advanced wedge technology - emedia - · pdf fileium wedges provide foot and ankle surgeons...

Advanced Wedge Technology Unique Options for Foot & Ankle Surgeons

Designed by Foot & Ankle Surgeons for Foot & Ankle Surgeons

• Confidence • Consistency • Convenience

Wedge Technologyfor Foot & Ankle ApplicationsWright’s “Focused Excellence” in foot and ankle surgery continues to develop cutting edge technologies which help simplify complex surgeries with a goal to improve outcomes. ALLOPURE® Allograft Bone Wedges and BIOFOAM® Cancellous Titanium Wedges provide foot and ankle surgeons

unique options and the simplicity of pulling size specific, allograft or metal wedges off the shelf for Evans and Cotton osteotomies and other grafting needs. Assessment of the osteotomy is simple and choosing the graft size quick, allowing appropriate correction to be achieved.

IMPROVINGResults

BIOFOAM® Wedge System

ALLOPURE®

Bicortical Wedge

ALLOPURE®

Tricortical WedgeTricortical Wedge

®

us ns

choosing the graft size quick, allowing apprcorrection to be achieved.ium Wedges provide foot and ankle surgeons

ALLOPURE®

Cancellous Wedge

Advanced Wedge Technology

ALLOPURE® Bicortical Wedge

• CellRight human bone pre-processed with BioRinse™ cleaning process and terminally sterilized with gamma irradiation.

• Tricortical bone grafts can be used in a variety of orthopedic applications such as: Lapidus, Cotton, Evans, & other procedures requiring superior strength.

• 3 Cortical sides provide structure, strength, and stability.

• The rough cortical sides resists migration while the porous scaffold provides optimal surface area for osteoconduction.

ALLOPURE® Cancellous Wedge

• AlloSource® human bone pre-processed with AlloTrue® cleaning process and terminally sterilized with gamma irradiation.

• LifeLink® human bone pre-processed with Allowash® cleaning process and terminally sterilized with gamma irradiation.

• Pre-sized and designed for Evans and Cotton osteotomies.

• Two-sided cortical rim provides natural strength.

ALLOPURE® Tricortical Block

BIOFOAM® Wedge System*

ORDERING INFORMATION

• Maintain strength – BIOFOAM® Cancellous Titanium™ matrix maintains its compressive strength throughout the remodeling process.

• Designed for precise and reliable correction – Wedges available in two orientations and 15 sizes.

• Extensive bone Ingrowth – Porosity of the osteoconductive matrix allows for rapid integration of bone.

• RTI Human bone is pre-processed with the BioCleanse® cleaning process and terminally sterilized with either gamma irradiation or gas plasma.

• Ready-to-Use Cotton and Evans osteotomy configurations with minimal sizing required.

• Use with the Evans Instrument kit to achieve an 8mm, 10mm, or 12mm wedge.



* Ancillary Fixation Required


Part # Description

OP101020 Small Tricortical Block

OP101022 Medium Tricortical Block

OP101024 Large Tricortical Block

Part # Description Depth x Width x Thickness (mm)

46S51808 BIOFOAM® Evans Wedge 18 x 18 x 846S51810 BIOFOAM® Evans Wedge 18 x 18 x 1046S51812 BIOFOAM® Evans Wedge 18 x 18 x 1246S52008 BIOFOAM® Evans Wedge 20 x 20 x 846S52010 BIOFOAM® Evans Wedge 20 x 20 x 1046S52012 BIOFOAM® Evans Wedge 20 x 20 x 1246S52208 BIOFOAM® Evans Wedge 22 x 22 x 846S52210 BIOFOAM® Evans Wedge 22 x 22 x 1046S52212 BIOFOAM® Evans Wedge 22 x 22 x 12

Part # Description Depth x Dorsal Width x Plantar Width x Thickness (mm)

46S01645 BIOFOAM® Cotton Wedge 16 x 14 x 10 x 4.546S01655 BIOFOAM® Cotton Wedge 16 x 14 x 10 x 5.546S01665 BIOFOAM® Cotton Wedge 16 x 14 x 10 x 6.546S02045 BIOFOAM® Cotton Wedge 20 x 14 x 10 x 4.546S02055 BIOFOAM® Cotton Wedge 20 x 14 x 10 x 5.546S02065 BIOFOAM® Cotton Wedge 20 x 14 x 10 x 6.5

Part # Description

86620006 6mm ALLOPURE® Cancellous Cotton Wedge

86660012 8, 10, or 12mm ALLOPURE® Cancellous Wedge

4666KIT1 Evans Instrument Kit

Part # Description

86660006 6mm ALLOPURE® Cotton Wedge (AlloSource®)

86660800 8mm ALLOPURE® Evans Wedge (AlloSource®)



86LL0006 6mm ALLOPURE® Cotton Wedge (LifeLink®)

86LL0800 8mm ALLOPURE® Evans Wedge (LifeLink®)



Product Supplier Size (mm) Shape(s)Rehydration

Time (per IFU)

Room/Ambient Temp Definition

In-process Cleaning Method

Sterilization Method

Final Product Configuration

Shelf-life Tissue Bank Certificates

Supplier AATB

Accredited

ALLOPURE® Cancellous

WedgesRTI

P/N T1 T2 L W

Minimum of

30 seconds1-37˚C BioCleanse®

Gamma Irradiation (low

dose, low temp), or Gas Plasma [SAL reduction

10-6]

Freeze-dried; in Tyvek, and foil/polymer pouches;

carton with window

3 years

http://www.rtix.com/about/

accreditation-certification/

Yes

86620006(Cotton Wedge) 6 2.5 24 14

86660012(Full Evans Wedge) 12 3.5 38 22

Cut Evans Wedge* 8 3.5 20 22



ALLOPURE® Bicortical Wedges

AlloSource®

P/N T1 T2 L W

Approx. 10 minutes

1-37˚C AlloTrue®


dose, low temp), [SAL reduction

10-6]

Freeze-dried; in Tyvek, and

polymer pouches; carton with

window

5 years

http://www.allosource.org/

about-allo-source/

regulator- resource- center/

certificates-and-licenses/

Yes

86660006 2.5 6 24 14

86660800 3.5 8 20 22

86661000 5.5 10 20 22

86661200 7.5 12 20 22

ALLOPURE® Bicortical Wedges

LifeLink®

P/N H1 H2 L W

Until thoroughly

hydrated11-38˚C AlloWash®

Gamma Irradiation

[SAL reduction

10-6]

Freeze-dried; in 3 Tyvek pouches;

carton with window

5 years

http://www.lifelinktb.org/

Phys_Hosp/ Certification_

Details

Yes

86LL0006 2.5 6 24 14

86LL0800 3.5 8 20 22

86LL1000 5.5 10 20 22

86LL1200 7.5 12 20 22

ALLOPURE® Tricortical

BlocksCellRight

P/N T1 T2 L W

Minimum of

30 -60 minutes

15-30˚C BioRinse™

Gamma Irradiation

[SAL reduction

10-6]

Freeze-dried; in Tyvek,

and polymerpouches; carton

with window

5 years

Contact Wright Customer Service at customerservice@

wmt.com

Yes

OP101020 (SMALL) 8-12 6-12 >20 18-25

OP101022 (MEDIUM) 13-19 8-19 >20 >18

OP101024 (LARGE) >19 >16 >20 >18

ALLOPURE® Allograft Wedges

Full Evans Wedge

Cut Evans Wedge

Cotton Wedge

*NOTE: 86660012 is actually 3 parts in one. An 8, 10, or 12mm wedge may be cut from this one wedge size.

Room/Ambient Temp Definition

In-process Cleaning Method

Sterilization Method

Final Product Configuration

Shelf-life Tissue Bank Certificates

Supplier AATB

Accredited

1-37˚C BioCleanse®


dose, low temp), or Gas Plasma [SAL reduction

10-6]

Freeze-dried; in Tyvek, and foil/polymer pouches;

carton with window

3 years

http://www.rtix.com/about/

accreditation-certification/

Yes

1-37˚C AlloTrue®


dose, low temp), [SAL reduction

10-6]

Freeze-dried; in Tyvek, and

polymer pouches; carton with

window

5 years

http://www.allosource.org/

about-allo-source/

regulator- resource- center/

certificates-and-licenses/

Yes

11-38˚C AlloWash®

Gamma Irradiation

[SAL reduction

10-6]

Freeze-dried; in 3 Tyvek pouches;

carton with window

5 years

http://www.lifelinktb.org/

Phys_Hosp/ Certification_

Details

Yes

15-30˚C BioRinse™

Gamma Irradiation

[SAL reduction

10-6]

Freeze-dried; in Tyvek,

and polymerpouches; carton

with window

5 years

Contact Wright Customer Service at customerservice@

wmt.com

Yes

http://www.rtix.com/about/accreditationcertification/

http://www.allosource.org/about-allosource/regulator-resource-center/certificates-and-licenses/

http://www.lifelinktb.org/Phys_Hosp/Certification_Details

®

Tissue Bank

™Trademarks and ®Registered marks of Wright Medical Technology, Inc. ©2014 Wright Medical Technology, Inc.All Rights Reserved.

011320A 14-Nov-2014

Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117800 238 7117901 867 9971www.wmt.com

Wright Medical EMEAAtlas Arena, Australia BuildingHoogoorddreef 71101 BA Amsterdamthe Netherlands011 31 20 565 9060

Wright Medical UK Ltd.Unit 1, Campus FiveLetchworth Garden CityHertfordshire SG6 2JF United Kingdom011 44 (0)845 833 4435

advanced wedge technology - emedia - · pdf fileium wedges provide foot and ankle surgeons...

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