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PRODUCT BROCHURE

SKILL,DEDICATION,AND

TM

2 DePuy Synthes Mitek Sports Medicine ENDURANCE Hip Solutions

DELIVERING CONFIDENCE IN HIP ARTHROSCOPY

The number of hip arthroscopy procedures performed in the five years since 2007 more than doubled1 due to growing interest among surgeons in helping to preserve hip health and function within an increasingly aware and active patient population. Advances in technique and technology have evolved hip surgery from an open procedure to an arthroscopic procedure, and have increased the complexity of conditions that can be treated in the central and peripheral compartments as well as the peritrochanteric space. Innovation will undoubtedly continue to advance the treatment of patients with hip pain and injuries.

Mitek Sports Medicine introduces the ENDURANCETM Hip Platform, delivering excellence in arthroscopy to the hip. Whether you are new to hip arthroscopy or experienced in this anatomy, the ENDURANCE Hip Platform provides innovative products, and excellence in education and service – for a comprehensive hip arthroscopy solution. With the ENDURANCE Hip Platform, you can focus with confidence on getting your patients back to their passion.

3ENDURANCE Hip Solutions DePuy Synthes Mitek Sports Medicine

TABLE OF CONTENT

ENDURANCE Hip Solutions Overview 4 - 5

Hip Access 6 - 7

GRYPHON® Anchor Hip System 8 - 9

The Clear Canula System 10

Hip Procedure System 11

The VAPR VUE® System with COOLPULSE® Technology 12

FMS DUO®+ Fluid Management System 13

Hip in a Box 14

Ordering Information 15


Hip Access Kit

• A comprehensive kit that enables confident entry into the hip

• Needles have a robust plastic hub and tip designed to provide sensitive control during insertion

• Nitinol guidewires provide the flexibility you need when entering the hip joint

ENDURANCE HIP SOLUTIONS OVERVIEW

Hip Procedure System

• 190-mm working length

• Curves of varying angles: up, right, and left to reach difficult-to-access areas in the hip

• Tools for the standard procedure and for handling unexpected events

GRYPHON Anchor with Hip Drill Guide

• Anchor available in both BIOCRYL® RAPIDE™ Biocomposite Material and PEEK

• GRYPHON Hip Drill guide, offering extra working length for the hip

• ORTHOCORD® High Strength Orthopaedic Suture with a absorbable polydioxanon (PDS®) component has less mass postoperatively


Clear Cannulas

• Disposable cannulas with disposable obturator (reusable obturator available)

• Available in both 90 mm and 110 mm. The 110-mm length offers access to the deeper hip joint while maintaining visibility of tools

• Combine with DePuy Synthes Mitek Sports Medicine FMS DUO+ Fluid Management System for optimal performance

FMS DUO+ System

• Enables optimal visibility by managing both inflow and outflow

• Reduces risk of extravasation in hip arthroscopy through independent control of pressure and flow

• Simplifies setup and minimizes prep time for greater operating-room efficiency

VAPR VUE RADIOFREQUENCY SYSTEM

• Proprietary COOLPULSE Technology, with unique power pulses, enables 20.4% faster ablation than the leading competitor at equal or lower heat levels2

• Smaller tip size and shaft diameter allow easy access to smaller spaces and greater maneuverability

• Minimal bubbles generated and clogging significantly minimized compared to leading competitor*

*As compared to ARTHROCARE® SUPER TURBOVAC® during in vitro testing2


HIP ACCESS

Multiple Kits to meet the needs of every surgeon.

Offering straight, curved or no blade options, the Hip Access Kit provides the components you need for optimal hip access.

• Multiple needle lengths enable portal placement in all patients

• 16-G nitinol guidewires provide both the flexibility needed inside the acetabulum and the rigidity necessary to maintain trajectory through soft tissues

• Round tip guidewires for less aggressive contact with the cartilage

• The nitinol guidewire is designed to work in seamless partnership with the Mitek Sports Medicine dilation system


Hip Straight Blade

• Sharp every time, allowing you to cut through even the thickest hip capsule3

• Designed to resist breaking when used for a hip capsulotomy4

• At 28 cm, the handle length is ideal for all patient sizes

Hip Curved Blade

• Designed with a 20 degree bend, to mimic the natural contours of the hip

• Offers all of the same features and benefits of the Hip Straight Blade

Blades also available separately

Blades also available separately


ORTHOCORD Suture

• ORTHOCORD Suture is designed to help minimize the amount of suture and knot mass, which could potentially interfere with the labral function in a hip repair

• Partially (62% PD S) absorbable with a reduction of knot profile over time (The PDS component of ORTHOCORD Suture is essentially absorbed between 238 and 294 days post-implantation5.)

• Smaller knot profile with high knot-retention force8

GRYPHON ANCHOR HIP SYSTEM

GRYPHON Anchor Hip System

• Available in both BIOCRYL RAPIDE Biocomposite Material and PEEK

• GRYPHON Anchor Hip Drill guide, offering extra working length for the hip

• Single or double loaded with ORTHOCORD Suture


BIOCRYL RAPIDE BIOCOMPOSITE MATERIAL

BIOCRYL RAPIDE Biocomposite Material is a second-generation composite material consisting of 30% osteoconductive ß-TCP and 70% PLGA. A proprietary microparticle dispersion (MPD) manufacturing process ensures a homogenous dispersion of the composite materials, reducing the incidence of stress risers, and ensuring that osteoconductive ß-TCP is in close apposition with the surrounding bone tissues during the absorption process.9

In long-term human CT imaging studies, BIOCRYL RAPIDE Biocomposite Material appears to be absorbed with observed bony replacement by 36 months.10,11

Long-term CT Images of PLLA vs MILAGRO® BR (ß-TCP/PLGA) Interference Screws11

PLLA• Image taken ~7 years post-op

• Screw appears fully absorbed

• No observed bony replacement in screw profile

ß-TCP/PLGA• Image taken ~3 years post-op

• Screw appears fully absorbed

• Bony replacement in screw profile11


THE CLEAR CANNULA SYSTEM

The Clear Cannula System: Your Clear Choice

• Disposable cannula with both disposable and reusable obturator available

• Available in both 90 mm and 110 mm; the 110-mm length offers access to the deeper hip joint while maintaining visibility

• Combine with DePuy Synthes Mitek Sports Medicine FMS DUO+ Fluid Management System for optimal performance

Triple-Seal Dam

• Provides fluid retention with minimal leakage—key in arthroscopy

• Allows easy passage of suture and instruments

• The first step in fluid management in your arthroscopic hip procedures


HIP PROCEDURE SYSTEM

The DePuy Synthes Mitek Sports Medicine Hip Procedure System is an extensive offering of precision instruments that have been designed for hip arthroscopy. This wide range of tools puts the appropriate solutions in your hands every step of the way—with hip-joint access and tissue and suture management solutions—and much more. The Hip Procedure System brings you optimal ergonomics and tip designs along with:

• 190-mm working length

• Curves of varying angles: up, right, and left to reach the hard-to-access areas in the hip

• Tools for the standard procedure as well as unexpected moments

The Hip Procedure System is delivered in its own tray, designed in partnership with OR personnel to ensure optimized procedural flow. The tray also provides for a convenient central location for additional instruments.

• 5.5 and 6.0 Hip Slotted Cannula

• Hip Suture Manipulator

• Hip Biter Straight and 15º Up

• Hip Grasper 20º Right, 20º Left, and Straight

• 4.0, 4.5, 5.0, 5.5, and 6.0 Hip Cannulated SwitchStick

• Handle, Hip SwitchStick

• Hip Suture Passer, Straight and 15º Up

• Hip CordCutter

• Hip Knot Manipulator

• Hip Curette, 20º

• Hip TissLib Blade, 20º Down

• Hip Probe, 90º

5.5 and 6.0 Hip Slotted Cannula


THE VAPR VUE SYSTEM WITH COOLPULSE TECHNOLOGY

The VAPR VUE System with COOLPULSE Technology is the next-generation radiofrequency system that provides clear and sustained visibility, enhanced procedural efficiency, and exceptional flexibility.Proprietary COOLPULSE Technology provides quicker tissue ablation while generating equal or less heat.*

Features and Benefits

• Unique power pulses enable faster and more rapid ablation while generating equal or less heat

• Targeted ablation minimizes risk of accidental damage to healthy tissue

• Easy and quick adjustment of ablation and coagulation settings over a wide power range to optimize probe performance based on anatomical considerations

*As compared to ARTHROCARE® SUPER TURBOVAC® during in vitro testing2


FMS DUO+ FLUID MANAGEMENT SYSTEM

The FMS DUO+ System lets you focus on your patient and the procedure—not on operating the pump. Complications from extravasation in hip arthroscopy are well documented.6,7 With FMS DUO+ System, you’re in control when conditions change, allowing you to adjust pressure or flow at a moment’s notice with a clear field of vision.• Enables optimal visibility by managing both inflow and outflow, and

delivering smooth, continuous flow

• Controls pressure and flow to address extravasation concerns in hip arthroscopy

• Simplifies setup and minimizes prep time for greater operating-room efficiency

Features and Benefits

• Controls pressure and flow independently for extravasation prevention

• Red pedal—pressure control to bleeding

• Blue pedal—flow control to clear debris without increasing pressure

• Enhances operating room efficiencies by helping to shorten procedure times, decrease patient traction time, and lower costs


HIP IN A BOX

The Hip in a Box training model is an advanced training tool designedto provide tactile feedback and allow surgeons to practice:

• Portal placement

• Joint access

• Labral repair

Training components

The Hip in a Box training model consists of a base, a replaceable hip joint, and a replacement skin (either transparent or opaque) that fits over the joint.

Benefits

• Replicates patient set up, allowing for hip joint distraction and femur rotation

• The radio-opaque design allows for use with a C-arm

• The clear skin aids in viewing the trajectory into the joint

• Hip in a Box is an ideal demonstration tool for educating residents, fellows, as well as patients

over the joint.


ORDERING INFORMATION

Hip Access

Product Code Product Name Quantity Unit260003 Hip Blade Curved 1 Each260010 Hip Blade Straight 1 Each260012 Hip Access Kit No Blade 1 Box Hip Needle 16G x 6” Hip Needle 16G x 7” 2 Guidewires 0.49 x 17.5” Surgical Marker Surgical Ruler Syringe 30 mL260009 Hip Access Kit Curved Blade 1 Box260011 Hip Access Kit Straight Blade 1 Box

GRYPHON Family213042 GRYPHON Hip Guide, Sawtooth 1 Each213044 GRYPHON Hip Guide, Fishmouth 1 Each210812 GRYPHON T BR Anchor w/ORTHOCORD 1 Each210811 GRYPHON T BR DS Anchor w/ORTHOCORD 1 Each210814 GRYPHON P BR Anchor w/ORTHOCORD 1 Each210813 GRYPHON P BR DS Anchor w/ORTHOCORD 1 Each210031 GRYPHON PEEK Anchor w/ORTHOCORD 1 Each210030 GRYPHON PEEK DS Anchor w/ORTHOCORD 1 Each211038 GRYPHON Obturator 1 Box211036 GRYPHON Drill Bit 1 Box211035 GRYPHON Tap 1 Box211041 GRYPHON Blunt Obturator 1 Box

Cannulas214110 Threaded 5.5 x 90 mm 5 Box214122 Threaded 8.5 x 90 mm 5 Box214112 Partially Threaded 7 x 110 mm 5 Box214109 5.5 x 90 mm Reusable Obturator 1 Each214121 8.5 x 90 mm Reusable Obturator 1 Each214111 7 x 110 mm Reusable Obturator 1 Each

Hip Procedure System214155 Hip Procedure System and Instruments 1 Set214135 5.5 Hip-Slotted Cannula 1 Each214136 6.0 Hip-Slotted Cannula 1 Each214139 Hip Biter—Straight 1 Each214137 Hip Biter—15 Up 1 Each214144 Hip Grasper—20 Right 1 Each214143 Hip Grasper—20 Left 1 Each

214147 Hip Grasper—Straight 1 Each214013 Hip Suture Passer—Straight 1 Each214009 Hip Suture Passer—Up 1 Each214146 Hip Suture Manipulator 1 Each214138 Hip CordCutter 1 Each214145 Hip Knot Manipulator 1 Each214142 Hip Curette 20 1 Each214148 Hip TissLib Blade—20 down 1 Each214131 Hip Probe 90 1 Each214134 4.0 Hip Cannulated SwitchStick 1 Each

Hip Procedure System (cont.)214132 5.5 Hip Cannulated SwitchStick 1 Each214133 6.0 Hip Cannulated SwitchStick 1 Each214154 4.5 Hip Cannulated SwitchStick 1 Each214153 5.0 Hip Cannulated SwitchStick 1 Each214151 Handle, Hip SwitchStick 1 Each

Sterilization Tray215503 Hip Procedure System 1 Set215509 Hip Sterilization Case 1 Each215510 Lid, Hip Sterilization Case 1 Each215507 Hip Entry and Tissue Removal Tray 1 Each215504 Hip Slotted Cannula Tray 1 Each215505 Hip Tissue and Suture Management Tray 1 Each215508 Hip Labral Repair Tray 1 Each215506 Hip Entry Tray Pin Mat Accessory 1 Each

VAPR® System228146 COOLPULSE® 90 Electrode 1 Each228147 COOLPULSE 90 (with hand controls) Electrode 1 Each227204 Premiere 90 1 Each225370 S90 1 Each228370 S90 (with hand controls) 1 Each227504 Premiere 50 1 Each228504 Premiere 50 (with hand controls) 1 Each227355 S50 1 Each 225021 VAPR System 3 1 Each225024 VAPR VUE System Generator 1 Each227214 VAPR VUE System Wireless Footswitch 1 Each225023 VAPR System Wired Footswitch 1 Each225005 VAPR System Power Cord 1 Each

FMS284580 FMS DUO+ System 1 Each284172 FMS DUO+ 2-Way Foot Pedal-Board 1 Each284590 FMS SOLO® Irrigation Pump 1 Each284171 FMS SOLO 1-Way Foot Pedal-Board 1 Each284504 InFlow Tubing FMS DUO+/FMS SOLO System 24 Pak284610 Outflow Tubing without One-Way Valve 24 Pak284649 Outflow Tubing with One-Way Valve (Reusable Setup) 24 Pak281103 Intermediary Tubing without One-Way Valve 24 Pak281142 Intermediary Tubing with One-Way Valve (Reusable Setup) 24 Pak

Hip in a Box Training Model*240100 HIAB Model (1 clear skin + 1 joint) 1 Each240101 HIAB Clear Skin Replacement 1 Each240102 HIAB Opaque Skin Replacement 1 Each240103 HIAB Joint Replacement 1 Each

*This is a training model. This is not for human use.

References

1. U.S. Market for Orthopedic Soft Tissue Repair and Sports Medicine. iData Research Inc. 2011.

2. Oslan A, Martini N, Barry D, Tissington B. Comparative study of in vitro ablation rate and temperature increases for arthroscopic radiofrequency probes. Mitek Sports Medicine, Inc. white paper. 2010.

3. Weidner J, Büchler L, Beck M. Hip capsule dimensions in patients with femoroacetabular impingement: a pilot study. Clin Orthop Relat Res. 2012;470(12):3306-3312.

4. Grant Bethany, Bhattacharyya SK, Ginggen LF, Mafilios MS, Busconi BD. Biomechanical evaluation of high performance blades used in hip arthroscopy. 2013. Clinical Orthopaedic Society Annual Meeting 2013, Buffalo NY.

5. Data obtained from implantation studies in rats. Data on file. Mitek Sports Medicine.

6. Verma M, Sekiya JK. Intrathoracic fluid extravasation after hip arthroscopy. Arthroscopy. 2010;26(9 Suppl):S90-94.

7. Sampson TG. Complications of hip arthroscopy. Clin Sports Med. 2001;20(4):831-835.

8. Ilahi OA, Younas SA, Ho DM, Noble PC. Security of knots tied with ethibond, fiberwire, ORTHOCORD Suture, or ultrabraid. Am J Sports Med. 2008;36(12):2407-2414.

9. Suchenski M, McCarthy MB, Chowaniec D, Hansen D, et al. Material properties and composition of soft tissue fixation. Arthroscopy. 2010;26(6):821-831.

10. Barber FA, Dockery WD, Hrnack SA. Long-term degradation of a poly-lactide co-glycolide/ß-tricalcium phosphate biocomposite interference screw. Arthroscopy. 2011;27(5):637-643.

11. Barber FA, Hurley JA. Clinical Update: imagining and in vivo absorption of ß-TCP/PLGA interference screws used in ACL reconstruction. Mitek Sports Medicine, Inc. white paper. 2009.

CA#12885B Issued: 03/14

©DePuy Synthes Mitek Sports Medicine, a division of DOI 2014. All rights reserved.

Limited Warranty and Disclaimer: DePuy Mitek, Inc. products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

Not all products are currently available in all markets.

Third party trademarks used herein are trademarks of their respective owners.

This publication is not intended for distribution in USA.

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DePuy Mitek, Inc.325 Paramount Dr. Raynham, MA 02767USATel: +1 (800) 382-4682

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DePuy International Ltd. St. Anthony’s RoadBeestonLeedsWest YorkshireLS11 8DTUnited KingdomTel: +44 (0)113 387 7800Fax: +44 (0) 113 387 7890

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