RibFix Blu. Thoracic Fixation System

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RibFix Blu RibFix Blu Thoracic Fixation System

The New Era of Rib Fixation Begins Now Designed by Trauma Surgeons for Trauma Surgeons Your work matters and so do your patients. We are continually engineering new tools and techniques to help improve your efficiency in the operating room. The RibFix Blu Thoracic Fixation System is designed with this in mind. The system s innovative plate-to-bone approximation tools allow for the precise placement of plates along the rib, and unique plate-contouring instrumentation eliminates the need to remove the implant from the surgical field - saving you precious time when minutes matter. Indications RibFix Blu is indicated for use in the stabilization and rigid fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma or planned osteotomies. The system may be used in normal and poor bone to promote union.

RibFix Blu Thoracic Fixation System A Comprehensive, Customizable Rib Fixation System The RibFix Blu Thoracic Fixation System includes a selection of straight and pre-contoured plates and self-drilling as well as self-tapping screws, making the system easy to master in any surgical setting.

Unique Instruments Plate-to-Bone Approximation Tools Innovative temporary fixation screws and bayoneted plate-holding forceps reduce the plate flush to bone and aid with precise placement along the midline of the rib - freeing your hands to implant self-drilling screws. Temporary Fixation Screws Temporary Fixation Screw in Place Without Driver Bayoneted Plate-Holding Forceps

RibFix Blu - Features and Benefits Plate-Contouring Tools Engineered with the goal of expanding bend options, the RibFix Blu Thoracic Fixation System includes threaded and in-situ plate benders. The benders allow for adjustments to the plate in all planes - including torsional - eliminating the need to remove the implant from the surgical field. Threaded Plate Benders In-Situ Plate Benders In-Situ Plate Adjustments MIS Instrumentation The RibFix Blu Thoracic Fixation System offers minimally-invasive solutions for plating hard-to-reach rib fractures. Proximal posterior fractures that are generally inaccessible can be plated via trans-scapular or sub-scapular approaches using the MIS instrumentation. Both methods mobilize the scapula for easier maneuverability. Contra-Angle Screwdriver Trocar Assembly

Innovative Implant and Screw Design Implant Design Features Pre-contoured in two planes to fit the average anatomical rib shape Narrow plate design for easy alignment and minimal intra-operative contouring Universal plate selection - any plate can be applied to any rib on either the left or right side 1.6mm profile and deep counter-sunk screw holes provide minimal palpability Commercially-pure titanium for flexibility and strength 30cm In-plane bend radius Deep counter-sink of threaded screw hole 20cm Out-of-plane bend radius Single-sided design

RibFix Blu - Features and Benefits Self-Drilling Screw Self-drilling screws designed to be driven directly into the bone with no need for pre-drilling. Cancellous Screw Design Deeper screw threads provide optimal engagement into the cancellous bone of the chest wall. Innovative Locking Technology Screw threads lock into the plate while the tip engages the posterior cortex of the rib. These dual points of stability are crucial for the dynamic motions of the chest wall.

RibFix Blu - Bench Testing The RibFix Blu Thoracic Fixation System was tested in plastic blocks under dynamic motion testing using ASTM F1717 as a guide and subjected to bending loads of 400Nmm 1 for 1,000,000 cycles 2. This is equivalent to 10X the normal respiratory loading and more than six weeks of fracture healing. All constructs were able to withstand the exaggerated loading without any failures. Dynamic Motion Bending Test RibFix Blu plates and screws were fixated onto plastic blocks. Side supports were then connected to the plastic blocks with hinge pins. The inferior support was attached to the load cell base plate while the superior support was rigidly attached to the hydraulic actuator. The load cell base plate remained stationary while the hydraulic actuator pushed downward creating rotation in the vertical axis. ASTM F1717 was used as a guide because the dynamic compression motion of the test simulates the motion that a rigid implant for the ribs would experience. 1 Internal Testing Report, LT1474, Fatigue testing of RibFix Blu plate and screw constructs. 2 The estimate for the amount of cycles representative of fracture healing is based on 14.1 breaths per minute. 3 Internal Testing Report, LT1476, RibFix Blu plate and screw construct in cadaver bone testing 4 Internal Testing Report, LT1477, RibFix Blu plate and screw construct in cadaver bone testing Bench testing is not indicative of clinical performance.

RibFix Blu - Biomechanical Testing Test Summary The RibFix Blu Thoracic Fixation System was tested in human cadaveric osteopenic rib bones. Fractured ribs were stabilized with the RibFix Blu Fixation System and subjected to 5X the normal respiratory loads for 360,000 cycles, simulating a two-week fracture healing period. All constructs were able to withstand the exaggerated loading without any failures. Figure 1. The intact osteopenic rib was situated in the frame for biomechanical cadaveric testing. 3 Figure 2. Compressive loads were applied to create a realistic fracture pattern within the rib. 3 Figure 3. The rib was measured, and the fracture segments were reduced and plated using the appropriate size RibFix Blu plate and appropriate length screws, ensuring a minimum of three screws were implanted on both sides of the fracture. 3 Fig. 2 Figure 4. Biomechanical testing was repeated on the fixated rib in a humid environment resembling physiologic conditions. 4 Fig. 3 Fig.1 Fig. 4

RibFix Blu - Instruments Bayoneted Plate-holding Forceps, Left 76-0001 Bayoneted Plate-holding Forceps, Right 76-0002 Rib Elevator 76-0004 Screw Sizer 76-0005 Trocar Handle 76-0012 Soft-tissue Retractor 76-0014 Non-threaded Drill Guide 76-0013 Trocar Cannula 76-0015 Scapula Drill Guide 76-0011 Items not to scale

RibFix Blu - Instruments Trocar, Long 76-0016 Threaded Plate Bender, Cannulated 76-1195 In-Situ Plate Bender 76-1196 Contra-angle Screwdriver Torque Handle 76-0008 Contra-angle Screwdriver 24-1189 2.4mm Plate-holding Wand 76-0006 Depth Gauge, 45mm Long 01-9125 Plate-holding Forceps 01-9095 Fiber Optic Cable 01-0371 Items not to scale

RibFix Blu - Instruments Plate Cutter 46-0002 Large Plate Bender 76-0003 Bone-reduction Forceps 24-1112 Drills, Blades, Drivers Power Driver Blade 73-1191 Screwdriver Blade 73-1194 Screwdriver Blade, Long 73-1196 Contra-angle Screwdriver Blade SP-2379 1.3mm Adjustable Drill Bit, Short 76-2001 1.3mm Adjustable Drill Bit, Long 76-2010 Temporary Fixation Screw 76-0007 Items not to scale

RibFix Blu - Drills, Blades, Drivers Power Driver 50-1000 Scapula Drill 76-0010 Black Ratcheting Handle 46-0008 Power Driver Battery 50-1010 2.4mm/2.7mm Screws Self-Drilling Locking Screws (Green) Self-Tapping Screws (Silver) Rescue Screws (Purple) Part No. Description Part No. Description Part No. Description 76-2407 2.4 x 7mm 76-2507 2.4 x 7mm 76-2707 2.7 x 7mm 76-2408 2.4 x 8mm 76-2508 2.4 x 8mm 76-2708 2.7 x 8mm 76-2410 2.4 x 10mm 76-2510 2.4 x 10mm 76-2710 2.7 x 10mm 76-2412 2.4 x 12mm 76-2512 2.4 x 12mm 76-2712 2.7 x 12mm 76-2414 2.4 x 14mm 76-2514 2.4 x 14mm 76-2714 2.7 x 14mm 76-2416 2.4 x 16mm 76-2516 2.4 x 16mm 76-2716 2.7 x 16mm Items not to scale

RibFix Blu - Implants Plates Templates 8- Hole Straight Plate 76-2601 8-Hole Plate Template 76-9101 12-Hole Pre-Contoured Plate 76-2602 12-Hole Plate Template 76-9102 16-Hole Pre-Contoured Plate 76-2603 16-Hole Plate Template 76-9103 24-Hole Pre-Contoured Plate 76-2604 24-Hole Plate Template 76-9104 Items not to scale

76-2601 76-2602 76-2603 76-2604 76-9101 73-1194 76-2601 76-2602 76-2603 76-2604 76-2601 76-2602 76-2603 76-2604 76-2601 76-2602 76-2603 76-2604 Self-Drilling 76-24XX Self-Drilling 76-24XX Self-Drilling 76-24XX Self-Drilling Self-Drilling 76-24XX 76-24XX 76-24XX Self-Tapping 76-25XX Self-Tapping 76-25XX Self-Tapping 76-25XX Self-Tapping Self-Tapping 76-25XX 76-25XX 76-25XX Emergency 76-27XX Emergency 76-27XX Emergency Emergency 76-27XX 76-27XX 7 7 8 8 8 10 10 10 10 10 12 12 12 12 12 14 14 14 14 14 16 16 76-9101 76-9102 76-9102 76-9103 76-9103 76-9104 76-9104 73-1194 73-1194 73-1194 76-0007 76-0007 76-0007 76-0007 SP-2379 SP-2379 SP-2379 SP-2379 73-1196 73-1196 73-1196 73-1196 RibFix Blu - Tray Components Containers and Tray Components Outer Container Base 76-5006-02 Screw Caddy* 76-5003 Implant Caddy* 76-5001 Instrument Tray Insert 76-5007 Mat, Short 76-5011 Mat, Long 76-5012 Complete Tray 76-5006 Container Lid 76-5006-01 Power Driver Tray 76-5009 (tray only) Tray ID Set 76-5010 *Caddies only. No Implants or screws included Items not to scale

RibFix Blu For more information on RibFix Blu and other thoracic fixation solutions, please contact us at: BIOMET MICROFIXATION GLOBAL HEADQUARTERS 1520 Tradeport Drive Jacksonville, FL 32218-2480 Tel 904.741.4400 Toll-Free 800.874.7711 Fax 904.741.4500 Order Fax 904.741.3059 www.zimmerbiomet.com EUROPE Toermalijnring 600 3316 LC Dordrecht The Netherlands Tel +31 78 629 29 10 Fax +31 78 629 29 12 All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to Zimmer Biomet Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet. This material is intended for healthcare professionals and the Zimmer Biomet sales force. Distribution to any other recipient is prohibited. Zimmer Biomet does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and products for each individual patient. For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert or visit our website at www.zimmerbiomet.com. 2015 Zimmer Biomet www.zimmerbiomet.com Form No. BMF00-7430 Rev 03k1508