Degenerative and Deformity Rods. Posterior thoracolumbar...

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Instruments and implants approved by the AO Foundation Degenerative and Deformity Rods. Posterior thoracolumbar rod offering.

Transcript of Degenerative and Deformity Rods. Posterior thoracolumbar...

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Instruments and implants approved by the AO Foundation

Degenerative and Deformity Rods.Posterior thoracolumbar rod offering.

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Understanding the material, diameter, strengthand stiffness of spinal rods is paramount for maintaining correction.

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Degenerative and Deformity Rods

Synthes

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Synthes Degenerative and Deformity Rods

Yield Strength

Properties

– Different materials have differentyield strengths1-5

– Larger rod diameters have greater resistance to deformation at the tensile yield point (of the same material)5

– Greater yield strengths result inlonger fatigue life2

– Manufactured condition affects yieldstrength, not stiffness2-4

180%

160%

140%

120%

100%

80%

60%

40%

20%

0%5.0 mm 5.5 mm 6.0 mm

-25%

-12%

-24%

-27%

-8%

-64%

+18

%

+22

% +30

%

+53

%

+32

%

+58

%

CP Ti4(Hard)

TiAlNb(Extra Hard)

316L(Hard)

316L(Soft)

316L(Hard)

CP Ti4(Hard)

CP Ti3(Soft)

CP Ti4(Soft)

CP Ti4(Hard)

TiAlNb(Extra Hard)

TiAlNb(Extra Hard)

CoCrMo(Extra Hard)

CoCrMo(Extra Hard)

Material

(ManufacturedCondition)

Rod Materials and Diameters

Yield strength comparison to 5.5 mm CP Ti4 (hard)1-5

The following charts represent the differences between the strength andstiffness of rod diameters and materials(including cobalt chromium) within the Synthes posterior thoracolumbarrod offering.

Definition

– The stress (force per unit area) atwhich permanent deformation begins (yields)5

* Test data on file at Synthes and available on request.

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Synthes

* Test data on file at Synthes and available on request.

Stiffness

Definition

– The measure of the stress per unitstrain in the elastic region of the material (material returns to its originalshape when the force is removed)5

350%

300%

250%

200%

150%

100%

50%

0%5.0 mm 5.5 mm 6.0 mm

-32%

-31%

+22

%

+1%

+132

%

+40

%

+42

%

+42

%

+43

%

+15

3%

+15

3%

+22

8%

CP Ti4(Hard)

TiAlNb(Extra Hard)

316L(Hard)

316L(Soft)

316L(Hard)

CP Ti4(Hard)

CP Ti3(Soft)

CP Ti4(Soft)

CP Ti4(Hard)

TiAlNb(Extra Hard)

TiAlNb(Extra Hard)

CoCrMo(Extra Hard)

CoCrMo(Extra Hard)

Material

(ManufacturedCondition)

Rod Materials and Diameters

Stiffness comparison to 5.5 mm CP Ti4 (hard)1-5

Properties

– Different materials have different moduli of elasticity1-5

– Greater modulus of elasticity results in increased rod stiffness5

– Larger rod diameters provide greaterstiffness (of the same material)5

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Synthes Degenerative and Deformity Rods

ComprehensiveRod Selection.

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Synthes

Cobalt Chromium Rods

Properties

– Extra hard material designed tomaintain correction1

– Increased stiffness over stainless steelrods and can be used with titaniumimplants1

– Similar feel to stainless steel with lessspring-back and more bend controlthan titanium and Ti-6Al-7Nb

– Increase spinal canal visualizationwith superior MR imaging comparedto stainless steel*

Rod Diameter 5.0 mm 5.5 mm 6.0 mm

Material CP Ti4 316L TiAINb CP Ti4 TiAINb CoCrMo CP Ti4 316L CP Ti4 316L TiAINb

(Hard) (Hard) (Extra hard) (Hard) (Extra hard) (Extra hard) (Soft) (Soft) (Hard) (Hard) (Extra hard)

Indications

Degenerative � � � � �

Trauma � � � � � � �

Deformity � � � � � � � � �

Complex � � � � �Deformity

Rod Color Light Silver Blue Rose Light Gray Gold Silver Gold Silver Aqua

blue red green

Rod Selection

Applying these factors will help determine rod selection

* Test data on file at Synthes and available on request.

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Synthes Degenerative and Deformity Rods

Product Information

5.0 mm Rods

Material CP Ti4 316L Ti-6AI-7Nb LengthsHard Hard Extra Hard

Straight 498.236 298.236 -- 150 mm498.237 298.237 498.492 200 mm498.239 298.239 498.494 300 mm498.241 298.241 498.495 400 mm498.243 298.243 498.496 500 mm

Precontoured 04.600.004 02.600.004 – 50 mm straight length, 400 mm04.600.006 02.600.006 – 65 mm straight length, 400 mm04.600.008 02.600.008 – 80 mm straight length, 400 mm

Tapered – 298.944 498.944 5.0 mm/6.0 mm, 500 mm

5.5 mm Rods

Material CP Ti4 Ti-6AI-7Nb C0-28Cr-6Mo LengthsHard Extra Hard Extra Hard

Curved 04.636.030 – 09.636.030 30 mm 04.636.035 – 09.636.035 35 mm 04.636.040 – 09.636.040 40 mm 04.636.045 – 09.636.045 45 mm 04.636.050 – 09.636.050 50 mm 04.636.055 – 09.636.055 55 mm 04.636.060 – 09.636.060 60 mm 04.636.065 – 09.636.065 65 mm 04.636.070 – 09.636.070 70 mm 04.636.075 – 09.636.075 75 mm 04.636.080 – 09.636.080 80 mm 04.636.085 – 09.636.085 85 mm 04.636.125 – 09.636.125 125 mm

Straight 04.633.292 04.633.282 09.633.190 200 mm04.633.293 04.633.283 09.633.191 300 mm04.633.294 04.633.284 09.633.192 400 mm04.633.295 04.633.285 09.633.193 500 mm

Hex-End 04.633.500 04.633.286 09.633.500 500 mm

Precontoured 04.633.280 04.633.185 09.633.185 80 mm straight length, 400 mm

Tapered 04.633.187 04.633.188 09.633.187 5.5 mm/6.0 mm, 500 mm– 04.633.190 – 3.5 mm/5.5 mm, 500 mm– 04.633.191 – 4.0 mm/5.5 mm, 500 mm

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Synthes

6.0 mm Rods

Materials CP Ti4 CP Ti4 316L 316L Ti-6AI-7Nb LengthsSoft Hard Soft Hard Extra Hard

Curved 04.620.135 – – – – 35 mm 04.620.140 – – – – 40 mm 498.139 – – – – 45 mm

04.620.150 – – – – 50 mm 498.140 – – – – 55 mm

04.620.160 – – – – 60 mm 498.141 – – – – 65 mm

04.620.170 – – – – 70 mm 498.142 – – – – 75 mm

04.620.180 – – – – 80 mm498.143 – – – – 85 mm

Straight 498.150 498.102 298.150 298.102 – 50 mm 498.151 498.103 298.151 298.103 – 75 mm 498.152 498.104 298.152 298.104 – 100 mm498.153 498.105 298.153 298.105 – 125 mm498.154 498.106 298.154 298.106 – 150 mm– 498.108 – 298.108 498.290 200 mm– 498.110 – 298.110 – 250 mm– 498.112 – 298.112 498.292 300 mm– 498.114 – 298.114 – 350 mm– 498.116 – 298.116 498.294 400 mm– 498.118 – 298.118 – 450 mm498.158 498.119 – 298.119 498.296 500 mm

Hex-End – 04.622.314 02.622.314 04.622.352 200 mm – 04.622.315 – 02.622.315 04.622.353 300 mm – 04.622.316 – 02.622.316 04.622.354 400 mm – 04.622.317 – 02.622.317 04.622.355 500 mm

Precontoured – 04.600.014 – 02.600.014 – 50 mm straight length, 400 mm– 04.600.016 – 02.600.016 – 65 mm straight length, 400 mm– 04.600.018 – 02.600.018 – 80 mm straight length, 400 mm

Note: Product listing in order of material hardness grades (soft to extra hard).

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Synthes Degenerative and Deformity Rods

1. Carpenter Technology Corporation. Technical DatasheetBio-Dur® CCM® Alloy. CRS Holdings Inc, 2009.

2. Disegi, John. Titanium-6% Aluminum-7% Niobium Implant Material, 2nd edition. Synthes (USA), 2008.

3. Disegi, John. Unalloyed Titanium Implant Material, 6th edition. Synthes (USA), 2008.

4. Disegi, John. Wrought-18% Chromium-14% Nickel-2.5%Molybdenum Stainless Steel Implant Material, 3rd edition.Synthes (USA), 2009.

5. Beer, F.P, and Johnson, E.R. Mechanics of Materials. McGraw-Hill, 1981.

References

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Synthes

In addition, Synthes USS 6.0 mm rod systems can be inter-changed with all USS 6.0 mm rods and transconnectors.

Synthes USS– 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening,USS VAS variable axis components, USS Fracture, Click’X,Click’X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix

– 5.5 mm Rod System: MATRIX

– 5.0 mm Rod System: USS Small Stature

CerviFix – 3.5 mm Rod Systems: CerviFix, Axon, Synapse

– 4.0 mm Rod System: Synapse

Please refer to package insert (GP2774) for the full listof indications, contraindications, warnings and/or precautions.

The Synthes USS are noncervical spinal fixation devices intended for posterior pedicle screw fixation (T1–S2/ ilium),posterior hook fixation (T1–L5), or anterolateral fixation (T8–L5). Pedicle screw fixation is limited to skeletally maturepatients with the exception of the Small Stature USS, whichincludes small stature and pediatric patients. These devicesare indicated as an adjunct to fusion for all of the followingindications: degenerative disc disease (defined as discogenicback pain with degeneration of the disc confirmed by historyand radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis, Scheuermann’s Disease), tumor,stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with degenerative disc disease (DDD), transverse bars are not cleared for use as part of theposterior pedicle screw construct.

When used with the 3.5 mm/6.0 mm parallel connectors,the Synthes USS 6.0 mm rod systems can be linked to theCerviFix 3.5 mm Systems. In addition, when used with 3.5 mm/5.0 mm parallel connectors, the Synthes SmallStature USS can be linked to the CerviFix 3.5 mm Systems.When used with the 5.0 mm/6.0 mm parallel connectors,the Synthes Small Stature USS can be linked to the SynthesUSS 6.0 mm rod systems.

When used with the 3.5 mm/6.0 mm and 4.0 mm/6.0 mmtapered rods, the Synthes USS 6.0 mm rod systems can belinked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm tapered rods, MATRIX can be linked to theCerviFix 3.5 mm and 4.0 mm Systems, respectively. Whenused with the 5.5 mm/6.0 mm tapered rods, the SynthesUSS 6.0 mm rod systems can be linked to the MATRIX System.

Indications

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Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2010 Synthes, Inc. or its affiliates. All rights reserved. Axon, CerviFix, Click’X, Pangea and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 11/10 J10110 -A

www.synthes.com