Your single source for VCF solutions.

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1 Stryker Interventional Spine. Your single source for VCF solutions. StrykerIVS.com

$The benefit of choice. The advantage of Stryker. Osteoporotic fractures are a serious and growing problem for older adults and the healthcare system.$

2 The benefit of choice. The advantage of Stryker. Osteoporotic fractures are a serious and growing problem for older adults and the healthcare system. In fact, one in two women and one in four men will have an osteoporotic fracture during their lifetime. 1 Vertebral compression fractures (VCFs) are the most common with an estimated 700,000 such fractures reported each year. 2, 3 Relieving pain. Improving lives. With the addition of Cortoss Bone Augmentation Material, Stryker offers you a broad portfolio of products for VCF treatments. From our new ivas Inflatable Vertebral Augmentation System to our mixer and delivery systems, cements, and needles, our unprecedented portfolio of products lets you customize your treatment approach. In fact, Stryker s product configurations offer more flexibility, which helps contain costs and avoid waste.

$Vertebroplasty involves injection of bone cement or bioactive composite 15,16 directly into a fractured vertebral body from a percutaneous approach.$ $The hardened cement or bioactive composite 15,16 stabilizes the fracture, relieving pain.$

3 Every spine is unique. Now your treatment options are too. Vertebroplasty involves injection of bone cement or bioactive composite 15,16 directly into a fractured vertebral body from a percutaneous approach. The hardened cement or bioactive composite 15,16 stabilizes the fracture, relieving pain. 4,5 Vertebral augmentation is a treatment option for vertebral compression fractures that creates a void in the cancellous bone by way of an inflated balloon. This procedure helps ensure controlled and contained cement delivery into the factured vertebral body. Vertebroplasty Vertebral compression fracture is identified Needle is guided into fractured vertebra using fluoroscopy Vertebral Augmentation Needle is guided into fractured vertebra using fluoroscopy Hand drill is inserted into the anterior third of the vertebral body to create a pathway Clinical results for both procedures show substantial pain relief 2,6 in approximately 90% of patients 6 and potentially a significant increase in quality of life. 2,7 Bone cement or bioactive composite is injected Balloon catheter is inserted into the fractured vertebra Stabilized vertebral body The balloon is inflated, compacting the trabeculae and creating a cavity Once the balloon is deflated and withdrawn, the cavity is filled with bone cement Stabilized vertebral body

Stryker Bioactive Composite Cortoss Bone Augmentation Material Cortoss is an injectable, non-resorbable composite consisting of cross-linking resins and reinforcing glass ceramic particles.

4 Stryker Bioactive Composite Cortoss Bone Augmentation Material Cortoss is an injectable, non-resorbable composite consisting of cross-linking resins and reinforcing glass ceramic particles. It has been clinically proven to meet the safety and effectiveness of Polymethylmethacrylate (PMMA) for vertebral augmentation. Cortoss material properties create flow characteristics and fill patterns that may improve procedural safety and control. Features Flow and Fill: Properties improve short-term pain and long-term function 15 Safety: Low incidence of adjacent fractures* 15 ; minimal exotherm 17 and monomer release 18 Control: Procedural flexibility with mix-on-demand and start/stop delivery 19 Data: Robust compilation of clinical data 19 * In patients with one level treated and no previous fracture Orthovita founded Cortoss development - a bioactive glass filled composite 16 US IDE Pilot Study: Vertebroplasty CE Mark Vertebral Augmentation US IDE Pilot Study: Kyphoplasty US IDE Pivotal Study: Vertebroplasty FDA Cleared: Vertebral Augmentation Stryker acquired Orthovita

$first-time fracture at one level,$ $adjacent level fractures in the$

5 International Multi-Center Clinical Trials Clinical testing provides the proof. 15 The safety and efficacy of Cortoss have been demonstrated in an extensive multi-centre clinical study involving three U.S. and multiple European centres 15 30% less material was required during vertebroplasty to achieve desired fill patterns 15 In patients with a first-time fracture at one level, there was a 43% reduction in adjacent level fractures in the Cortoss patient population 15 Axial View Coronal View Sagittal View

6 Stryker Aliquot Accessories Aliquot Delivery System With mix-on-demand, working time is no longer a concern. The Cortoss pastes are contained in a ready-touse dual chamber cartridge Material preparation is an on-demand process that takes seconds to complete The concern of working time is irrelevant with Cortoss as fresh material is available as the need arises Ordering Information Cortoss Cortoss Cartridge, 5cc Cortoss Cartridge, 10cc Mixing and Delivery Gun Mixing and Delivery Gun (Reusable) Mix-Tips, Leur (qty 3) Syringe Delivery System Kit Syringe Delivery System, 4" Includes: 11g 4" Bevel Tip needle, 11g 4" Diamond Tip needle, 13g 6" Reamer, 13g 6" Catheter (qty 5), Side-port syringe (qty 5) Plunger Delivery System Kit Plunger Delivery System, 4" Includes: 11g 4" Bevel Tip needle, 11g 4" Diamond Tip needle, 13g 6" Reamer, 13g 6" Catheter (qty 5), 13g 6" Plunger (qty 5)

Start and stop delivery as required until treatment goals are achieved Ordering Information, continued Aliquot Delivery System

7 Intuitive injection control is fundamental to start/stop delivery. Procedural flexibility if leaks are detected Procedural control if needle repositioning is required Control of operative workflow Start and stop delivery as required until treatment goals are achieved Ordering Information, continued Aliquot Delivery System g 4" (10cm) Bevel Tip needle g 4" (10cm) Diamond Tip needle g 6" (15cm) Plunger g 6 (15cm) Catheter Flexible Extension Side Loading Syringe

Stryker PMMA Bone Cements Once a benchmark, always a benchmark.

$working time preferences for the treatment of vertebral compression fractures.$ individualized patient care. Over the last three and a half decades, Stryker has implanted more than 23 million doses of bone cement. This expertise is grounded in Stryker s Simplex P Bone Cement.

individualized patient care. Over the last three and a half decades, Stryker has implanted more than 23 million doses of bone cement. This expertise is grounded in Stryker s Simplex P Bone Cement.

8 Stryker PMMA Bone Cements Once a benchmark, always a benchmark. As one of the world s leading manufacturers of bone cement, Stryker continues to set the industry standard by providing physicians with a range of bone cements that address specific viscosity and working time preferences for the treatment of vertebral compression fractures. Stryker s three unique VCF bone cements, compared at right, are indicated for use with percutaneous vertebroplasty and kyphoplasty, providing the flexibility you want and the options you need for individualized patient care. Over the last three and a half decades, Stryker has implanted more than 23 million doses of bone cement. This expertise is grounded in Stryker s Simplex P Bone Cement. In 1971, Simplex P became the first surgical bone cement approved by the FDA for total hip replacement. For more than 40 years, tens of thousands of physicians have trusted Stryker bone cements derived from Simplex P including SpinePlex, VertaPlex, and now VertaPlex HV. Stryker Interventional Spine. Your single source for VCF solutions Simplex C Bone Cement introduced in Europe Simplex P Bone Cement introduced in Europe Simplex P first to receive FDA approval in the U.S. for total hip arthroplasty Simplex P Bone Cement approved for total knee arthroplasty Simplex antibiotic Bone Cement (with Erythromycin and Colistin) introduced in Europe Simplex P approved for pathological fractures and general prosthetic fixation

9 Stryker PMMA Bone Cement Viscosity VertaPlex HV Viscosity (in pa. s) SpinePlex VertaPlex Time (in minutes) Graph 1. Independent lab results from Fluid Dynamics, Inc. commissioned by Stryker, Inc. July Testing conducted at C (68-70 F) Over 15 million doses of Simplex P have been implanted Simplex P with Tobramycin introduced in Europe Simplex P with Tobramycin introduced in U.S. SpinePlex introduced in Europe SpinePlex introduced in U.S. and used in thousands of VCF cases worldwide VertaPlex introduced worldwide VertaPlex HV introduced worldwide

Stryker PMMA Bone Cements VertaPlex HV Ready when you are. VertaPlex HV is a high viscosity bone cement that contributes to improved visibility and control.

Features Immediate high viscosity after mixing Controlled interdigitation and fill Working time approximately 18 minutes Set time of 10.

Straight Short Extension Tube and without Needles Includes: One-half dose of VertaPlex HV bone cement, one PCD mixer and delivery system with straight short extension tube 0607-687-000 (Sterile; 2

10 Stryker PMMA Bone Cements VertaPlex HV Ready when you are. VertaPlex HV is a high viscosity bone cement that contributes to improved visibility and control. VertaPlex HV reaches a thick viscosity as soon as it s mixed and maintains its viscous state for an average of 18 minutes. Features Immediate high viscosity after mixing Controlled interdigitation and fill Working time approximately 18 minutes Set time of 10.2 minutes at 37ºC Lower creep rate Increased viscosity improves visibility 30% barium sulfate concentration Ordering Information (Sterile; 2 per box) VertaPlex HV / PCD System Kit with Straight Short Extension Tube and without Needles Includes: One-half dose of VertaPlex HV bone cement, one PCD mixer and delivery system with straight short extension tube (Sterile; 2 per box) AutoPlex System Kit with VertaPlex HV without Needles Includes: One -half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system A là carte (Sterile; 2 per box) SpinePlex 20 Gram Twin Pack (One-half Dose (Sterile; 2 per box) VertaPlex 20 Gram Twin Pack (One-half Dose) (Sterile; 2 per box) VertaPlex HV 20 Gram Twin Pack (One-half Dose)

Advantageous for multiple level vertebroplasties and kyphoplasties, VertaPlex maintains its toothpaste-like

Features Increased working time approximately 20 minutes Set time of 10.

SpinePlex is a derivative of Simplex P Bone Cement the first surgical bone cement approved by the FDA, the

11 VertaPlex Extended working time. Developed for physicians who want lower initial viscosity and longer working time. Advantageous for multiple level vertebroplasties and kyphoplasties, VertaPlex maintains its toothpaste-like consistency for an average of 20 minutes. Features Increased working time approximately 20 minutes Set time of 10.2 minutes at 37ºC Low creep rate 30% barium sulfate concentration SpinePlex Proven performance. SpinePlex is a derivative of Simplex P Bone Cement the first surgical bone cement approved by the FDA, the first antibiotic-laden bone cement approved by the FDA, 8 and the most widely used bone cement in the world. 9 SpinePlex contains the same polymethylmethacrylate (PMMA) and is manufactured using the same proprietary process. Features minutes at 37ºC concentration Recommended Companion Products VertaPlex HV VertaPlex SpinePlex

Stryker Vertebral Augmentation ivas: Inflatable Vertebral Augmentation System The ivas Inflatable Vertebral Augmentation System is your complete solution for treating VCFs with kyphoplasty.

2,11 Clinical results for kyphoplasty show the potential for substantial pain relief, 13 increased mobility, and improved quality of life. 2,5,6,7,10,11,12 Simple. Certain. Defined.

12 Stryker Vertebral Augmentation ivas: Inflatable Vertebral Augmentation System The ivas Inflatable Vertebral Augmentation System is your complete solution for treating VCFs with kyphoplasty. During a kyphoplasty, a balloon catheter is used to create a void in a collapsed vertebra, helping to allow for controlled and contained cement delivery. 2,11 Clinical results for kyphoplasty show the potential for substantial pain relief, 13 increased mobility, and improved quality of life. 2,5,6,7,10,11,12 Simple. Certain. Defined. ivas measures up to your expectations and your expertise. Ordering Information ivas System Kits All the kits include: Balloon catheter, access cannula with diamond tip stylet, bevel tip stylet, locking syringe, stopcock (Sterile; 3 per box) g ivas System Kit (10 mm) g ivas System Kit (15 mm) g ivas System Kit (20 mm) g ivas System Kit (10 mm) g ivas System kit (15 mm) g ivas System kit (20 mm) ivas à la carte (Sterile; 3 per box) 20 mm ivas Balloon à la carte (Sterile; 3 per box) 15 mm ivas Balloon à la carte (Sterile; 3 per box) 10 mm ivas Balloon à la carte Supplemental (Sterile; 6 per box) 8g Hand Drill (Sterile; 18 per box) 8g VertePort Cement Cannulae g Bone Biopsy Kit (Sterile; 6 per box) 10g Hand Drill (Sterile; 18 per box) 10g VertePort Cement Cannulae (Sterile; 6 per box) 10g Bone Biopsy Kit

Balloon Catheter Stiff distal balloon catheter provides rigidity for smooth insertion Flexible proximal catheter allows

placement of the balloon Unipedicular Kyphoplasty Access Cannula / Stylet The hand drill cuts cleanly through cancellous

depth Specifications Inflated Balloon Dimensions (as tested in water at 37 C) (10 mm) (15 mm) (2-20 mm) Volume: 2 ml 4

3 mm Diameter (D): 11.6 mm 15.5 mm 10.9 mm 14.9 mm 16.0 mm 10.8 mm 16.0 mm 18.

[27 atm] 400 psi [27 atm] Recommended Companion Products Procedure Overview AutoPlex PCD VertePort All PMMA Cements Bone

13 Balloon Catheter Stiff distal balloon catheter provides rigidity for smooth insertion Flexible proximal catheter allows for easy maneuverability The radiopaque markers on the balloon catheter help facilitate accurate visualization and placement of the balloon Unipedicular Kyphoplasty Access Cannula / Stylet The hand drill cuts cleanly through cancellous bone to create a channel for balloon placement Graduation markings on the access cannula assist in measuring needle depth Specifications Inflated Balloon Dimensions (as tested in water at 37 C) (10 mm) (15 mm) (2-20 mm) Volume: 2 ml 4 ml 2 ml 4 ml 5 ml 2 ml 4 ml 6 ml Length (L): 15.1 mm 21.1 mm 16.7 mm 24.0 mm 27.0 mm 19.0 mm 24.6 mm 29.3 mm Diameter (D): 11.6 mm 15.5 mm 10.9 mm 14.9 mm 16.0 mm 10.8 mm 16.0 mm 18.3 mm Bipedicular Kyphoplasty Maximum Balloon Inflation Values Volume: 4 ml 5 ml 6 ml Pressure: 400 psi [27 atm] 400 psi [27 atm] 400 psi [27 atm] Recommended Companion Products Procedure Overview AutoPlex PCD VertePort All PMMA Cements Bone Biopsy Kit The balloon is inflated, compacting the trabeculae and creating a cavity Once the balloon is deflated and withdrawn, the cavity is filled with bone cement Stabilized vertebral body

Mixing in less than 60 seconds, streamlining procedure time Ordering Information Recommended Companion Products 0605-887-000 (Sterile; 2 per box) AutoPlex System Kit without Cement or

14 Stryker Mixer & Delivery Systems AutoPlex Mixer & Delivery System AutoPlex is a fast and easy-to-use mixer and delivery system. With the press of a single button, it mixes, transfers, and primes (ready to inject) highly viscous bone cement for delivery in less than 60 seconds. Mixing in less than 60 seconds, streamlining procedure time Ordering Information Recommended Companion Products (Sterile; 2 per box) AutoPlex System Kit without Cement or Needles Includes: One AutoPlex mixer and delivery system ivas SpinePlex VertaPlex VertaPlex HV VertePort Cement Cannulae (Sterile; 2 per box) AutoPlex System Kit with VertaPlex HV without Needles Includes: One -half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system

15 Delivery prevents exposure to harmful fumes totaling 16" in length, helps ensure radiation safety Procedure Overview Attach extension tube to delivery cartridge, pour powder and then liquid monomer through supplied funnel Lock lid onto mixing chamber Press and release mixing button Detach tube from cement injector when mixing/transfer are complete Remove cement injector from mixing unit

Stryker Mixer & Delivery Systems PCD: Precision Cement Delivery An all-in-one mixer and delivery system, PCD offers ease of use, desired cement consistency, and helps improve procedure efficiency.

4 cc per full turn of delivery base safety with more than 14" in total length Ordering Information Recommended Companion Products 0506-482-000 (Sterile; 4 per box) 10g PCD System Kit without Cement

without Cement Includes: One PCD mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle, one 11g 5" interchangeable bevel stylet 0506-485-000 (Sterile; 4 per box) 13g PCD

16 Stryker Mixer & Delivery Systems PCD: Precision Cement Delivery An all-in-one mixer and delivery system, PCD offers ease of use, desired cement consistency, and helps improve procedure efficiency. Mixing Delivery 0.4 cc per full turn of delivery base safety with more than 14" in total length Ordering Information Recommended Companion Products (Sterile; 4 per box) 10g PCD System Kit without Cement Includes: One PCD mixer and delivery system, one 10g 5" diamond tip match-ground introduction needle, one 10g 5" interchangeable bevel stylet (Sterile; 4 per box) 11g PCD System Kit without Cement Includes: One PCD mixer and delivery system, one 11g 5" diamond tip match-ground introduction needle, one 11g 5" interchangeable bevel stylet (Sterile; 4 per box) 13g PCD System Kit without Cement Includes: One PCD mixer and delivery system, one 13g 5" diamond tip match-ground introduction needle, one 13g 5" interchangeable bevel stylet (Sterile; 4 per box) PCD System Kit without Cement or Needles Includes: One PCD mixer and delivery system (Sterile; 4 per box) PCD System Kit with Straight Short Extension Tube and without Cement or Needles Includes: One PCD mixer and delivery system with straight short extension tube ivas VertaPlex HV (short tube only) VertaPlex SpinePlex (one-half dose) VertePort

17 VertaPlex HV only compatible with short tube. Procedure Overview Pour powder and monomer into funnel Attach mixing blade and lock into place Mix cement in an up and down motion while rotating the mixing handle Remove hand mixer: push grey button inward, rotate clockwise, then pull handle straight up and out of mix chamber Lock the delivery cartridge with the extension tube attached onto the mixing chamber by rotating counterclockwise Transfer and prime system by turning the base of the mixing chamber clockwise

Stryker VCF Accessories Vertebral Bone Biopsy Kit The Stryker Bone Biopsy Kit is compatible with our standard 10, 11, and 13 gauge 5" needles, as well as 10 gauge 9" needles.

Features image of bony landmarks and precise needle placement Ordering Information Recommended Companion Products 0306-125-000: (Sterile; 6 per box) 8g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial

18 Stryker VCF Accessories Vertebral Bone Biopsy Kit The Stryker Bone Biopsy Kit is compatible with our standard 10, 11, and 13 gauge 5" needles, as well as 10 gauge 9" needles. The coaxial design allows for biopsy collection of a core sample within the vertebral body. This streamlined technique can be used in conjunction with VCF procedures or independent biopsies. Features image of bony landmarks and precise needle placement Ordering Information Recommended Companion Products : (Sterile; 6 per box) 8g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet (Sterile; 6 per box) 10g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet (Sterile; 6 per box) 10g 9" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet (Sterile; 6 per box) 11g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet (Sterile; 6 per box) 13g 5" Bone Biopsy Kit Includes: Blunt tip, coaxial needle, inner stylet All PMMA Cements All Mixers and Delivery Systems 10g 5" Diamond Tip Match-Ground s 10g 9" Diamond Tip Match-Ground s 11g 5" Diamond Tip Match-Ground s 13g 5" Diamond Tip Match-Ground s

Needles Stryker s needles help offer optimal control and maneuverability in accessing the vertebral body and delivering bone cement during VCF treatments.

oriented. 14 Features reducing tissue catching when introduced with cannulae under fluoroscopy These needles are recommended only for Vertebroplasty procedures.

Ordering Information Recommended Companion Products 0306-100-000 (Sterile; 6 per box) 10g 5" Diamond Tip Match-Ground 0306-101-000 (Sterile; 6 per box) 10g 5" Bevel Tip Match-Ground 0306-110-000

19 Needles Stryker s needles help offer optimal control and maneuverability in accessing the vertebral body and delivering bone cement during VCF treatments. The easy-to-introduce match-ground diamond tips are sharp and efficient in cutting bone, while the beveled stylets are useful for changing the tip direction according to which way the bevel is oriented. 14 Features reducing tissue catching when introduced with cannulae under fluoroscopy These needles are recommended only for Vertebroplasty procedures. VertePort needles are optimal for Kyphoplasty. Ordering Information Recommended Companion Products (Sterile; 6 per box) 10g 5" Diamond Tip Match-Ground (Sterile; 6 per box) 10g 5" Bevel Tip Match-Ground (Sterile; 6 per box) 11g 5" Diamond Tip Match-Ground (Sterile; 6 per box) 11g 5" Bevel Tip Match-Ground AutoPlex PCD VertePort All PMMA Cements Bone Biopsy Kit (Sterile; 6 per box) 10g 9" Diamond Tip Match-Ground (Sterile; 6 per box) 13g 4" Diamond Tip Match-Ground and Bevel Stylet (Sterile; 6 per box) 10g 9" Bevel Tip Match-Ground (Sterile; 6 per box) 13g 5" Diamond Tip Match-Ground (Sterile; 6 per box) 11g 4" Diamond Tip Match-Ground and Bevel Stylet (Sterile; 6 per box) 13g 5" Bevel Tip Match-Ground

Stryker VCF Accessories VertePort Coaxial System VertePort is a coaxial, hollow-needle access system developed specifically for vertebral augmentation.

20 Stryker VCF Accessories VertePort Coaxial System VertePort is a coaxial, hollow-needle access system developed specifically for vertebral augmentation. The system offers multiple ways to deliver bone cement during VCF treatments. By providing continuous access to the vertebral body, VertePort increases control while delivering cement with the use of a traditional injector. If used to hand obturate cement delivery, VertePort s mechanical advantage allows for delivery of thicker cement and increased working time compared to traditional injectors and syringes. Ordering Information (Sterile; 6 per box) 11g 5" Short Stylet Access Cannula (Sterile; 18 per box) 10g Cement Cannula Recommended Companion Products ivas (Sterile; 6 per box) 10g 5.75" Long Stylet Access Cannula (Sterile; 18 per box) 8g Cement Cannula AutoPlex PCD (Sterile; 6 per box) 10g 5" Lubricated Access Needle : (Sterile; 6 per box) 8g" Stylet Access Cannula diamond tip All PMMA Cements Bone Biopsy Kit 10g and 11g Needles : (Sterile; 6 per box) 8g" Stylet Access Cannula bevel tip (Sterile; 18 per box) 11g Cement Cannula

21 Features VCF treatment unobstructed access to the vertebral body viscosity bone cement through hand obturation and/or traditional injector with use of hand obturation Approach Overview Coaxial delivery of cement with VertePort Filling of cement cannula using PCD Hand obturation

22 Cortoss Bone Augmentation Material Cortoss Cartridge, 5cc Cortoss Cartridge, 10cc Mixing and Delivery Gun (Sterile) Mixing and Delivery Gun (Resuable) Mix-Tips, Leur (qty 3) Syringe Delivery System Kit Syringe Delivery System, 4 Includes: 11g 4 Bevel Tip needle, 11g 4 Diamond Tip needle, 13g 6 Reamer, 13g 6 Catheter (qty 5), Side-port syringe (qty 5) Plunger Delivery System Kit Plunger Delivery System, 4 Includes: 11g 4 Bevel Tip needle, 11g 4 Diamond Tip needle, 13g 6 Reamer, 13g 6 Catheter (qty 5), 13g 6 Plunger (qty 5) Aliquot Delivery System g 4" (10cm) Bevel Tip Needle g 4" (10cm) Diamond Tip Needle g 6" (15cm) Plunger g 6 (15cm) Catheter Flexible Extension Side Loading Syringe PMMA Bone Cements VertaPlex HV (Sterile; 2 per box) VertaPlex HV 20 Gram Twin Pack (one-half dose) VertaPlex (Sterile; 2 per box) VertaPlex 20 Gram Twin Pack (one-half dose) SpinePlex (Sterile; 2 per box) SpinePlex 20 Gram Twin Pack (one-half dose) ivas Inflatable Vertebral Augmentation System All the kits include: Balloon catheter, access cannula with diamond tip stylet and bevel tip stylet, locking syringe, stopcock g ivas System Kit (Sterile; 3 per box) (10 mm) g ivas System Kit (Sterile; 3 per box) (15 mm) g ivas System Kit (Sterile; 3 per box) (20 mm) g ivas System Kit (Sterile; 3 per box) (10 mm) g ivas System Kit (Sterile; 3 per box) (15 mm) g ivas System Kit (Sterile; 3 per box) (20 mm) ivas à la Carte ivas Balloon Catheter (Sterile; 3 per box) (10 mm) ivas Balloon Catheter (Sterile; 3 per box) (15 mm) ivas Balloon Catheter (Sterile; 3 per box) (20 mm) g Hand Drill (Sterile; 6 per box) g Hand Drill (Sterile; 6 per box) Mixers and Delivery Systems AutoPlex (Sterile; 2 per box) AutoPlex System Kit without Cement or Needles Includes: One AutoPlex mixer and delivery system AutoPlex System Kit with VertaPlex HV without Needles Includes: One-half dose of VertaPlex HV bone cement, one AutoPlex mixer and delivery system PCD (Sterile; 4 per box) g PCD System Kit Includes: One PCD mixer and delivery system, one 10g 5" diamond tip matchground introduction needle, one 10g 5" interchangeable bevel stylet g PCD System Kit Includes: One PCD mixer and delivery system, one 11g 5" diamond tip matchground introduction needle, one 11g 5" interchangeable bevel stylet g PCD System Kit Includes: One PCD mixer and delivery system, one 13g 5" diamond tip matchground introduction needle, one 13g 5" interchangeable bevel stylet PCD System Kit without Needles Includes: One PCD mixer and delivery system PCD System Kit with Straight Short Extension Tube and without Needles Includes: One PCD mixer and delivery system with straight short extension tube VertaPlex HV / PCD System Kit with Straight Short Extension Tube and without Needles Includes: One half dose of VertaPlex HV Bone Cement, one PCD mixer and delivery system with straight short extension tube VertePort Access Cannulae for Kyphoplasty (Sterile; 6 per box) g 5.75" Long Stylet Access Cannula g 5" Access Needle (Diamond tip) g 5" Access Needle (Bevel tip) g 5" Lubricated Access Needle g 5" Diamond Tip Match-Ground Cement Cannulae (Sterile; 18 per box) g Cement Cannula (for use with 11g 5" access needle ) g Cement Cannula (for use with 10g long and short access needles) g Cement Cannula (for use with 8g long and short access needles)

23 Needles for Vertebroplasty (Sterile; 6 per box) NOTES 10g g 5" Diamond Tip Match-Ground g 5" Bevel Tip Match-Ground g 9" Diamond Tip Match-Ground g 9" Bevel Tip Match-Ground 11g g 5" Diamond Tip Match-Ground g 5" Bevel Tip Match-Ground g 4" Diamond Tip Match-Ground and Bevel Stylet 13g g 4" Diamond Tip Match-Ground and Bevel Stylet g 5" Diamond Tip Match-Ground g 5" Bevel Tip Match-Ground 14g g 4.4" Diamond Tip Match-Ground and Bevel Stylet Bone Biopsy Kits (Sterile; 6 per box) g 5" Bone Biopsy Kit g 5 Bone Biopsy Kit g 9" Bone Biopsy Kit g 5" Bone Biopsy Kit g 5" Bone Biopsy Kit

24 Reconstructive Hips Footnotes 1. National Osteoporosis Foundation. Disease facts. Available at: osteoporosis/diseasefacts.htm. Accessed September 11, Siemionow, K and Lieberman, IH. Vertebral Augmentation in Osteoporotic and Osteolytic Fractures. Current Opinion in Supportive and Palliative Care Sept 3: accessed Sept. 11, Lovi A, Teli M, Ortolina A, et al. Vertebroplasty and Kyphoplasty: Complementary Techniques for the Treatment of Painful Osteoporotic Vertebral Compression Fractures. A Prospective Non-randomised Study on 154 Patients Eur Spine Jour (2009) 18 (Suppl 1):S95-S Passias PG, Li Gang, Wood, KB. SRS Position Paper: The Results of Vertebral Augmentation Procedures Department of Orthopaedic Spine Surgery Massachusetts General Hospital and Harvard Medical School Boston, MA Sept. 8, Lavelle W, Carl A, Lavelle ED, Khaleel MA. Vertebroplasty and Kyphoplasty, Anesthesiol Clin Dec;25 (4): McKiernan F, Faciszewski T, Jensen R. Quality Of Life Following Vertebroplasty. J Bone Joint Surg Am Dec;86-A(12): The Worldwide Orthopaedic Market. Prepared by Knowledge Enterprises. October 2005, p Orthopaedic Industry Annual Report: Orthoworld, Inc. 2009, p Kochan, J. Vertebroplasty and Kyphoplasty, Percutaneous. overview Accessed September 1, Wardlaw, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P,Talmadge K, Boonen S. Efficacy and Safety of Balloon Kyphoplasty Compared with Non-surgical Care for Vertebral Compression Fracture (FREE): a Randomized Controlled Trial Published online February 25, 2009 DOI: /S (09) Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position statement on percutaneous vertebral augmentation: A consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 2009; 20:S326 S Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. The Spine Journal 2008; 8: Percutaneous Vertebroplasty and Kyphoplasty Ed. 2 / Editors, John M Mathis, Hervé Deramond, Stephen M. Belkoff. Copyright 2006 by Springer Science+Business Media, Inc., p Bae, H., et al, A Prospective Randomized FDA-IDE Trial Comparing Cortoss to PMMA for Vertebroplasty: A Comparative Effectiveness Research Study with 24-Months Follow-Up. Spine, first published on July 5, 2011 as doi: /BRS.0b013e31822ba50b. 16. The bioactive response of Cortoss has not been assessed in any clinical investigation and the results from laboratory or animal testing may not be predictive of human clinical experience. 17. Deramond H, Wright NT, Belko- SM. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone, Vol 25 (2) 17S-21S Pomrink, et al., Evaluation of the reaction kinetics of Cortoss, a thermoset cortical bone void ller. Biomaterials, 2003, Vol. 24 (6) Cortoss Bone Augmentation Material: Instructions for Use (IFU)) * Information current as of June 2012 This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Knees Trauma & Extremities Joint Preservation Orthobiologics Medical & Surgical Power Tools & Surgical Accessories Image Guided Navigation Endoscopy & Arthroscopy Integrated Communications Beds, Stretchers & EMS Sustainability Solutions Neurotechnology & Spine Craniomaxillofacial Interventional Spine Neurosurgical, Spine & ENT Neurovascular Spinal Implants Stryker SA Cité Centre Grand-Rue Montreux Switzerland t: f: Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, AutoPlex, VertePort, VertaPlex, SpinePlex, ivas, PCD. All other trademarks are trademarks of their respective owners or holders. The products listed above are CE marked according to the Medical Device Directive 93/42/EEC. Literature Number: MTX Rev C MTX/GS 06/12 Copyright 2012 Stryker

Cortoss Bone Augmentation Material. Surgical Technique Guide

Cortoss Bone Augmentation Material Surgical Technique Guide Table of Contents System Overview... 1 Cortoss Components... 2 Aliquot Components... 3 Preparing Cortoss... 4, 5 Preparing the Vertebral Body...