® UNIFLEX Nailing System NIFLEXIBILITY Titanium Alloy Construction Compared to stainless steel, titanium alloy provides added strength for internal fixation of shaft fractures with a lower modulus of elasticity. The resultant flexibility aids in the insertion of the nail and results in increased load transfer to the bone to stimulate fracture healing. Convenient, Sterile Packaging Implants are packaged pre-sterile for convenience and assured sterility in the operating room. Simplified Nail Removal The end cap threads into the proximal end of the nail, reducing the possibility of fibrous tissue growth into the threads. Upon removal of the end cap, threads are clear, facilitating extraction. Faster Insertion with Pathfinder™ Tips The tapered design of the Pathfinder Tip aids passage down the intramedullary canal and across the fracture site, while reducing the risk of cortical impingement. Simple, Accurate Instrumentation Precise reproducible instruments thread easily into the nails, providing exceptional control and rotational stability during insertion and extraction. One thread size for all nails simplifies instrumentation. Instruments are well organized in a single sterilization case for convenience. Surgical Latitude The Uniflex Family of Intramedullary Nails can be utilized in a reamed or nonreamed mode, based on surgeon preference and individual patient requirements. For Your Most Demanding Cases Titanium alloy provides a unique blend of strength and flexibility, ideal for intramedullary fixation. The yield strength of titanium alloy is twice that of stainless steel and its ultimate tensile strength is almost 25% higher. In addition, the combined mechanical properties of high strength and a lower modulus of elasticity allow the Uniflex Nail to potentially offer reduced implant failure and improved stimulation of fracture healing. 1 roven Küntscher concept of a full longitudinal slot promotes healing by allowing micromotion at the fracture site. The longitudinal slot compresses during insertion making the nail more “forgiving” and requiring overreaming of only 1-1.5mm. ■ The yield strength of titanium alloy is twice that of stainless steel and its ultimate tensile strength is almost 25% higher. ■ Two proximal reconstructive screw holes are placed at a 125o neck/shaft angle and anteverted left and right 9o to accommodate the anteversion of the femoral neck. Distal screw holes are positioned to capture fragments close to the femoral condyles. ■ Much stronger than stainless steel, self-tapping titanium screws allow for easy insertion and increased strength and are available in 9 lengths. ■ Uniflex Nails are left and right bowed and are available in diameters from 10mm to 16mm and lengths from 32cm to 48cm. Case Data Pre-op X-ray of a male who sustained a combination fracture of the femoral neck and shaft in a motorcycle accident. 11 months post-op X-ray showing the Uniflex Nail in reconstructive fixation with fracture healing and no signs of avascular necrosis. Uniflex Femoral Nail 2 Preoperative Postoperative Reamed or Unreamed, the Uniflex Nail addresses a wide range of femoral fractures with one system. Standard Intramedullary Indications: • Noncomminuted midshaft fractures (A) Interlocking Indications • Comminuted shaft fractures (B) • Subtrochanteric fractures (C) • Distal third fractures (D) Reconstructive Indications: • Combination fractures of the shaft and neck (E) • Intertrochanteric fractures (F) A B C D E F G • Combined intertrochanteric and subtrochanteric fractures (G) • Reconstruction following tumor resection Simple, Accurate Instrumentation Instruments thread easily into the nails providing exceptional control and rotational stability during insertion and extraction. One thread size for all nails simplifies instrumentation. Instruments are well organized in a single sterilization case for convenience. The Uniflex® Femoral Nail System was developed in cooperation with the Biomechanics Research Laboratory of Orthopaedic Hospital/USC and the Department of Orthopaedics, University of Southern California School of Medicine. 3 uch stronger than stainless steel in yield strength, and 25% higher in ultimate tensile strength, selftapping titanium screws allow for easy insertion, increased strength, and are available in 10 lengths. ■ In addition, the combined mechanical properties of high strength and a lower modulus of elasticity allow the Uniflex Nail to offer a potential reduction of implant failure and improved stimulation of fracture healing. ■ Distal screw holes are positioned to capture fragments close to the femoral condyles. ■ Uniflex Tibial Nails are available in lengths from 24cm to 38cm in the 8mm and 9mm diameter nails and 24cm to 42cm in the 10mm through 14mm diameter nails. Uniflex Tibial Nail 4 Case Data Age/Sex: 29/Male Injury: Motor vehicle accident Fracture: Distal oblique Fixation: Static locked nail Date of Surgery: 1-6-91 Preoperative Postoperative Simple, Accurate Instrumentation Instruments thread easily into the nails providing exceptional control and rotational stability during insertion and extraction. One thread size for all nails simplifies instrumentation. Instruments are well organized in a single sterilization case for convenience. The Uniflex® Tibial Nail System was developed in cooperation with the Biomechanics Research Laboratory of Orthopaedic Hospital/USC and the Department of Orthopaedics, University of Southern California School of Medicine. 5 umeral nails of titanium alloy provide a unique blend of strength and flexibility. ■ Ideally suited for intramedullary fixation, the yield strength of titanium alloy is twice that of stainless steel and its ultimate tensile strength is almost 25% higher. ■ In addition, the combined mechanical properties of high strength and a lower modulus of elasticity allow the Uniflex Nail to offer a potential reduction of implant failure and improved stimulation of fracture healing. ■ Self-tapping titanium screws allow for easy insertion and increased strength, and are available in 6 lengths. Uniflex Humeral Nails are available in diameters of 8mm and 9mm and lengths of 18cm to 28cm. Case Data Open segmental humerus fracture associated with multiple blunt trauma. Uniflex Humeral Nail 6 Preoperative Postoperative Indications Most fractures of the humerus will heal in a satisfactory fashion without operation. However, the Uniflex Humeral Nail System has been designed to treat certain difficult humeral fractures in which noninvasive treatments have historically failed to give predictable results. Nonunion Malunion Metastatic Disease Mulitple Trauma w/ Head Injury Pathological Fracture Simple, Accurate Instrumentation Although proximally attached distal alignment guides for locking distal screws have not generally performed well in the femur, the humerus is shorter and lighter and is exposed to milder intraoperative stresses, allowing use of the distal target guide. This greatly simplifies the need for intraoperative imaging. Instruments thread easily into the nails providing exceptional control and rotational stability during insertion and extraction. One thread size for all nails simplifies instrumentation. Instruments are well organized in a single sterilization case for convenience. The Uniflex® Humeral Nail System was developed in conjunction with Ralph B. Blasier, M.D., Chief of Orthopaedics, Grace Hospital, Detroit, MI. 7 Nailing System Ordering Information NOTE: When implanting a 10mm-13mm Uniflex Femoral Nail, it is extremely important to ream the entry portal to 14mm in diameter to a depth of approximately 3" (8 cm) below the entry portal. Right Reconstructive Grooves in titanium screw heads distinguish them from stainless steel screws. Uniflex® Titanium Nail Right Interlocking Left Reconstructive Part Number Length 32cm 34cm 36cm 38cm 40cm 42cm 44cm 46cm 48cm 10mm Diameter 11mm Diameter 12mm Diameter 13mm Diameter 14mm Diameter 15mm Diameter 16mm Diameter 341232 341234 341236 341238 341240 341242 341244 341246 341248 341332 341334 341336 341338 341340 341342 341344 341346 341348 341432 341434 341436 341438 341440 341442 341444 341446 341448 341532 341534 341536 341538 341540 341542 341544 341546 341548 341632 341634 341636 341638 341640 341642 341644 341646 341648 341732 341734 341736 341738 341740 341742 341744 341746 341748 341832 341834 341836 341838 341840 341842 341844 341846 341848 5mm diameter screws are used only for the distal holes in the 10mm and 11mm diameter nails. Primary set Uniflex® Titanium Nail Left Interlocking Right Reconstructive Part Number Length 32cm 34cm 36cm 38cm 40cm 42cm 44cm 46cm 48cm 10mm Diameter 11mm Diameter 12mm Diameter 13mm Diameter 14mm Diameter 15mm Diameter 16mm Diameter 342732 342734 342736 342738 342740 342742 342744 342746 342748 342832 342834 342836 342838 342840 342842 342844 342846 342848 342932 342934 342936 342938 342940 342942 342944 342946 342948 343032 343034 343036 343038 343040 343042 343044 343046 343048 343132 343134 343136 343138 343140 343142 343144 343146 343148 343232 343234 343236 343238 343240 343242 343244 343246 343248 343332 343334 343336 343338 343340 343342 343344 343346 343348 5mm diameter screws are used only for the distal holes in the 10mm and 11mm diameter nails. 8 Titanium Low Profile End Cap 345211 Left Interlocking Titanium Screw Buttress Thread Titanium Screw Buttress Thread 5mm Diameter*/ Fully Threaded 6mm Diameter*/ Fully Threaded Note: All Note: All proximal proximal holes use holes use the 5mm the 5mm diameter diameter screws screws Use Twist Use Twist Drill 4.3mm Drill 4.3mm Diameter Diameter Part Number 33-345420 33-345422 33-345424 33-345426 33-345428 33-345430 33-345432 33-345434 33-345436 33-345438 33-345440 33-345442 33-345444 33-345446 33-345448 33-345450 33-345452 33-345454 Part Number Length –– 25mm 33-345520 30mm 33-345522 35mm 33-345524 40mm 33-345526 45mm 33-345528 50mm 33-345530 55mm 33-345532 60mm 33-345534 65mm 33-345536 70mm 33-345538 75mm 33-345540 80mm 33-345542 85mm 33-345544 90mm 33-345546 95mm 33-345548 100mm –– 105mm –– 110mm (*5mm diameter screws are used only for distal holes in the 10mm and11mm diameter nails) Titanium Fixation Screws 6.3mm Diameter / Partially Threaded Reconstructive Only Part Number Length 345620 345622 345624 345626 345628 345630 345632 345634 345636 345638 345640 70mm 75mm 80mm 85mm 90mm 95mm 100mm 105mm 110mm 115mm 120mm nstrumentation Driver with Handle 471720 (Patent No. 4,911,153) Driver Bolt 471722 HIGH CLEARANCE ONLY: High Clearance Driver w/ Handle 471710 Driver Bushing 471723 High Clearance Driver Bolt 471712 Offset Driver 471730 High Clearance Offset Driver 471714 Plain Bar 471731 High Clearance Proximal Target 471716 Universal Hex Socket Wrench 471756 19mm(3⁄4") INTERLOCKING ONLY: Titanium End Wrench 471758 19mm(3⁄4") Guide Tube A 471732 Hex Drive T-Wrench 471760 5mm x 280mm Trocar for Guide Tube A 471733 Hex Drive Power Bit 471761 5mm Drill Bushing A 471734 5mm Nail Extractor w/ Slide Hammer 471764 Calibrated Drill (Sterile) 471736 5mm x 254mm Nail Extractor Adaptor 471768 RECONSTRUCTIVE ONLY: Nail Extractor Hook w/ Adaptor 471770 8mm Medullary Alignment Tube - Pkg./6 469388 with ring 469392 without ring Screw Depth Gauge 34-513646 FOR 10MM AND 11MM NAILS (DISTAL HOLES ONLY): Twist Drill (Sterile) 472255 4.3mm x 180mm Hex Drive T-Wrench 457118 3.5mm Radiolucent Distal Targeting Device 471860 Device 471872 4.3mm drill bit for 10mm and 11mm nail 471878 5.0mm drill bit Distal Targeting Awl 471794 4.3mm for 10mm and 11mm nail 471795 5.0mm For Freehand Distal Targeting Depth Gauge for Crowe Point Twist Drill 472080 4.3mm Crowe Point Twist Drill (Sterile) 472068 5.0mm Crowe Point Twist Drill (Sterile) 472074 Guide Pin 27-361681 3.2mm x 305mm (1⁄8" x 12") Pkg./6 25-361681 3.2mm x 305mm (1⁄8" x 12") Pkg./5 (Sterile) Templates 471750 Proximal Target for Standard Driver 471740 SUGGESTED ADDITIONAL INSTRUMENTATION Nail Driving Guide (2 ea.) 467220 4.4mm x 80cm Guide Tube B - (Req. 2 ea.) 471742 Reduction Lever 469385 Trocar Guide Tube B 471743 Instrument Case 592024 Case 1 592025 Case 2 Drill Bushing B - (Req. 2 ea.) 471744 6.2mm Guide Bushing B - (Req. 2 ea.) 471746 3.2mm Calibrated Step Drill (Sterile) 471748 6.2mm x 330mm Video Y-BVP-067V Skin Protector 476920 X-ray Scale 475920 9mm T-handle Reamer 468138 Guide Pin Hand Grip 469675 469685 Replacement Collet 9 Nailing System Ordering Information Uniflex® Titanium Tibial Nails Part Number Length 8mm Diameter 9mm Diameter 10mm Diameter 11mm Diameter 12mm Diameter 13mm Diameter 14mm Diameter 24cm 33-344024 33-344124 33-344224 33-344324 33-344424 33-344524 33-344624 26cm 28cm 30cm 32cm 34cm 36cm 38cm 40cm 42cm 33-344026 33-344028 33-344030 33-344032 33-344034 33-344036 33-344038 –– –– 33-344126 33-344128 33-344130 33-344132 33-344134 33-344136 33-344138 –– –– 33-344226 33-344228 33-344230 33-344232 33-344234 33-344236 33-344238 33-344240 33-344242 33-344326 33-344328 33-344330 33-344332 33-344334 33-344336 33-344338 33-344340 33-344342 33-344426 33-344428 33-344430 33-344432 33-344434 33-344436 33-344438 33-344440 33-344442 33-344526 33-344528 33-344530 33-344532 33-344534 33-344536 33-344538 33-344540 33-344542 33-344626 33-344628 33-344630 33-344632 33-344634 33-344636 33-344638 33-344640 33-344642 4mm diameter screws are used only for the distal screw holes in the 8mm and 9mm diameter nails. 5mm diameter screws are used for the distal screw holes in the 10mm through 14mm diameter nails. Titanium Fixation Screws Titanium End Cap 345215 10 Primary set Titanium Screw Buttress Thread 4mm Diameter / Fully Threaded 5mm Diameter / Fully Threaded (4mm diameter screws are used only for distal holes in the 8mm and 9mm diameter nails) Note: All proximal holes use the 5mm diameter screws Use Twist Drill 4.3mm Diameter Part Number Length Part Number Length 345264 345266 345268 345270 345272 345274 345276 345278 345280 345282 345284 345286 345288 345290 345292 345294 345296 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 42mm 44mm 46mm 50mm 54mm 58mm 33-345418 33-345420 33-345422 33-345424 33-345426 33-345428 33-345430 33-345432 33-345434 33-345436 33-345438 33-345440 33-345442 33-345444 33-345446 33-345448 33-345450 33-345452 33-345454 20mm 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm 65mm 70mm 75mm 80mm 85mm 90mm 95mm 100mm 105mm 110mm nstrumentation Driver Bushing 471615 3.5mm Hex Drive T-Wrench 457118 SUGGESTED ADDITIONAL INSTRUMENTATION Driver Bolt 471525 T-Wrench 3⁄8" Hex 449110 Skin Protector 476920 Target Arm 471630 Nail Driving Guide 3.2mm x 80cm (2 ea.) 467210 Reduction Lever 469385 Driver Handle (Threaded) 471535 Depth Gauge 34-513644 Driver Handle (Plain) 471635 Nail Extractor Adaptor 471560 Proximal Target 471640 Slide Hammer 471565 Guide Tube (2 ea.) 471545 Instrument Case 592136 Trocar for Guide Tube 471546 6.3mm Medullary Alignment Tube (for use w/8-9mm nails) Pkg./6 (Sterile) 469394 with ring Drill Bushing 4.3mm (2 ea.) 471650 Calibrated Twist Drill 4.3mm x 203mm (Sterile) 471655 Twist Drill 3.6 x 180mm (Sterile) 472366 3.6 x 180mm (Sterile) 472368 3.2 x 180mm (Sterile) Cortical Step Drill 5 ⁄16" (8mm) x 1⁄2" (12.7mm) Dia. 464530 8mm Medullary Alignment Tube (for use w/10-14mm nails) Pkg./6 (Sterile) 469388 with ring 469392 without ring Radiolucent Distal Targeting Device (Sterile) 471860 X-ray Scale 475920 Diamond Point Tibial Awl 470320 Guide Pin Hand Grip 469675 469685 Replacement Collet Distal Target Awl 471793 3.6mm 471794 4.3mm For Freehand Distal Targeting Depth Gauge for Crowe Point Twist Drill 472080 3.6mm Crowe Point Twist Drill (Sterile) 472064 4.3mm Crowe Point Twist Drill (Sterile) 472068 Crowe Point Snap On Twist Drill (Sterile) 471868 3.6mm 471872 4.3mm 471864 3.2mm Template 471605 Video Y-BVP-055V 11 Uniflex® Titanium Humeral Nail Titanium Fixaton Screws 4.5mm Diameter / Fully Threaded Part Number Length Nailing System Ordering Information 8mm Diameter 9mm Diameter 18cm 340618 340718 20cm 22cm 24cm 26cm 28cm 340620 340622 340624 340626 340628 340720 340722 340724 340726 340728 Part Number Length 345316 345318 345320 345322 345324 345326 345328 345330 345332 345334 345336 345338 345340 345342 345344 345346 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 42mm 44mm 46mm NOTE: 7mm, 10mm and 11mm diameter nails in lengths of 18cm to 28cm are available on request. Titanium End Cap 345220 nstrumentation Driver Bushing 471620 T-Wrench 3/8" Hex Socket 449110 Driver Bolt 471525 Screw Depth Gauge 34-513644 Target Arm 471530 Twist Drill (Sterile) 472366 3.6mm x 180mm Driver Handle 471535 Proximal Target 471540 Guide Tube (2 ea.) 471545 Drill Bushing 3.6mm (2 ea.) 471550 Distal Target 471555 3.5mm Hex Drive T-Wrench 457118 12 Nail Extractor Adaptor 471560 Slide Hammer 471565 Nail Driving Guide 3.2mm x 48cm (2 ea.) 467212 6.3mm Medullary Alignment Tube w/ Ring (Sterile) 469394 Pkg./6 1/4" Step Drill 466365 Instrument Case 592137 SUGGESTED ADDITIONAL INSTRUMENTATION Guide Pin Handgrip 469675 469685 Replacement Collet Drill Bushing Ex-Long 3.6mm (2 ea.) 471552 Guide Tube Ex-Long (2 ea.) 471547 Trocar for Guide Tube 471546 X-Ray Scale 475920 Template 471505 Video Y-BVP-056V odular Flexible Reamer System™ Features • The Küntscher style head design has proven to provide better venting than many competitive reamer heads.1,2 • Reversible shaft design provides easier removal intraoperatively. • One shaft diameter (8mm) for use with all reamer head diameters (8mm-20mm). • A simple more convenient system that saves time. • Extra long shaft length (52cm) allows greater distal reaming when necessary. Reamer Heads 467734 8.0mm 467736 8.5mm 467738 9.0mm 467740 9.5mm 467742 10.0mm 467744 10.5mm 467746 11.0mm 467748 11.5mm 467750 12.0mm 467752 12.5mm 467754 13.0mm 467756 13.5mm 467758 14.0mm 467760 14.5mm 467762 14.0mm 467764 15.5mm 467766 16.0mm 467768 16.5mm 467770 17.0mm 467772 17.5mm 467774 18.0mm 467776 18.5mm 467778 19.0mm 467780 19.5mm 467782 20.0mm Ti-Nit Reamer Heads 467634 8.0mm 467636 8.5mm 467638 9.0mm 467640 9.5mm 467642 10.0mm 467644 10.5mm 467646 11.0mm 467648 11.5mm 467650 12.0mm 467652 12.5mm 467654 13.0mm 467656 13.5mm 467658 14.0mm 467660 14.5mm 467662 14.0mm 467664 15.5mm 467666 16.0mm 467668 16.5mm 467670 17.0mm 467672 17.5mm 467674 18.0mm 467676 18.5mm 467678 19.0mm 467680 19.5mm 467682 20.0mm Reamer Shafts 467716 8.0mm Dia. 40cm Length 469685 8.0mm Dia. 52cm Length Sterilization Case 593241 Reamer Accessories 469060 3.2mm x 98cm Ball Tip Guide Wire 476920 Skin Protector 1. Winquist, R.A., Bogosian, A.J., Relationship of Intramedullary Reamer Design to Intramedullary Pressure and Fat Embolism. Presented at the 61st Annual AAOS, Paper No. 160, 1994. 2. Pape H-C. “Does the Reamer Type Influence the Degree of Lung Dysfunction After Femoral Nailing Following a Severe Trauma?”, An Animal Study, Journal of Orthopaedic Trauma, 1994; 8(4): 300-309. Biomet, Inc. Warsaw, IN 46580 (219) 267-6639 ©1998 Biomet, Inc. All Rights Reserved Biomet Ltd., Waterton Industrial Estate, Bridgend, South Glamorgan CF31 3YN, U.K. Form No. Y-BMT-451R/093098/H
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