mount sinai allograft technologies products and services catalogue

10
Advancing Tissue Innovations Since 1972 Updated June 2011 Products and Services Catalogue Solid and Flexible Bio-Processed Allograft Implants

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Solid and Flexible Bio-Processed Allograft Implants

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Page 1: Mount Sinai Allograft Technologies Products and Services Catalogue

Advancing Tissue Innovations Since 1972

Updated June 2011

Products and Services CatalogueSolid and Flexible Bio-Processed Allograft Implants

Page 2: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue 1

A History of Providing Highest Quality and InnovationMount Sinai Allograft Technologies, a department of Mount Sinai Hospital formerly known as the The Rubinoff Bone Bank, has been a leader in advanced tissue innovations since 1972.

We are committed to providing the highest quality of bone and tissue allograft products – as well as continued innovation in the development of allograft implants for transplantation. We are dedicated to meeting all surgical needs and to exceed all client expectations.

We work closely with the Trillium Gift of Life Network to promote their mission of increasing donor awareness and to ensure that the wishes of Ontario donor families’ are carried out with the utmost care and respect.

Our allograft implants are 100% Ontario produced, human allograft tissues.

Industry Leading Processing TechniquesTo produce the safest and highest quality Canadian produced allograft implants, Mount Sinai Allograft Technologies leverages the expertise of a variety of medical experts, state-of-the art laboratory testing, proven bio-processing techniques, tested irradiation methods and preferred packaging systems.

Our dedicated, highly experienced and trained staff are always ready to support your needs.

Large tissue sample of clean bone Ground bone sample

Page 3: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue2

Product Excellence Overview

Governance & Standards

D Heath Canada Registered D Canadian Standards Association D American Association of Tissue Banks Accredited D Ontario Laboratory Accredited D College of American Pathologist Accredited D Clinical Laboratory Improvement Amendments Accredited

Quality Systems D FDA — Good Manufacturing Practices D FDA — Good Tissue Practices D ISO 9002 Adopted Practices

Donor Testing Nucleic Acid Tests

D West Nile virus Nucleic Acid Test (WNV RNA) D Hepatitis B Nucleic Acid Test (HBV DNA) D Hepatitis C Nucleic Acid Test (HCV RNA) D HIV Nucleic Acid Test (HIV RNA)

Serology Tests

D Hepatitis B surface antigen (HBsAg) D Hepatitis B core Antibody (HBcAb) D Hepatitis C Antibody (HCV Ab) D HTLV 1&2 Ab (HTLV Ab) D HIV 1& 2 Ab (HIV Ab) D Syphilis (RPR) D CMV IgG Ab

Donor Recovery & Processing

D Aseptic Zone & Sequential Recovery Techniques D Aseptic Processing Techniques D Class B, C Processing Environment D Validated Methods to Eliminate Cross-contamination

Sterilization Techniques

D Gamma-Irradiation D Certified 25kGy Dose to Effectively Eliminate Bacteria

Packaging Materials

D Moisture Barrier D Product Visibility D Medical Device Approved to Prevent Cytotoxicity

Lyophilized Tissues

D Freeze-dried to a Moisture Level of Less Than 6% D Room Temperature Storage

Distribution D Product Specification and Measurements D Recipient Tracking Fax-back Form D Secure and On-time Delivery D Consignment inventory available

Customer Service D 24/7/365 Ordering and Inquiries D Emergency Requests & Delivery D Product returns accepted

Page 4: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue 3

Product Type OverviewTypes sTorage

Large Traditional Implants Frozen

Cortical Strut Impants Frozen

Fresh Osteochondral Implants Refrigerated

Cancellous Ground Bone Frozen and Freeze-dried

Cortico-Cancellous Ground Bone Frozen and Freeze-dried

Tendons and Soft Tissues Frozen

Spinal Implants Frozen and Freeze-dried

D Freeze-dried tissue may be stored at ambient (room) temperature for up to five (5) years.

D Frozen musculoskeletal tissue may be stored at -40 degrees C or colder for five (5) years or -20 degrees C for temporary storage of up to six months.

PackagingMount Sinai Allograft Technologies supplies the best quality in packaging systems to surgeons and operating room staff. Our pursuit of first-class quality ensures that each tissue packaged maintains integrity and sterility. Our packaging is completed and heat sealed in a class-C or better clean room environment. The materials we use are proven to be non-toxic and made up of pure High Density Polyethylene polymer which is one of the more biocompatible and hypoallergenic materials available. In addition, each package is easy to open using a flexible peel-back closure.

Box containing bone and tissue.

Standard packaging.

Page 5: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue4

Ordering Allograft Implants and ServicesHealthcare facilities and surgeons are approved to order allograft tissues from Mount Sinai Allograft Technologies. Only licensed surgeons and clinical professionals are permitted to transplant allograft implants.

Phone Orders: 416-586-8870

Fax Orders: 416-586-4458

On-line orders: www.allografttechnologies.com

Special Orders

Allograft tissues can be ordered 24 hours a day, 7 days a week and 365 days a year. Emergency orders can be fulfilled on short notice. In many cases, orders can be shipped for same day or next day delivery. Please call us for more information on rush orders.

Consignment Services

We are pleased to offer a bulk supply of allograft products on a consignment services basis to our higher volume, pre-approved users.

This unique service will permit users to always have an adequate supply of high quality tissues on hand, preventing stock-outs, and allow ordering of customized grafts.

Additional benefits of our Consignment Services include more effective surgery scheduling and operating room efficiency gains. Please contact us for additional details regarding consignments services.

Return PolicyWe are pleased to accept returns of unused items subject to our return policy. Please see our return policy for more details on the last page of this catalogue.

Payment

Account statements are sent on a monthly basis and are due within 30 days from the issue date, unless stated otherwise. Payments can be made via corporate cheque.

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex 539-600 University Avenue Toronto, Ontario, Canada M5G 1X5

General Inquiries t 416-586-8870 f 416-586-4458

Visit us at www.allografttechnologies.com

Page 6: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue 5

Allograft Implants for Orthopaedic Applications Products Centre

Large TradiTionaL (LT) grafTs

Items Canal Diameter Length (Min.) Catalogue Number (Frozen)

Femur Whole LT1

Femur Half Proximal With Head Varies 200mm LT2

Femur Half Proximal Minus Head Varies 200mm LT3

Femur Half Distal With Head Varies 200mm LT4

Tibia Whole LT5

Tibia Half Proximal 200mm LT6

Tibia Half Distal 200mm LT7

Humerus Whole LT8

Humerus Half Proximal With Head 150mm LT9

Fibula Whole LT10

Radius Whole LT11

Ulna Whole LT12

Acetabulum Full LT13

Iliac Crest Full LT14

Hemi-Pelvis LT15

CorTiCaL sTruT (Cs) grafTs

Items Diameter (Min) Width (Min.) Length (Min.) Catalogue Number (Frozen)

Fibula/Ulna/Radius Shaft 100-150mm CS1

Femur Shaft 25mm 150mm CS2

Femur Plate 20mm 150mm CS3

Femur Head 40mm CS4

Tibia Shaft 150mm CS5

Tibia Plate 20mm 150mm CS6

Humeral Shaft 15mm 100mm CS7

Humeral Head 40mm CS8

Page 7: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue6

fresh osTeoChondraL (fo) grafTs

Items Canal Diameter Catalogue Number (Refrigerated)

Femur Medial Condyle Varies FO1

Femur Lateral Condyle Varies FO2

Tibia Medial Plateu Varies FO3

Tbia Lateral Plateu Varies FO4

Knee Whole Varies FO5

Talus Varies FO6

Os Calcaneous Varies FO7

Ankle Whole Varies FO8

Shoulder Whole Varies FO9

Elbow Whole Varies FO10

grafTs for spinaL (sg) appLiCaTions

Items Height X Width X Length Catalogue Number (Frozen)

Catalogue Number (Lyophilized)

Patella Wedge 15x13x33mm SGF1 SGL1

Ilium Strip Tri-Cortical 15-25x10x65mm SGF2 SGL2

Ilium Block Tri-Cortical 15-25x20x65mm SGF3 SGL3

Iliac Crest Wedge Small 9-14x9x18-25mm

Large 15-25x10x25-30mm

SGF4 SGL4

Fibula/Radius/Ulna Cortical Segment

Small 40-65mm

Large 66-99mm

SGF5 SGL5

Femoral Ring 5-25mm Height SGF6 SGL6

CanCeLLous Bone (CB) grafTs

Items Volume Catalogue Number (Frozen)

Catalogue Number (Lyophilized)

Cancellous Ground Bone

1-4mm

5cc CBF1 CBL1

15cc CBF2 CBL2

20cc CBF3 CBL3

30cc CBF4 CBL4

40cc CBF5 CBL5

60cc CBF6 CBL6

90cc CBF7 CBL7

Cancellous Ground Bone

4-10mm

15cc CBF8 CBL8

20cc CBF9 CBL9

30cc CBF10 CBL10

40cc CBF11 CBL11

60cc CBF12 CBL12

90cc CBF13 CBL13

Page 8: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue 7

CorTiCo-CanCeLLous (CC) Bone grafTs

Items Volume Catalogue Number (Frozen)

Catalogue Number (Lyophilized)

Cortico-Cancellous Ground Bone 1-4mm

15cc CCF1 CCL1

20cc CCF2 CCL2

30cc CCF3 CCL3

40cc CCF4 CCL4

60cc CCF5 CCL5

90cc CCF6 CCL6

Cortico-Cancellous Ground Bone 4-10mm

15cc CCF7 CCL7

20cc CCF8 CCL8

30cc CCF9 CCL9

40cc CCF10 CCL10

60cc CCF11 CCL11

90cc CCF12 CCL12

fLexiBLe grafTs (fg) for sporTs MediCine appLiCaTions

Items Minimum Length Of Tendon Catalogue Number (Frozen)

Achillies Tendon With Bone Block 160mm FG1

Patellar Tendon Whole With Bone Block 30mm (Width)X25mm(Length) FG2

Patellar Tendon Preshaped With Bone Block 15mm (Width)X25mm(Length) FG3

Patellar Tendon W/Quad. Tendon

With Bone Block

15mm (Width)X25mm(Length)

& 100mm (Quad. Length)

FG4

Anterior Tibialis Tendon With Bone Block 230mm FG5

Posterior Tibialis Tendon With Bone Block 230mm FG6

Gracilis Tendon 230mM FG7

Semi-Tendenous 230mm FG8

Peroneus Longus Tendon 230mm FG9

Bundled Tendons (Gracilis & Semi-T.) 230mm Each FG10

Meniscus Whole With Bone Block Varies FG11

Meniscus Medial With Bone Block Varies FG12

Meniscus Lateral With Bone Block Varies FG13

Fascia Lata 60mmx140mm FG14

Page 9: Mount Sinai Allograft Technologies Products and Services Catalogue

Products and Services Catalogue8

Notes

Page 10: Mount Sinai Allograft Technologies Products and Services Catalogue

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex 539-600 University Avenue Toronto, Ontario, Canada M5G 1X5 t 416-586-8870 201104586