Degenerative and Deformity Rods. Posterior thoracolumbar rod offering.

Transcription

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

2 Understanding the material, diameter, strength and stiffness of spinal rods is paramount for maintaining correction.

3 Degenerative and Deformity Rods

4 Yield Strength The following charts represent the differences between the strength and stiffness of rod diameters and materials (including cobalt chromium) within the posterior thoracolumbar rod offering. Definition The stress (force per unit area) at which permanent deformation begins (yields) 5 Properties Different materials have different yield strengths 1-5 Larger rod diameters have greater resistance to deformation at the tensile yield point (of the same material) 5 Greater yield strengths result in longer fatigue life 2 Manufactured condition affects yield strength, not stiffness 2-4 Rod Materials and Diameters Yield strength comparison to 5.5 mm (hard) % 160% 140% +53% +58% 120% 100% +18% +22% +30% +32% 80% -12% -8% 60% -25% -24% -27% 40% 20% -64% 0% 5.0 mm 5.5 mm 6.0 mm Material (Manufactured Condition) ( TiAlNb 316L ( ( TiAlNb CoCrMo CP Ti3 (Soft) (Soft) ( TiAlNb 316L (Soft) 316L ( CoCrMo * Test data on file at and available on request. Degenerative and Deformity Rods

5 Stiffness Definition The measure of the stress per unit strain in the elastic region of the material (material returns to its original shape when the force is removed) 5 Properties Different materials have different moduli of elasticity 1-5 Greater modulus of elasticity results in increased rod stiffness 5 Larger rod diameters provide greater stiffness (of the same material) 5 Rod Materials and Diameters Stiffness comparison to 5.5 mm (hard) % 300% +228% 250% 200% +132% +153% +153% 150% 100% +22% +1% +40% +42% +42% +43% 50% -32% -31% 0% 5.0 mm 5.5 mm 6.0 mm Material (Manufactured Condition) ( TiAlNb 316L ( ( TiAlNb CoCrMo CP Ti3 (Soft) (Soft) ( TiAlNb 316L (Soft) 316L ( CoCrMo * Test data on file at and available on request.

6 Comprehensive Rod Selection. Degenerative and Deformity Rods

7 Cobalt Chromium Rods Properties Extra hard material designed to maintain correction 1 Increased stiffness over stainless steel rods and can be used with titanium implants 1 Similar feel to stainless steel with less spring-back and more bend control than titanium and Ti-6Al-7Nb Increase spinal canal visualization with superior MR imaging compared to stainless steel* Rod Selection Applying these factors will help determine rod selection Rod Diameter 5.0 mm 5.5 mm 6.0 mm Material 316L TiAINb TiAINb CoCrMo 316L 316L TiAINb ( ( hard) ( hard) hard) (Soft) (Soft) ( ( hard) Indications Degenerative Trauma Deformity Complex Deformity Rod Color Light Silver Blue Rose Light Gray Gold Silver Gold Silver Aqua blue red green * Test data on file at and available on request.

8 Product Information 5.0 mm Rods Material 316L Ti-6AI-7Nb Lengths Hard Hard Extra Hard Straight mm mm mm mm mm Precontoured mm straight length, 400 mm mm straight length, 400 mm mm straight length, 400 mm Tapered mm/ 6.0 mm, 500 mm 5.5 mm Rods Material Ti-6AI-7Nb C0-28Cr-6Mo Lengths Hard Extra Hard Extra Hard Curved mm mm mm mm mm mm mm mm mm mm mm mm mm Straight mm mm mm mm Hex-End mm Precontoured mm straight length, 400 mm Tapered mm/ 6.0 mm, 500 mm mm/5.5 mm, 500 mm mm/5.5 mm, 500 mm Degenerative and Deformity Rods

9 6.0 mm Rods Materials 316L 316L Ti-6AI-7Nb Lengths Soft Hard Soft Hard Extra Hard Curved mm mm mm mm mm mm mm mm mm mm mm Straight mm mm mm mm mm mm mm mm mm mm mm mm Hex-End mm mm mm mm Precontoured mm straight length, 400 mm mm straight length, 400 mm mm straight length, 400 mm Note: Product listing in order of material hardness grades (soft to extra hard).

10 References 1. Carpenter Technology Corporation. Technical Datasheet Bio-Dur CCM Alloy. CRS Holdings Inc, Disegi, John. Titanium-6% Aluminum-7% Niobium Implant Material, 2nd edition. (USA), Disegi, John. Unalloyed Titanium Implant Material, 6th edition. (USA), Disegi, John. Wrought-18% Chromium-14% Nickel-2.5% Molybdenum Stainless Steel Implant Material, 3rd edition. (USA), Beer, F.P, and Johnson, E.R. Mechanics of Materials. McGraw-Hill, Degenerative and Deformity Rods

11 Indications The 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 mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and 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 the posterior pedicle screw construct. When used with the 3.5 mm/6.0 mm parallel connectors, the USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5 mm/5.0 mm parallel connectors, the Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0 mm/6.0 mm parallel connectors, the Small Stature USS can be linked to the USS 6.0 mm rod systems. In addition, USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors. 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 list of indications, contraindications, warnings and/or precautions. When used with the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm tapered rods, the USS 6.0 mm rod systems can be linked 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 the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0 mm tapered rods, the USS 6.0 mm rod systems can be linked to the MATRIX System.

12 Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) , Inc. or its affiliates. All rights reserved. Axon, CerviFix, Click X, Pangea and are trademarks of, Inc. or its affiliates. Printed in U.S.A. 11/10 J A