramedullary canal. Start with the smallest reamer diameter and go to the next size depending on the FUZE size. The reamed hole diameter should not exceed the minor diameter of the implant s thread. 5 Manually Compress Joints Push the foot against the tibia to compress the joints manually and to close the tibio-talar and talo-calcaneal gaps.

3 6 Implant FUZE Insert the implant and drive it manually with the 5.5 mm hex cannulated screwdriver. STOP ADVANCING Before the implant head reaches the calcaneus, and while the implant head is at least 20 mm outside the foot, stop advancing the FUZE. 8 Lock Driver to FUZE Note the FUZE and the screwdriver lock together in only one position. Make sure there is no foreign material within the head cavity that might cause misalignment. 7 Remove Guide Wire Remove the Steinman pin altogether and lock the hex screwdriver to the FUZE. 9 Continue Advancing FUZE Advance the FUZE with the hex screwdriver. When the middle thread of the implant engages the distal tibia and the head engages the calcaneus, the tibio-talar and talo-calcaneal joints tighten at first. When the middle thread clears the talus, the implant compresses the joints. Advance the implant until the FUZE head is flush with the bone surface. The notch in the hex screwdriver handle should face towards the toes.

4 10 Attach Targeting Frame Attach the Targeting Frame to the FUZE head. Align the notch of the implant with the protrusion pin in the middle leg of the metal support of the Targeting Frame. Measure Measure the length of the screw needed. Remove the drill guide and the drill from the hole and drive the proper length 5.0 mm screw through the hole. The locking screws should engage both cortices. Targeting Frame Locked NOTE: The FUZE screwdriver assembly locks into the Targeting Frame in only one position. Tighten the locking nut to secure the Targeting Frame to the FUZE hex screwdriver assembly. Nut 12 Finish Placement of Locking Screws Finish the placement of cross screws as desired. Vilex recommends the insertion of at least 4 four screws: two distally through the tibia, one within the middle thread, and one through the calcaneus. 11 Introduce Locking Screws Insert the 150 mm drill guide P460-35A into a proximal Targeting Frame hole (corresponding to the leading tip of the implant). Insert a 3.5 mm drill, Z , into the drill guide and drive it into the tibia, through the FUZE, and into the distal wall of the tibia. The drilling provides a pilot hole for the 5.0 mm locking screws. All Screws Inserted

5 The Vilex FUZE System Self Drilling and Tapping Leading Tip INDICATIONS Ankle Arthrodesis Charcot Foot Arthritis Food Deformity Trauma FUZE SPECIFICATIONS Fuze Length: 150, 200, 250 Thread Diameter: 10, 12, 14 mm Material: Titanium or Stainless Steel Multi-axial stabilization with up to 6 bicortical locking screws 5.0 mm screws in mm lengths Radio translucent targeting tool Cannulated implant and instruments Cancellous Tibia Thread Rearfoot Arthrodesis Screw Slant ed 45 Threaded Head Cortical Vilex, Inc. 111 Moffitt Street McMinnville, TN USA Phone: Fax: info@vilex.com Visit us at Vilex, Inc. All rights reserved.