SPS Basic Fragment Set

1 SPSB asic Fragment Set Features and Benefits Indications Operative Technique Ordering Information2 The newly developed Basic Fragment Set is designed for the most commonindications of traumatology and orthopaedics. The shape, material properties and the surface quality of the plates take into account the current demands fromclinical physicians for high fatigue strength, optimised transfer of loading forcesand a simple and standardised operative technique with broad implants are available in either Stainless Steel (316 LVM ) or Titanium Alloy( Ti-6Al-4V).Implant RationaleThe Stryker Plating System (SPS) Basic Fragment Set consists of sevendifferent plate designs. The plates aredifferentiated by their main functions are: Compression Neutralisation Buttressing Bridging CompressionThe use of individual Lag Screws intransverse and short oblique fracturesmay provide limited compression compression can therefore beincreased by using a compression platein the compression mode in accordancewith the tension band principle,whenever possible.

2 In order to provideincreased stability, an interfragmentaryscrew may be inserted through the situations where Lag Screws alonecannot provide sufficient stability,plates are used to increase stability and load sharing. When used, suchneutralisation plates protect the inter-fragmental compression achievedby the Lag Screws, from torsion,bending and shearing allows early mobilisation andcertain limited weight type of plate and screws used depends on the fracture site,pattern and the bone Lag Screw of either can also be inserted throughneutralisation specially designed plates are usedin the metaphyseal area of bone andhave the function as buttress screws must be inserted in such a position that under load there mustbe no shift in the position of the position is secured by placing thescrews in the side of the plate holeclosest to the fracture. During loadapplication, any tendency for the plateto shift is reduced by the order to maintain length andalignment, a plate can be used tobridge a badly comminuted segment of bone.

3 This type of fixation isnaturally less stable and union will depend on bridging may be given to sub-cutaneous plate applicationwhich may maintain all soft tissueattachments and the nutrification of the intervening comminutedfragments. Both plate ends have to be solidly fixed to their correspondingparts of the bone by sufficient , bridging osteosynthesis is carried out in combination withbone grafting. Tumour resections and bone elongations represent othersituations where bridging plates areused. The compression plate of theStryker Basic Fragment Set can be used as a bridging plate in a noncompression the SPS Screws have a hexagonalhead with a spherical underside andconform fully to the requirements setby ASTM F138 & F139/ISO 5832-1standards. All the cortical screwswithin the range are cutting flutes on the tip of eachscrew allows cleaner cutting and helpto avoid compacting of the bonechips at the tip of the screw.

4 Due tospecially designed grooves, the screwoffers an enhanced insertion , the bone splinters thatmay accumulate are pushed forwardand kept out of the way of the threadthus preventing possible pressurenecrosis. The range of different screwlengths has been increased and modifiedaccording to different anatomicalregions. Depending on the individualplate thickness, the screw heads can be almost completely countersunk intothe specifically designed plate addition to the cortical screws,cancellous screws may also be CompositionASTM F138 & F139/ISO 5832-1 andASTM F136/ISO 5832-3 materialstandards provide rigid specificationswhich define the chemical composition,microstructural characteristics andmechanical properties of implantquality Stainless Steel and TitaniumAlloy respectively. These standardsensure that Stainless Steel 316 LVM and Titanium Alloy Ti-6Al-4V, even if provided by different suppliers,is consistent and material used for all SPS platesand screws meets these Design TeamProf.

5 Thierry B gu H pital avicenne , Paris, FranceProf. Dr. med. Volker B hrenBG Unfallklinik, Murnau, GermanyGary S. Gruen of Pittsburgh Medical Center, Pittsburgh, USAProf. Dr. med. Hans-UlrichLangendorffUnfallklinik, Klinikum Dortmund,GermanyMichael Prayson of Pittsburgh Medical Center, Pittsburgh, USAR obert Probe and White Memorial Hospital,Texas, USAM elvin Rosenwasser Presbyterian MedicalCenter, New York, USAWe would also like to thank variousOperating Room Nurses andSterilisation Staff for their help duringthe pre-market evaluation System is designed with the kind collaboration of the following Surgeons:IntroductionCases and TraysThe Basic Fragment Set consists offour individual bases containingplates, screws, general instruments,reduction clamps and forceps availablein either plastic or metal.* The threeplate racks, screw rack and tray insertsoffer optimum modularity for storageand sterilisation.

6 The vertical pop-up rack allows for easy access to all theinstruments which are arranged in a logical order, whilst minimising overhang on the instrument table.*reduction case only available in plastic4 ScrewsThe independent screw rack of theBasic Fragment Set offers acomprehensive range of self-tapping and screws. All screws can easily be used through the plate or as independent interfragmentaryLag Screws. Three options of threadlength on the cancellous screwspresents the surgeon with greaterintra-operative flexibility in screwfixation dependent on the size andquality of andForcepsThe range of clamps and reductionforceps available within the system hasbeen optimised for greater performanceand ease of use. The clamps aredesigned to be versatile and easilyinserted into small incisions withoutrestricting vision. This offers greatermanoeuvrability and the unconstraineduse of additional instrumentationduring the surgical combination of ratchet andspeedlock mechanisms extends thesurgeon greater accuracy andconfidence in reduction new system design is based on input from key clinicians, theatre andsterilisation staff.

7 Data from literature and both practical and biomechanicaltesting results of the Steel or Titanium Patient compatibility and surgeon implant rangepreference Multiple plate options Increased indication coverage all in one setRounded and tapered plate ends Reduced potential for soft-tissue irritationEasier placement of plate during sub-cutaneous screw hole options Flexibility of cortical or cancellous screwsK-wire and reduction holes Enhanced primary/temporary plate and fracture fixationEqual hole spacing on straight plates Greater operative flexibility for screw and plate placementLow screw head profile in plate hole Reduced potential for soft-tissue irritationStaggered hole spacing on Broad Reduced potential for longitudinal Compression plate fissures during screw insertionUniform bending stiffness in Equal bending force distribution for Waisted Compression plate increased fatigue strength and contourabilitySpeciality Reconstruction plate Extended indicationsoptionally availableBi-directional holes Allows compression and/or distractionSelf-tapping screws Quick, simple and efficientSharp Hook, Ballspike.

8 Periosteal and Modified design for ease of useFreer ElevatorBending Irons Designed for easy plate contouringClosed design to capture plate during bending for security of useBending Templates Facilitates quicker anatomical contouring of the plateElastosil Handles Ergonomic feel and better gripDoes not retain heat after sterilisationScrewdriver Holding Sleeve Efficiency in screw pick-up and insertion /removal via a No-touch techniqueRetractors/Clamps Specialist forceps and optimised clamp designModular Case design Maximum flexibility for sterilisation method in either outer base or in sterilisation container Lighter for transportation purposesFeatures and Benefits6 The SPS Basic Fragment Setimplants may also be used inrevision surgery ofpseudoarthroses, non-union andmal-union. Osteotomies,arthrodeses and ligament re-attachment may also be performedusing these implants with theapplicable operative PlateFractures of the tibial Plate NarrowFractures of the tibia (femur and humerus).

9 Compression Plate BroadFractures of the femur and PlateFractures of the tibial of the SPS Basic FragmentSet are indicated for fractures in thefollowing areas as shown below:ContraindicationsThe physician's education, trainingand professional judgement must be relied upon to choose the mostappropriate device and presenting an increasedrisk of failure include:Any active or suspected latent infectionor marked local inflammation in or about the affected vascularity that wouldinhibit adequate blood supply to thefracture or the operative stock compromised by disease,infection or prior implantation thatcan not provide adequate support and /or fixation of the sensitivity, documented or An overweight or obesepatient can produce loads on theimplant that can lead to failure of thefixation of the device or to failure of the device having inadequate tissuecoverage over the operative utilization that wouldinterfere with anatomical structures or physiological mental or neuromuscular disorderwhich would create an unacceptablerisk of fixation failure or complicationsin postoperative medical or surgical conditionswhich would preclude the potentialbenefit of of the proximalhumerus and tibial plateau(distal tibia).

10 When the thread of a screw only takespurchase in the far cortex of the bone,this is known as a screw thread takes no purchase in the near cortex of the bone eitherbecause the screw shaft has no threador the drill hole in the near cortex is equal or greater than the outsidediameter of the screw. The near cortexhas to be overdrilled therefore to createa gliding hole. This will ensure thatthe screw thread will only take purchasein the area leading to the far cortex or threaded such a screw is inserted andtightened, it causes the two fragmentsof bone to be Interfragmentary CompressionWhen a Lag-Screw is inserted at rightangles to the fracture line this providesa maximum of interfragmentalcompression but a minimum of axialstability. The loss of reduction andfixation will occur when the twofragments start to glide on each otherunder axial load. It is often preferredtherefore, when using multiple screwsto insert one at right angles to the axisof the bone and the others at rightangles to the fracture this spiral fracture, which is fixed using multiple screws, the central screw is at90 to the long axis of the bone and will ensure axial stability.