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Products and Services Catalogue Solid and Flexible Bio-Processed Allograft Implants

Advancing Tissue Innovations Since 1972

Updated June 2011


A History of Providing Highest Quality and Innovation Mount 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 Techniques To 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

Products and Services Catalogue

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Product Excellence Overview Governance & Standards

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

Quality Systems

DD FDA — Good Manufacturing Practices DD FDA — Good Tissue Practices DD ISO 9002 Adopted Practices

Donor Testing

Nucleic Acid Tests DD West Nile virus Nucleic Acid Test (WNV RNA) DD Hepatitis B Nucleic Acid Test (HBV DNA) DD Hepatitis C Nucleic Acid Test (HCV RNA) DD HIV Nucleic Acid Test (HIV RNA) Serology Tests DD Hepatitis B surface antigen (HBsAg) DD Hepatitis B core Antibody (HBcAb) DD Hepatitis C Antibody (HCV Ab) DD HTLV 1&2 Ab (HTLV Ab) DD HIV 1& 2 Ab (HIV Ab) DD Syphilis (RPR) DD CMV IgG Ab

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

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Sterilization Techniques

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

Packaging Materials

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

Lyophilized Tissues

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

Distribution

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

Customer Service

DD 24/7/365 Ordering and Inquiries DD Emergency Requests & Delivery DD Product returns accepted

Products and Services Catalogue


Product Type Overview Types

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

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

Packaging Mount 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.

Standard packaging.

Box containing bone and tissue.

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Ordering Allograft Implants and Services Healthcare 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 Policy We 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

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Products and Services Catalogue


Allograft Implants for Orthopaedic Applications Products Centre Large Traditional (LT) Grafts Items

Canal Diameter

Length (Min.)

Femur Whole

Catalogue Number (Frozen) 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.)

Fibula/Ulna/Radius Shaft

Length (Min.)

Catalogue Number (Frozen)

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

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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

SGF4

SGL4

SGF5

SGL5

SGF6

SGL6

Large 15-25x10x25-30mm Fibula/Radius/Ulna Cortical Segment

Small 40-65mm

Femoral Ring

5-25mm Height

Large 66-99mm

CANCELLOUS BONE (CB) GRAFTS

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Items

Volume

Catalogue Number (Frozen)

Catalogue Number (Lyophilized)

Cancellous Ground Bone

5cc

CBF1

CBL1

1-4mm

15cc

CBF2

CBL2

20cc

CBF3

CBL3

30cc

CBF4

CBL4

40cc

CBF5

CBL5

60cc

CBF6

CBL6

90cc

CBF7

CBL7

Cancellous Ground Bone

15cc

CBF8

CBL8

4-10mm

20cc

CBF9

CBL9

30cc

CBF10

CBL10

40cc

CBF11

CBL11

60cc

CBF12

CBL12

90cc

CBF13

CBL13

Products and Services Catalogue


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

15cc

CCF7

CCL7

20cc

CCF8

CCL8

30cc

CCF9

CCL9

40cc

CCF10

CCL10

60cc

CCF11

CCL11

90cc

CCF12

CCL12

Cortico-Cancellous Ground Bone 4-10mm

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

15mm (Width)X25mm(Length)

FG4

With Bone Block

& 100mm (Quad. Length)

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

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Notes

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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


Mount Sinai Allograft Technologies Products and Services Catalogue