Norian Drillable: A Competitive Analysis
|
|
- Elizabeth Hoover
- 5 years ago
- Views:
Transcription
1 : A Competitive Analysis Evan Jacobson, M.S. ABSTRACT This study demonstrates the functional properties of and other currently marketed calcium phosphate cements. The functional properties of are similar to the other products when evaluating the compressive strength, setting time, and injectability. The material s toughness* is the property that distinguishes from other products. is 2 3 times tougher than other calcium phosphate cements, which allows for the product to be drilled, tapped, and have a screw placed through it. INTRODUCTION Overview is a biocompatible, fiber reinforced calcium phosphate bone void filler that is intended to be placed into bony voids either before or after final fixation. When fully set, it closely approximates the mineral phase of bone. is made of three key components: calcium phosphate powder, polylactide/glycolide copolymer fibers, and sodium hyalu ronate solution. The calcium phosphate converts in vivo to form carbonated apatite, closely resembling the mineral phase of bone. It is gradually resorbed and replaced with bone during the natural healing process. Calcium phosphate has been widely used in clinical applications for decades, resulting in the availability of many publications and clinically demonstrating its safety and efficacy to address bone regeneration. 1 The bioresorbable polylactide/ glycolide copolymer fibers are uniformly distributed and randomly oriented within the material, providing an increase in toughness which reduces crack propagation and allows for the material to be drilled and tapped. Finally, the sodium hyaluronate solution is a ph-neutral solution that increases viscosity, leading to improved mixing and flow properties. INDICATIONS is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. is intended to be placed in bony voids either before or after final fixation. *Toughness is defined as a measure of a material's resistance to fracture when stressed. Data on file with Synthes.
2 CONTRAINDICATIONS The safety and effectiveness of this device for use in the spine has not been established Use of this device is contraindicated in the spine, including use in the pedicle, as this could be associated with leakage of the device material into the bloodstream, which could cause serious adverse events, including death is not intended for use in the spine and should not be used in the presence of active or suspected infection is not for screw augmentation is not for use in: Patients with traumatic open injuries that are predisposed to infection Stress bearing applications Areas where adjacent bone is avascular, or is incapable of supporting or anchoring the implanted rigid fixation hardware Patients with compromised health (e.g. abnormal calcium metabolism, metabolic bone disease, a recent local untreated infection, vascular or severe neurological disease, infection, immunologic deficiencies or systemic disorders) that result in poor wound healing or will result in tissue deterioration over the implant site Patients who are skeletally immature Vertebral compression fractures Intra-articular space (i.e. material injected into the joint space) Please refer to the instructions for use for a complete list of indications, contra indications, warnings and precautions. STUDY OBJECTIVES & METHODS This study characterized the mechanical properties of, Fast Set Putty (FSP),, Fast Set Putty (FSP), and Stryker. There were four (4) tests that were performed to characterize the products: Compression Test* Indentation Test (Setting time)* ion Test* Three Point Bend Test* COMPRESSION TEST A compression test measures the compressive strength of a material. The compressive strength is the capacity of a material to withstand direct axial compressive loading/forces. In this test, a load is imparted on the material until it fails. The compressive strength (stress) is calculated by dividing the maximum compressive load by the cross-sectional area of the sample. Each material was prepared to create compression cylinders. These samples were cured in 37 C phosphate buffered saline (PBS) for 24 hours and tested to measure the compressive strength. Three dies of each material were prepared for a total of 21 samples. *Mechanical test results are not necessarily indicative of clinical performance. Data on file with Synthes.
3 IDENTATION TEST (SETTING TIME) To establish the setting time of these materials, a sample is prepared and at predetermined time points, the load imparted on the sample is measured. The material is considered set when it achieves either 3 lbf (hand mixed materials) or 9 lbf (machine mixed materials). Each material was prepared to create cylindrical samples. These samples were cured in 37 C PBS (time dependant on product s literature) and then the compressive load was measured. Three mixes were prepared for a total of 9 samples. The time points are as follows: : 8 1 minutes FSP: 3 5 minutes : 8 1 minutes FSP: 3 5 minutes : 3 5 minutes INJECTION TEST This test was conducted on those materials that are stated to be injectable (,, ). The injection force is important to the ergonomics of injectable implants. Elevated injection forces may make it difficult to successfully implant the biomaterial. Previous internal studies have demonstrated that a load exceeding 25 lbf is difficult to manually inject. Each material was mixed and loaded into the Delivery Syringe. A 12 gauge, 1 cm delivery needle was then attached to the delivery needle. Testing was conducted after the dwell time listed below. : 5 minutes post mix : 5 minutes post mix : 4 minutes from start of mixing THREE POINT BEND TEST A three point bend test measures the flexural strength of a material. From the flexural test, the material s toughness can also be established. Work of fracture is a quantitative way of expressing a material s toughness, or the ability of a material to resist crack propagation. To determine the work of fracture, a stress-strain curve is generated during the three point bend test. From this curve, the material s toughness or work of fracture can be calculated by integrating the curve and dividing it by the cross-sectional area of the sample. Each of the materials were prepared to create a rectangular block. These samples were cured for 24 hours and tested to measure the work of fracture. Three molds were prepared for a total of 18 samples.
4 RESULTS Compression Test Each product was filled into three compression dies making 21 individual samples. The average compressive strength ranged from a minimum of MPa ( FSP) to a maximum of MPa ( Rotary Mix) (Figure 1). FSP,, and had average compressive strengths of MPa, MPa, and 26.3 MPa, respectively, which are all clinically similar. 6 Comp. Stress (MPa) FSP FSP Figure 1. Compression Test Indentation Testing (Setting Time) The indentation test evaluates the compressive load at the identified setting time of a material. Three mixes from each of the materials were evaluated at three time points defined as the set time in the product literature. FSP, FSP and were all evaluated between 3 and 5 minutes in 37 C PBS. The average loads at this time for FSP, FSP and were lbf, 86.6 lbf, and lbf, respectively (Figure 2). 25 Comp. Load at.5 in (lbf) FSP FSP Figure 2. Indentation Test
5 These three materials would meet the acceptance criterion of 3 lbf at 5 minutes for FSP and are all clinically similar. and were measured at 1 minutes which is identified as the set time. had a load of lbf, whereas had a load of lbf, both of which met the acceptance criterion ( 9 lbf). ion Test The injection test evaluated the maximum load required to deliver the material from the syringe. The first analysis evaluating the peak load demonstrated that and require similar loads to inject the materials out a syringe, ranging from lbf ( ) to lbf ( ) (Figure 3). At bf required to inject, was more than 2x higher than and. All materials were measured in triplicate within the working time defined in the product s literature Peak Load (lbf) Figure 3. ion Test Three Point Bend Test Each product was filled into three molds making 18 individual samples. The average work of fracture ranged from a minimum of J/m2 ( FSP) to a maximum of J/m2 ( ) (Figure 4). 7 Work of Fracture (J/m 2 ) FSP FSP Figure 4. Three Point Bend Test
6 , FSP and were all clinically similar with average work of fractures of J/m2, J/m2, and J/m2, respectively. The products had a magnitude higher work of fracture compared to the other products, 41.5 J/m2 ( FSP) and J/m2 ( ). There is a magnitude difference in the range, which is directly related to the toughness of the materials (Figure 5). Ceramic materials are brittle in flexural loading, but the added fibers in FRN increase the toughness compared to other ceramics.,, Stryker (Stryker) Stress (MPa) Strain (mm) Figure 5. Comparison of Material Toughness CONCLUSIONS The functional testing demonstrated that although the five products have some similar characteristics, there are distinct differences between the products. The compressive strength of and were higher than the other three devices that are mixed by hand. All products were found to be higher than cancellous bone (~5 7 MPa) 2. The setting time test showed at the time defined in the product literature, all of the materials met the standards for setting. All other products were set between 5 and 1 minutes in 37 C PBS. For ergonomic reasons, the amount of load required to inject the material out of syringe should be minimized as much as possible. and required similar loads to inject the material, but required more than 2 times those loads. The three point bend test displayed the largest difference between the products and the other ceramics. The average work of fracture of the products was 2 3 times higher than the other products. This increase demonstrated that the products have a higher material toughness and an increased ability to resist cracking.
7 References 1. Bajammal S, Zlowodzki M, Lelwica A, Tornetta P III, Einhorn T, Buckley R, Leighton R, Russell T, Larsson S, Bhandari M. The Use of Calcium Phosphate Bone Cement in Fracture Treatment. A Meta-Analysis of Randomized Trials. Journal of Bone and Joint Surgery 28; 9: Cowin, S.C., ed. Bone Mechanics Handbook. 2nd ed. New York, NY: CRC Press, Print. 212 Synthes, Inc. or its affiliates. All rights reserved. Stryker and are trademarks of Stryker Corporation or its affiliates. is a trademark of Kensey Nash or its affiliates. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/12 J11497-A
Drillable Fast Set Putty
Norian Drillable Fast Set Putty Fiber reinforced calcium phosphate bone void filler Surgical Technique Indications and Contraindications* Indications Norian Drillable Fast Set Putty is intended for bony
More informationDrillable. Fiber reinforced calcium phosphate bone void filler. Surgical Technique
Norian Drillable Inject Fiber reinforced calcium phosphate bone void filler Surgical Technique Indications and Contraindications* Indications Norian Drillable Inject is intended for bony voids or defects
More informationCalcium Phosphate Bone Void Filler TECHNIQUE GUIDE
Calcium Phosphate Bone Void Filler TECHNIQUE GUIDE Features Easily shaped and molded for implantation into defects positioned at difficult angles Hardens in a warm, wet environment, reducing the need to
More informationCRANIAL RECONSTRUCTION SOLUTIONS
CRANIAL RECONSTRUCTION SOLUTIONS CRANIAL RECONSTRUCTION SOLUTIONS Your partner of CHOiCE at depuy Synthes CMF, we are dedicated to providing solutions for your individual patient needs. We do this through
More informationTechnique Guide. Cranios Reinforced Rotary Mix. The tougher bone cement.
Technique Guide Cranios Reinforced Rotary Mix. The tougher bone cement. Table of Contents Introduction Cranios Reinforced Rotary Mix 2 Basic Science 4 Indications and Contraindications 5 Surgical Technique
More informationPRO-DENSE BONE GRAFT SUBSTITUTE
PRO-DENSE BONE GRAFT SUBSTITUTE 152917-0 The following languages are included in this packet: For additional languages, visit our website www.wright.com. Then click on the option. For additional information
More informationPRO-DENSE Bone Graft Substitute The following languages are included in this packet:
EN PRO-DENSE Bone Graft Substitute 133486-11 The following languages are included in this packet: English (en) For additional languages, visit our website www.wmt.com Then click on the Prescribing Information
More informationCallos Bone Void Filler
Surgical Technique Callos Bone Void Filler Acumed is a global leader of innovative orthopaedic and medical solutions. We are dedicated to developing products, service methods, and approaches that improve
More informationADVANCED BONE GRAFT SYSTEM OVERVIEW
ADVANCED BONE GRAFT SYSTEM OVERVIEW NANOSS BIOACTIVE ADVANCED BONE GRAFT Table Of Contents INTRODUCTION System Overview... 1 NANOSS BIOACTIVE COMPONENTS Comparison of nanoss Bioactive and Human Bone...
More informationSurgical Technique Guide. Impact & Inject Formulations
Surgical Technique Guide Impact & Inject Formulations System Overview OsteoVation QWIK is a bone void filler consisting of a proprietary composite of calcium phosphate and calcium sulfate granules. The
More informationCELLPLEX TCP SYNTHETIC CANCELLOUS BONE
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE 129257-9 The following languages are included in this packet: English (en) Deutsch (de) Nederlands (nl) Français (fr) Español (es) Italiano (it) Português (pt) -
More informationchronos Bone Void Filler. Beta-Tricalcium Phosphate ( β-tcp) bone graft substitute.
chronos Bone Void Filler. Beta-Tricalcium Phosphate ( β-tcp) bone graft substitute. Osteoconductive Resorbable Synthetic chronos Bone Void Filler chronos granules and preforms are synthetic, porous, osteoconductive,
More informationPRELIMINARY RESULTS OF A NEW INJECTABLE AND DRILLABLE BONE VOID FILLER IN THE TREATMENT OF TIBIA PLATEAU FRACTURES A First Case Review
PRELIMINARY RESULTS OF A NEW INJECTABLE AND DRILLABLE BONE VOID FILLER IN THE TREATMENT OF TIBIA PLATEAU FRACTURES A First Case Review S. Hem, MD, 1 P. Ström, MD, 2 J. de la Heras, MD, 3 P. Wittich, 4
More informationCalcium Phosphate Cement
Calcium Phosphate Cement Fast-Setting Bone Graft and AutoGraft Extender. * Ossilix is a high performance next generation calcium phosphate cement indicated for filling bony defects in cancellous bone.
More informationBiomaterials Line. MIS Corporation. All Rights Reserved.
7. Biomaterials Line MIS Corporation. All Rights Reserved. 6. MIS s Quality System complies with international quality standards: ISO 13485: 2003 - Quality Management System for Medical Devices, ISO 9001:
More informationAsnis. Micro Cannulated screw system. Xpress operative technique
Asnis Micro Cannulated screw system Xpress operative technique Asnis Micro Cannulated screw system Table of contents Indications, precautions & contraindications 3 Operative technique 4 This publication
More informationDentoalveolar Bone Fixation System. Bone fixation sets for the office.
Dentoalveolar Bone Fixation System. Bone fixation sets for the office. Compact Modular Customized Dentoalveolar Bone Fixation System. Bone fixation sets for the office. Who we are Synthes is a global medical
More informationHoffmann II Micro External Fixation System. Indications for the Hand
Hoffmann II Micro External Fixation System Indications for the Hand Features & Benefits The instrumentation is Simple and User-Friendly, and the system is Color Coded, so there is no lost time or confusion
More informationVertoCure. Reference Guide. VCF Treatment System. zimmer.com
VertoCure VCF Treatment System Reference Guide zimmer.com VertoCure VCF Treatment System The system VertoCure is indicated in the treatment of Vertebral Compression Fractures (VCF) by vertebroplasty. With
More informationBone Void Filler. Callos. The Next Generation in Calcium Phosphate Cement A COLSON ASSOCIATE
Callos Bone Void Filler The Next Generation in Calcium Phosphate Cement A COLSON ASSOCIATE Callos Calcium Phosphate Cement Callos is a high performance next generation calcium phosphate cement indicated
More informationOssiMend Bone Graft Matrix
OssiMend All-Natural Mineral-Collagen Bone Grafting Matrix Anorganic bone mineral and type I collagen Highly purified, biocompatible matrix Osteoconductive Osteoinductive and Osteogenic in conjunction
More informationMASTERGRAFT Putty. Technical Guide
MASTERGRAFT Putty Technical Guide MASTERGRAFT Putty is a malleable-cohesive, osteoconductive scaffold composed of collagen that is physically mixed with resorbable ceramic granules. Mixing Process Collagen
More informationPOSTERIOR LUMBAR FUSION SURGICAL TECHNIQUE USING A BONE VOID FILLER. Magnifuse. Bone Graft
POSTERIOR LUMBAR FUSION SURGICAL TECHNIQUE USING A BONE VOID FILLER Magnifuse Bone Graft PREPARATION INSTRUCTIONS Soft tissue should be completely removed from the posterior elements of the spinal segments
More informationThe following languages are included in this packet:
OSTEOSET XR BONE VOID FILLER 150841-0 The following languages are included in this packet: English (en) Deutsch (de) Nederlands (nl) Français (fr) Español (es) Italiano (it) Português (pt) 中文 - Chinese
More informationTRABECULAR METAL ACETABULAR RESTRICTOR AND AUGMENT. Surgical Technique
TRABECULAR METAL ACETABULAR RESTRICTOR AND AUGMENT Surgical Technique ACETABULAR ASSESSMENT AND PREPARATION Intra-operatively, carefully assess any acetabular bone defects present. Note the location, extent,
More informationTechnique Guide. chronos Strip. Osteoconductive betatricalcium phosphate ( -TCP) composite.
Technique Guide chronos Strip. Osteoconductive betatricalcium phosphate ( -TCP) composite. Table of Contents Introduction chronos Strip 2 Indications and Contraindications 3 Surgical Technique Preparation
More informationBio XT Maximising the Material Performance of Resorbable Implants
Bio XT Maximising the Material Performance of Resorbable Implants OMTEC, 17 th June 2015 What is Bio XT? Bio XT is a proprietary biomaterials processing technology Alternative to injection moulding or
More informationchronos Inject. Synthetic Bone Substitute Injectable, Osteoconductive, Resorbable.
chronos Inject. Synthetic Bone Substitute Injectable, Osteoconductive, Resorbable. Technique Guide The answer to bone voids Table of contents Introduction 2 Case Study 3 Indications and Contraindications
More informationTrabecular Metal Acetabular Restrictor and Augment
Trabecular Metal Acetabular Restrictor and Augment Surgical Technique The Best Thing Next To Bone Trabecular Metal Acetabular Restrictor and Augment Acetabular Assessment and Preparation Intra-operatively,
More informationBONE void FILLER. Beta-tricalcium phosphate ( b-tcp) bone graft substitute. OvERvIEW BROCHURE
chronos BONE void FILLER Beta-tricalcium phosphate ( b-tcp) bone graft substitute OvERvIEW BROCHURE chronos STRIP chronos Strip is a synthetic bone void filler manufactured from chronos Beta-Tricalcium
More informationTrabecular Metal Acetabular Restrictor and Augment
Trabecular Metal Acetabular Restrictor and Augment Surgical Technique The Best Thing Next To Bone Trabecular Metal Acetabular Restrictor and Augment Acetabular Assessment and Preparation Intra-operatively,
More informationPERFORATED CLICK X Augmentable pedicle screws for osteoporotic bone
PERFORATED CLICK X Augmentable pedicle screws for osteoporotic bone Instruments and implants approved by the AO Foundation. This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE
More informationCobalt. MV Bone Cement
Featuring Patented SoftPac Technology Cobalt offers surgeons the choice of a medium viscosity cementing solution that provides premium product benefits such as patented SoftPac technology, high contrast
More informationAxSOS Locking Plate System
AxSOS Locking Plate System Operative Technique Proximal Lateral Tibia 1 2 Contents Page 1. Introduction 4 2. Features & Benefits 5 3. Relative Indications & Contraindications 6 4. General Guidelines 7
More informationControl. Control Through VISCOSITY Control Through DELIVERY Control Through SIMPLICITY
Control. Now that s CONFIDENCE. Control Through VISCOSITY Control Through DELIVERY Control Through SIMPLICITY Control throughviscosity Controlled Fill Cement Interdigitation Low viscosity cement Trabecular
More informationLocking Plate System. Operative Technique. Distal Anterolateral Tibia Distal Medial Tibia
AxSOS Locking Plate System Operative Technique Distal Anterolateral Tibia Distal Medial Tibia 1 Introduction The AxSOS Locking Plate System is designed to treat periarticular or intra-articular fractures
More informationAxSOS Locking Plate System
AxSOS Locking Plate System Operative Technique Distal Anterolateral Tibia Distal Medial Tibia 1 Introduction The AxSOS Locking Plate System is designed to treat periarticular or intra-articular fractures
More informationLawrence A. DiDomenico, DPM, FACFAS
Lawrence A. DiDomenico, DPM, FACFAS Adjunct Professor, Kent State University College of Podiatric Medicine, Cleveland, Ohio USA Director, Reconstructive Rearfoot & Ankle Surgical Fellowship, Ankle and
More informationAugmentable Pedicle Screws for Osteoporotic Bone. Perforated Click X. Surgical Technique
Augmentable Pedicle Screws for Osteoporotic Bone Perforated Click X Surgical Technique Image intensifier control This description alone does not provide sufficient background for direct use of DePuy Synthes
More informationBioactive Glass Biphasic β-tcp & HA Granules Alkylene Oxide Polymer Carrier. MEDLINEUNITE Bioactive Bone Graft
Bioactive Glass Biphasic β-tcp & HA Granules Alkylene Oxide Polymer Carrier Principles of Bone Healing Reparative Phase Healing Cascade 1. Cellular infiltration and migration to site (fibroblasts, macrophages,
More informationHydroSet. Fast-setting HA bone substitute
HydroSet Fast-setting HA bone substitute Features The HydroSet material is formulated to harden in a wet field environment. Fast-setting Excellent wet-field properties Injectable or manual implantation
More informationIndications. Neuro Surgery. Plastic Surgery. ENT Surgery. Oral Maxillofacial Surgery
Indications Neuro Surgery Cranioplasty/Craniectomy Bur Hole Filling Cranial Cuts Onlay & Inlay grafting Plastic Surgery Cranial Reconstruction Orbital Reconstruction Onlay Grafting ENT Surgery Frontal
More informationRAPIDSORB RAPID RESORBABLE FIXATION SYSTEM. A new resorbable approach to Alveolar bone augmentation
RAPIDSORB RAPID RESORBABLE FIXATION SYSTEM A new resorbable approach to Alveolar bone augmentation RAPIDSORB RAPID RESORBABLE FIXATION SYSTEM Bone Graft Containment The RapidSorb Rapid Resorbable Fixation
More informationGraftys. Cross-selling. Indications. Comparison. Basic Science. Graftys 415 rue Claude Nicolas Ledoux Aix en Provence Cedex 4
2015 Graftys Cross-selling Indications Comparison Graftys 415 rue Claude Nicolas Ledoux 13854 Aix en Provence Cedex 4 www.graftys.com Basic Science Graftys QuickSet Training 1 Where to use QuickSet? Revision
More informationAxSOS Locking Plate System
AxSOS Locking Plate System Operative Technique Small Fragment Basic Fragment 1 2 Contents Page 1. Introduction 4 2. Features & Benefits 5 4 and 5mm Compression Plates 5 Reconstruction and 1/3 Tubular Locking
More informationCalcium Phosphate Cement Augmentation of the Femoral Neck Defect Created After Dynamic Hip Screw Removal
ORIGINAL ARTICLE Calcium Phosphate Cement Augmentation of the Femoral Neck Defect Created After Dynamic Hip Screw Removal Eric J. Strauss, MD, Brian Pahk, BA, Frederick J. Kummer, PhD, and Kenneth Egol,
More informationTechnique Guide. 3.5 mm LCP Proximal Tibia Plate. Part of the Synthes Small Fragment LCP System.
Technique Guide 3.5 mm LCP Proximal Tibia Plate. Part of the Synthes Small Fragment LCP System. Table of Contents AO ASIF Principles of Internal Fixation 4 Indications/Contraindications 5 Surgical Technique
More informationRapidSorb Resorbable Tacks. Resorbable Fixation System.
RapidSorb Resorbable Tacks. Resorbable Fixation System. Fast Safe Resorbable Drill Press Fixed Table of Contents Introduction Overview 2 Indications and Contraindications 4 RapidSorb 5 Surgical Technique
More informationCarpal Tunnel Ligament Release
Shoulder AxSOS KnifeLight Locking Plate System Carpal Tunnel Ligament Release Operative Technique Operative Technique Proximal Humerus Alternating threaded shaft holes Humerus This publication sets forth
More informationLow Profile Neuro Plating System. Surgical Technique
Low Profile Neuro Plating System Surgical Technique TABLE OF CONTENTS INTRODUCTION Low Profile Neuro Plating System 2 SURGICAL TECHNIQUE Technique 5 PRODUCT INFORMATION Low Profile Neuro Plates 10 Low
More informationLCP Medial Distal Tibia Plate, without Tab. The Low Profile Anatomic Fixation System with Angular Stability and Optimal Screw Orientation.
LCP Medial Distal Tibia Plate, without Tab. The Low Profile Anatomic Fixation System with Angular Stability and Optimal Screw Orientation. Technique Guide LCP Small Fragment System Table of Contents Introduction
More informationThe injectable, self-setting calcium phosphate bone graft substitute.
The injectable, self-setting calcium phosphate bone graft substitute. With a porous architecture similar to natural bone. STRUCSURE CP Bone Graft Substitute Because simplicity matters STRUCSURE CP Bone
More informationIntegra. ADVANSYS Plating System SURGICAL TECHNIQUE
Integra ADVANSYS Plating System SURGICAL TECHNIQUE Table of Contents Dorsal Lisfranc Plate Indications...2 Contraindications...2 Description...2 Surgical Technique...3 Surgical Site Preparation...3 Step
More informationCarpal Tunnel Ligament Release
Tibia & Fibula AxSOS KnifeLight Locking Plate System Carpal Tunnel Ligament Release Operative Technique Tibia Fractures Operative Technique Distal Anterolateral Tibia Distal Medial Tibia Alternating threaded
More informationCASE STUDY: PRO-DENSE Injectable Regenerative Graft Used to Backfill a Bone Cavity Following Resection of a Giant Cell Tumor
: PRO-DENSE Used to Backfill a Bone Cavity Following Resection of a Giant Cell Tumor Contributed by: Matthew J. Seidel, MD* Lauren A. Schwartz, NP Scottsdale, AZ *Dr. Seidel is a paid consultant for Wright
More informationlow ProfIle neuro PlaTIng system
low ProfIle neuro PlaTIng system surgical TeChnIque Table of Contents Introduction Low Profile Neuro Cranial Plating System 2 Surgical Technique Technique 5 Product Information Low Profile Neuro Plates
More informationAxSOS. Locking Plate System. Operative Technique. Small Fragment Basic Fragment
AxSOS Locking Plate System Operative Technique Small Fragment Basic Fragment Stryker Plating Contents Page 1. Introduction 4 2. Features & Benefits 5 4 and 5 Compression Plates 5 Reconstruction and 1/3
More informationInion BioRestore. Bone Graft Substitute. Product Overview
Inion BioRestore Bone Graft Substitute Product Overview Inion BioRestore Introduction Inion BioRestore is a synthetic bone graft substitute, which remodels into bone and is easy to use. Inion BioRestore
More informationVertebral compression model and comparison of augmentation agents
23 23 27 Vertebral compression model and comparison of augmentation agents Authors Clint Hill, Scott Wingerter, Doug Parsell, Robert McGuire Institution Department of Orthopedic Surgery and Rehabilitation,
More informationFlexible Fragment Fixation. Surgical Technique
Flexible Fragment Fixation Surgical Technique 2 F 3 Flexible Fragment Fixation The F 3 Fragment Plating System offers low profile, yet strong fixation in a locked plating construct that can be contoured
More informationTechnique Guide. 3.5 mm LCP Low Bend Medial Distal Tibia Plates. Part of the Synthes locking compression plate (LCP) system.
Technique Guide 3.5 mm LCP Low Bend Medial Distal Tibia Plates. Part of the Synthes locking compression plate (LCP) system. Table of Contents Introduction 3.5 mm LCP Low Bend Medial Distal Tibia Plates
More informationTechnique Guide. Locking Attachment Plate. For treatment of periprosthetic fractures.
Technique Guide Locking Attachment Plate. For treatment of periprosthetic fractures. Table of Contents Introduction Locking Attachment Plate 2 Indications 4 Surgical Technique Patient Positioning 5 Preparation
More informationClinical. Solutions. Synthes Solutions. Foot and Ankle.
Clinical Solutions Foot and Ankle. Foot and Ankle. Fractures of the tibial shaft Fractures of the distal fibula Fractures of the distal tibia Fractures and osteotomies of the calcaneus Arthrodesis Fractures,
More informationVariAx Compression Plating System. Operative technique
VariAx Compression Plating System Operative technique VariAx Compression Plating System Operative technique VariAx Compression Plating System Contents 1. Introduction... 3 2. Indications, MR safety information
More informationProduct Information. MIS Corporation. All Rights Reserved.
Product Information MIS Corporation. All Rights Reserved. MIS Warranty: MIS exercises great care and effort in maintaining the superior quality of its products. All MIS products are guaranteed to be free
More informationComparative Animal Study of OssiMend and Healos 13,14
Comparative Animal Study of OssiMend and Healos 13,14 Objective This study was conducted to evaluate the use of OssiMend as compared with Healos in combination with autologous bone marrow as a bone grafting
More information2.4 mm Variable Angle LCP Volar Extra-Articular Distal Radius System. For fragment-specific fracture fixation with variable angle locking technology.
Technique Guide 2.4 mm Variable Angle LCP Volar Extra-Articular Distal Radius System. For fragment-specific fracture fixation with variable angle locking technology. Table of Contents Introduction 2.4
More informationPFNA. With Augmentation Option.
PFNA. With Augmentation Option. Superior anchor in osteoporotic bone Simple and reproducible procedure through standardized technique Intraoperative decision for augmentation PFNA. Proximal Femoral Nail
More informationStep-by-Step Step-by-Step. Internal Hex. Implant System MAKE IT SIMLE
4. 7. Step-by-Step Cemented Step-by-Step Bridge BONDBONE Using Abutments Internal Hex. Implant System MAKE IT SIMLE MIS Corporation. All Rights Reserved. Published by MIS, which reserves the right to ameliorate
More informationCranial idtm. Cranial restoration. id SolutionsTM. Individually designed. Personalized care.
Cranial idtm Cranial restoration id SolutionsTM Individually designed. Personalized care. id Solutions Individually designed cranial implants for the restoration of cranial defects. Our id Solutions, Cranial
More informationCortoss 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...
More informationSurgical Technique Guide
Surgical Technique Guide Flow-FX, LLC - 815.531.4424-9110 Darvin Drive, Mokena, IL 60448 - www.flow-fx.net Contents Implant Overview 1 Implant Features and Benefits 2 Instrument Overview 3 Surgical Technique
More informationLCP Distal Tibia Plate
Surgical Technique LCP Locking Compression Plate Original Instruments and Implants of the Association for the Study of Internal Fixation AO/ASIF Table of contents Indications 3 Implants/Instruments 5 Surgical
More informationSynex System TECHNIQUE GUIDE. An expandable vertebral body replacement device
Synex System TECHNIQUE GUIDE An expandable vertebral body replacement device Original Instruments and Implants of the Association for the Study of Internal Fixation AO ASIF Synex System Overview The Synex
More informationB U I L D S T R O N G B O N E F A S T
B U I L D S T R O N G B O N E F A S T Putty MIS Particulate Morsels A BIOACTIVE SYNTHETIC BONE FOR FASTER HEALING NovaBone is a 100% bioactive synthetic material composed from elements that occur naturally
More informationTissueMend. Arthroscopic Surgical Technique. Arthroscopic Insertion of a Biologic Rotator Cuff Tissue Augment After Rotator Cuff Repair
TissueMend Arthroscopic Surgical Technique Arthroscopic Insertion of a Biologic Rotator Cuff Tissue Augment After Rotator Cuff Repair Table of Contents Placement of suture anchors Placement of anteromedial
More informationSMV Scientific Bone Plate and Screw System Surgical Technique
SMV Scientific Bone Plate and Screw System Surgical Technique Description: The SMV Scientific Bone Plate and Screw System consists of non-locking plates and bone screw fasteners in a variety of lengths,
More informationTechnique Guide KISSloc Suture System
Technique Guide KISSloc Suture System The KISSloc Suture System consists of a strong self-cinching suture assembly, a unique load-dispersing Arrow Plate and procedure specific instrumentation. Simple,
More informationchronos STRIP Bone Void Filler
chronos STRIP Bone Void Filler Osteoconductive beta-tricalcium phosphate (b-tcp) composite This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE TABLE OF CONTENTS INTRODUCTION
More informationSURGICAL TECHNIQUE. Protrusio Cage A COMPREHENSIVE ACETABULAR REVISION SYSTEM
SURGICAL TECHNIQUE Protrusio Cage A COMPREHENSIVE ACETABULAR REVISION SYSTEM Important: This essential product information does not include all of the information necessary for selection and use of a device.
More informationInnovative Range of Regenerative Solutions
TM Innovative Range of Regenerative Solutions MIS Implant Technologies Ltd. All rights reserved. Optimal volumes and quality of hard and soft tissue are required to satisfy the goals of oral rehabilitation
More informationAUGMENT. Bone Graft. Tibiotalar Fusion. rhpdgf-bb/β-tcp THE FIRST AND ONLY PROVEN ALTERNATIVE TO AUTOGRAFT IN ANKLE AND HINDFOOT ARTHRODESIS
rhpdgf-bb/β-tcp AUGMENT Bone Graft THE FIRST AND ONLY PROVEN ALTERNATIVE TO AUTOGRAFT IN ANKLE AND HINDFOOT ARTHRODESIS CASE REPORT Tibiotalar Fusion as presented by Mark Glazebrook, MD Assoc Professor
More informationZimmer Small Fragment Universal Locking System. Surgical Technique
Zimmer Small Fragment Universal Locking System Surgical Technique Zimmer Small Fragment Universal Locking System 1 Zimmer Small Fragment Universal Locking System Surgical Technique Table of Contents Introduction
More informationTrephine System. Principle-based anterior lumbar interbody fusion.
Trephine System. Principle-based anterior lumbar interbody fusion. Technique Guide Instruments and implants approved by the AO Foundation Table of Contents Introduction Trephine System 2 AO Principles
More informationGene Activation for Excellent Bone Remodeling
Osteostimulative bone regeneration granules Gene Activation for Excellent Bone Remodeling Injectable Putty Granules BIOMATERIALS STIMULATING THE BONE REGENERATION Noraker has been involved in biomaterial
More informationCarpal Tunnel Ligament Release
Femur AxSOS KnifeLight Locking Plate System Carpal Tunnel Ligament Release Operative Technique Femur Fractures Operative Technique Distal Lateral Femur Alternating threaded shaft holes This publication
More informationOBSOLETED. LCP Medial Distal Tibia Plate, without Tab. The Low Profile Anatomic Fixation System with Angular Stability and Optimal Screw Orientation.
LCP Medial Distal Tibia Plate, without Tab. The Low Profile Anatomic Fixation System with Angular Stability and Optimal Screw Orientation. Surgical Technique LCP Small Fragment System This publication
More informationTechnique Guide. Orthodontic Bone Anchor (OBA) System. Skeletal implants for the orthodontic movement of the teeth.
Technique Guide Orthodontic Bone Anchor (OBA) System. Skeletal implants for the orthodontic movement of the teeth. Table of Contents Introduction Orthodontic Bone Anchor (OBA) System 2 Indications and
More informationProduct Highlights. TRUREPAIR Solutions
TRUREPAIR Solutions Product Highlights TTRUREPAIR Solutions...T-1 TRUREPAIR Solutions Smith & Nephew TRUREPAIR devices provide a resorbable scaffold and related instrumentation for the repair and replacement
More informationUser FAQ Graftys QuickSet & HBS
User FAQ QuickSet & HBS Where can I buy product? 2 Is the product FDA cleared or CE marked? 2 What is shelf life for HBS or QuickSet? 2 How do I prepare HBS or Quickset? 2 How should I mix QuickSet and
More informationVIPER Cortical Fix Fenestrated Screw System. Surgical Technique for OPEN & MIS Procedures
VIPER Cortical Fix Fenestrated Screw System Surgical Technique for OPEN & MIS Procedures Image intensifier control This description alone does not provide sufficient background for direct use of DePuy
More informationDistal Radius Plate 2.4/2.7 dorsal and volar
Distal Radius Plate 2.4/2.7 dorsal and volar Surgical Technique This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation. Distal Radius Plate
More informationLOWER EXTREMITIES SINGLE-USE INSTRUMENTATION SURGICAL IMPLANTATION TECHNIQUE. First Metatarsal Phalangeal Joint FOOT THE DIFFERENCE IS MOVING.
LOWER EXTREMITIES SINGLE-USE INSTRUMENTATION SURGICAL IMPLANTATION TECHNIQUE First Metatarsal Phalangeal Joint FOOT THE DIFFERENCE IS MOVING. CARTIVA SYNTHETIC CARTILAGE IMPLANT SURGICAL IMPLANTATION TECHNIQUE
More informationLCP Low Bend Medial Distal Tibia Plates 3.5 mm. Anatomic plates with low profile head for intra- and extraarticular fractures.
LCP Low Bend Medial Distal Tibia Plates 3.5 mm. Anatomic plates with low profile head for intra- and extraarticular fractures. Surgical Technique This publication is not intended for distribution in the
More information3.5 mm Locking Attachment Plate
For Treatment of Periprosthetic Fractures 3.5 mm Locking Attachment Plate Surgical Technique Table of Contents Introduction 3.5 mm Locking Attachment Plate 2 Indications 4 Surgical Technique Preparation
More informationMore than bone regeneration. A total solution.
More than bone regeneration. A total solution. More than a dental implant company. A total solution. When it comes to treatment options, your patients want positive results both functionally and esthetically.
More informationRibFix Blu. Thoracic Fixation System
RibFix Blu RibFix Blu Thoracic Fixation System The New Era of Rib Fixation Begins Now Designed by Trauma Surgeons for Trauma Surgeons Your work matters and so do your patients. We are continually engineering
More informationACP. Anterior Cervical Plate System SURGICAL TECHNIQUE
ACP Anterior Cervical Plate System SURGICAL TECHNIQUE ACP TABLE OF CONTENTS INTRODUCTION 4 INDICATIONS AND CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 6 IMPLANT DESCRIPTION 7 INSTRUMENTS 10 SURGICAL
More informationPFNA. With Augmentation Option.
PFNA. With Augmentation Option. Superior anchor in osteoporotic bone Simple and reproducible procedure through standardized technique Intraoperative decision for augmentation This publication is not intended
More informationCarpal Tunnel Ligament Release
Femur AxSOS KnifeLight Targeting System Carpal Tunnel Ligament Release Operative Technique Femur Fractures Operative Technique Distal Lateral Femur Alternating threaded shaft holes This publication sets
More information