EXTERNAL FIXATION SYSTEM

EXTERNAL FIXATION SYSTEM

The Apex Pin Fixation System is a one step procedure reducing insertion time and reducing insertion temperature. There are three types of fixation pins: Self-drilling / Self-tapping Apex Pins The unique One Step Cutting Technology offers significant advantages over traditional pins. Apex Pins always act as a new drill, so there is no need to pre-drill Their One Step Insertion and high cutting performance leads to reduced operative time. Reduced insertion temperatures due to reduced friction. Blunt Apex Pins Designed with a smooth non-cutting tip for use in hard cortical bone or for use in zones where a previous fracture may have occurred. Blunt Apex Pins are based on the same technology as One Step Pins, however due to their lack of a drill tip, Blunt Apex Pins require pre-drilling. Blunt Apex Pins should be used when better protection of soft tissues is required. Intended for use in the pelvis. Transfixing Apex Pins Designed for use in double frames requiring a high degree of stability. 2

Cancellous Apex Pins Designed for use in metaphyseal / epiphyseal areas i.e. in cancellous areas to ensure a higher pin stability and therefore a higher frame stability. Note that Cancellous Apex Pins require pre-drilling. Titanium Apex Pins Titanium Apex Pins offer the same One Step Cutting Technology as the self drilling / self tapping pins i.e.: Titanium Apex Pins always act as a new drill, so there is no need to pre-drill One Step Insertion and high cutting performance leads to reduced operative time Reduced insertion temperatures due to reduced friction Titanium alloy Ti6Al-4V offers an excellent biocompatibility and is particularly recommended for patients Requiring MRI or CT scans since titanium alloy reduces image distortions Allergic to nickel contained in Stainless Steel Titanium alloy Ti6Al-4V has been chosen for titanium Apex Pins due to Its hardness which is equivalent to 316L Stainless Steel (37 HRC) and superior to pure titanium (17 HRC) whose pin tip may be damaged during insertion Its greater resistance to fatigue than pure titanium 3

Cutting Technology The Apex Pin Fixation System uses an advanced cylindrical thread profile that is designed to improve anchorage and pull-out resistance. Apex One Step Pins have a tip design, that provides optimal cutting conditions during the drilling phase. A U-shaped thread increases contact with the bone by over 30% and optimises the stress distribution in the bone by reducing radial cortical tension. A unique double helical flute creates homogenous thread profiles and evacuates bone chips to the rear. These design features have significantly reduced insertion time and temperature, and have improved anchorage conditions. The axial force and the torque required to insert the pins have also been significantly reduced. U-shaped thread Self-tapping section Self-drilling tip 4

Advanced Cutting Tip Designed to: Act as a drill bit and a screw simultaneously. Allow an accurate drilling of the second cortex. Minimise cortical protrusion due to a shorter tip point which reduces soft tissue damage. Reduce insertion moments due to improved cutting parameters. Reduce insertion temperature to below 50 C. Reduce operative time due to their one step procedure. Improve the cutting of the thread due to a better evacuation of bone chips through a unique double helical flute. Reduce risk of cortical damage due to uniform stress distribution. 50 C Advanced Thread Profile Positive cutting angle improves cortical contact Designed to: Provide improved anchorage Improve frame stability Reduce risk of infection Improve fatigue and pull out resistance 5

Cutting Technology Summary The advanced cutting technology combined with the advanced design of the tip of the pin allows high cutting performances with an optimal bone debris removal. This combination provides a positive influence on the following parameters which are of vital importance for pin stability: Lower insertion forces Lower friction between bone and metal during pin insertion Lower insertion temperature Lower rate of bone necrosis Higher pin stability Pin stability is vital to the success of external fixation because, whatever the external fixation components and whatever the frame constructions, if the pin stability is not good a stable frame construction cannot be reached. Competitive Design Conical Design Looks OK in Theory, But Need for pre-drilling means two step insertion procedure. High pressure on bone during insertion and increased risk of thermal necrosis during the pre-drilling phase. Risk of loosening due to the conical design. Conical design may lead to loosening Impossible to back-up the pin if the tip protrudes too far. Radial compression may lead to cortical damage 6

Pin Characteristics In external fixation the global stiffness, stability and elasticity of frames is strongly influenced by the configuration i.e. the number of rods, pin placement, pin diameter and the number of pins. Pin Placement A bigger distance between pins induces a higher frame stability i.e. it is recommended to place the pins in the extreme holes of the clamps when it is possible. Pin Diameter The choice of pin diameter should be determined by taking into account all the following parameters: Stability Anatomical location Rigidity / elasticity Size of bone Soft tissues Pin Biomechanics The effect of pin diameter on axial frame stiffness. N/m 10-3 2 000 When comparing axial frame stiffness a 1mm increase in pin diameter will approximately double frame stiffness. However, as a general rule, we can consider that: Minimum pin shaft diameter = Cortical bone thickness / 2 364.8 860.0 5 mm 1,675.4 6 mm 2 000 2 000 2 000 Number of Pins The number of pins is dependent on 4 mm 2 000 Efforts on the frame (lengthening) The frame stiffness to be reached By adding pins, the frame stiffness will be increased. Instrumentation Drill sleeves are imperative in order to protect soft tissues. Don t tap the trocar. Turn anticlockwise for a few turns to create an insertion point and then proceed clockwise. Drill sleeves can be utilised together with the clamps or with the insertion guide. Use Stryker Trauma Drill Brace!! Apex Pins have an integrated safety feature to reduce potential breakage of the pin tip. Apex Pins must be used with a Stryker Trauma drill brace to effect this feature. Increased drilling sensitivity. Better feeling of the second cortex. Integrated safety feature reduces potential tip breakage under high insertion forces 7

Compatibility between the Apex Pins and the Stryker Trauma External Fixation Systems Stryker Trauma Components Hoffmann II pin to rod coupling (4920-1-020) Stryker Trauma Apex Pin Shaft Diameters Hoffmann II pin clamp (4920-2-020) Hoffmann II Compact pin to rod coupling (4940-1-020) Ø 6mm Ø 3mm Hoffmann II Compact clamp (4940-2-020) Ø 3mm Hoffmann II Compact peri-articular clamp (4940-2-200) Ø 3mm Triax pin clamp red (5150-3-075) Ø 6mm Triax pin clamp blue (5150-3-070) Triax pin clamp yellow (5150-3-065) Ø 3mm Triax single pin clamp red (5150-3-175) Ø 6mm Triax single pin clamp blue (5150-3-170) Triax single pin clamp yellow (5150-3-165) Ø 3mm Tenxor pin post (4936-2-030) Ø 6mm 8

Apex Pins Range Dimensions (mm) Cat No. Shaft & Thread Total Thread Cat No. Diameter Length Length Products Self Drilling/Self Tapping 5038-5-060 3 60 10 5038-1-080 3 80 10 5038-2-080 3 80 15 5038-5-080 3 80 20 5038-1-110 3 110 10 5038-2-110 3 110 25 5023-1-090 4 90 10 5023-2-090 4 90 20 5023-3-090 4 90 30 5023-3-120 4 120 30 5023-5-120 4 120 35 5023-5-150 4 150 40 5023-6-150 4 150 50 5023-4-180 4 180 40 5023-6-180 4 180 50 TITANIUM 5018-3-120 5 120 30 5018-5-120 5 120 35 5016-5-111 5018-5-150 5 150 40 5016-5-117 5018-6-150 5 150 50 5016-5-118 5018-6-180 5 180 50 5016-5-122 5018-8-180 5 180 60 5018-5-200 5 200 50 5018-6-200 5 200 60 5018-5-250 5 250 50 5018-7-250 5 250 70 5021-7-150 6 150 50 5021-6-180 6 180 60 5021-8-200 6 200 70 5021-8-250 6 250 80 Blunt 5036-2-060 3 60 10 5036-1-080 3 80 10 5036-1-580 3 80 15 5036-2-080 3 80 20 5036-1-110 3 110 10 5036-2-110 3 110 25 5027-1-090 4 90 10 5027-2-090 4 90 20 5027-3-090 4 90 30 5027-3-120 4 120 30 5027-4-120 4 120 35 5027-4-150 4 150 40 5027-5-150 4 150 50 5027-4-180 4 180 40 5027-5-180 4 180 50 9

Apex Pins Range Dimensions (mm) Cat No. Shaft & Thread Total Thread Diameter Length Length Blunt continuation 5020-3-120 5 120 30 5020-6-120 5 120 35 5020-3-150 5 150 40 5020-7-150 5 150 50 5020-7-180 5 180 50 5020-8-180 5 180 60 5020-7-200 5 200 50 5020-6-200 5 200 60 5020-7-250 5 250 50 5020-8-250 5 250 70 5019-7-150 6 150 50 5019-6-180 6 180 60 5019-8-200 6 200 70 5019-8-250 6 250 80 Dimensions (mm) Cat No. Shaft Thread Total Thread Diameter Diameter Length Length Products Cancellous 5015-3-120 5 6 120 35 5015-4-150 5 6 150 40 5015-5-150 5 6 150 50 5015-6-180 5 6 180 60 5015-7-250 5 6 250 70 Transfixing 5030-3-200 4 5 200 35 5030-4-200 4 5 200 40 5030-5-200 4 5 200 50 5030-3-250 4 5 250 35 5030-4-250 4 5 250 40 5030-5-250 4 5 250 50 5030-6-250 4 5 250 60 5030-4-300 4 5 300 40 5030-5-300 4 5 300 50 5030-7-300 4 5 300 70 10

Instruments Catalogue Number Description 5057-0-100 Apex Drill Guide Assembly 5057-0-200 Drill Brace Assembly for 3mm/4mm/5mm/6mm Apex Pins 5057-3-100 3mm Predrilling Assembly-Short 5057-3-200 3mm Predrilling Assembly-Long 5057-4-100 4mm Predrilling Assembly-Short 5057-4-200 4mm Predrilling Assembly-Long 5057-5-100 5mm Predrilling Assembly-Short 5057-5-200 5mm Predrilling Assembly-Long 5057-6-100 6mm Predrilling Assembly-Short 5057-6-200 6mm Predrilling Assembly-Long 5085-1-222 Drill 2.2mm for 3mm pins 5085-2-032 Drill 3.2mm for 4mm pins 5085-2-040 Drill 4.0mm for 5mm pins 5085-2-045 Drill 4.5mm for 6mm pins 5057-9-900 Apex Pins and Instrumentation Storage and Sterilisation Tray Stryker, Hoffmann II, Monotube, Apex, Tenxor, Compact and Triax are trademarks of Stryker Corporation. Hoffmann II Swiss Patent Application: 01-709/94-3. Other Patents Pending. * Patents: EU 385,929; 374,093; Canada 1,193,506; U.S. 5,160,335 and 5,207,676. ** Swiss Patent Application: 02-709/94-3. Other Patents Pending. *** Patents: EU 190,990; U.S. 4,784,125; 5,095,919. **** Patents: EU 230,856; Swiss CH 671,150; U.S. 4,978,350. Data on file at Stryker Howmedica Osteonics USA. 11

Unilateral frame system designed to handle a wide variety of fractures and limb-lengthening applications. This simple, colour-coded system offers both dynamic and carbon tubes for individualised performance and economy. True simplicity, versatility, and economy. ** Modular frames which allow for true independent pin placement. Completely compatible with Original Hoffmann components, this new system improves flexibility and ease-of-use, while enhancing frame economics through minimal componentry. It s external fixation with a snap. * Designed to complement the anatomy of the distal radius by allowing independent movement of its clamps in multiple planes. Standard unilateral or bi-lateral bridging frames for intra-articular fractures and peri-articular non-bridging frames for extraarticular fractures. Fully compatible with the Hoffmann II System, based on a spring-loaded snap-fit mechanism that improves flexibility and ease-of-use. The DJD II is a Dynamic Elbow Joint Distractor. Fully compatible with the Hoffmann II Compact System, it is designed to treat posttraumatic elbow stiffness as well as acute elbow trauma fractures. The Tenxor System is a hybrid system providing advanced technology and ease of application. Fully compatible with Hoffmann II and Monotube Triax, based on a spring-loaded, snap-fit mechanism that improves flexibility and ease of use. **** Every Fixator incorporates the high quality pin-to-bone interface provided by Apex Pins. The Apex Pin cuts more sharply with less torque, friction and heat upon insertion improving purchase while minimising the risk of pin tract problems. Available in self-drilling and blunt tip designs, only from Stryker Howmedica Osteonics! MANUFACTURER: Manufacturing location 5 chemin des Aulx CH-1228 Plan-les-Ouates Geneva, Switzerland Tel: 00 41 22 884 0111 Fax:00 41 22 884 0199 Cat No: 5075-4-000 2001 Stryker Corporation. All rights reserved. 1101