Allograft Products and Services Catalogue - Mount Sinai Hospital
Allograft Products and Services Catalogue - Mount Sinai Hospital
Allograft Products and Services Catalogue - Mount Sinai Hospital
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<strong>Products</strong> <strong>and</strong><br />
<strong>Services</strong> <strong>Catalogue</strong><br />
Solid <strong>and</strong> Flexible Bio-Processed <strong>Allograft</strong> Implants<br />
Advancing Tissue Innovations Since 1972<br />
Updated June 2011
A History of Providing Highest Quality <strong>and</strong> Innovation<br />
<strong>Mount</strong> <strong>Sinai</strong> <strong>Allograft</strong> Technologies, a department of <strong>Mount</strong> <strong>Sinai</strong> <strong>Hospital</strong> formerly known as the The Rubinoff<br />
Bone Bank, has been a leader in advanced tissue innovations since 1972.<br />
We are committed to providing the highest quality of bone <strong>and</strong> tissue allograft products – as well as continued<br />
innovation in the development of allograft implants for transplantation. We are dedicated to meeting all<br />
surgical needs <strong>and</strong> to exceed all client expectations.<br />
We work closely with the Trillium Gift of Life Network to promote their mission of increasing donor awareness<br />
<strong>and</strong> to ensure that the wishes of Ontario donor families’ are carried out with the utmost care <strong>and</strong> respect.<br />
Our allograft implants are 100% Ontario produced, human allograft tissues.<br />
Industry Leading Processing Techniques<br />
To produce the safest <strong>and</strong> highest quality Canadian produced allograft implants, <strong>Mount</strong> <strong>Sinai</strong> <strong>Allograft</strong><br />
Technologies leverages the expertise of a variety of medical experts, state-of-the art laboratory testing,<br />
proven bio-processing techniques, tested irradiation methods <strong>and</strong> preferred packaging systems.<br />
Our dedicated, highly experienced <strong>and</strong> trained staff are always ready to support your needs.<br />
Large tissue sample of clean bone<br />
Ground bone sample<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong> 1
Product Excellence Overview<br />
Governance &<br />
St<strong>and</strong>ards<br />
Quality Systems<br />
Donor Testing<br />
Donor Recovery &<br />
Processing<br />
Sterilization<br />
Techniques<br />
Packaging<br />
Materials<br />
Lyophilized<br />
Tissues<br />
Distribution<br />
Customer Service<br />
DDHeath Canada Registered<br />
DDCanadian St<strong>and</strong>ards Association<br />
DDAmerican Association of Tissue Banks Accredited<br />
DDOntario Laboratory Accredited<br />
DDCollege of American Pathologist Accredited<br />
DDClinical Laboratory Improvement Amendments Accredited<br />
DDFDA — Good Manufacturing Practices<br />
DDFDA — Good Tissue Practices<br />
DDISO 9002 Adopted Practices<br />
Nucleic Acid Tests<br />
DDWest Nile virus Nucleic Acid Test (WNV RNA)<br />
DDHepatitis B Nucleic Acid Test (HBV DNA)<br />
DDHepatitis C Nucleic Acid Test (HCV RNA)<br />
DDHIV Nucleic Acid Test (HIV RNA)<br />
Serology Tests<br />
DDHepatitis B surface antigen (HBsAg)<br />
DDHepatitis B core Antibody (HBcAb)<br />
DDHepatitis C Antibody (HCV Ab)<br />
DDHTLV 1&2 Ab (HTLV Ab)<br />
DDHIV 1& 2 Ab (HIV Ab)<br />
DDSyphilis (RPR)<br />
DDCMV IgG Ab<br />
DDAseptic Zone & Sequential Recovery Techniques<br />
DDAseptic Processing Techniques<br />
DDClass B, C Processing Environment<br />
DDValidated Methods to Eliminate Cross-contamination<br />
DDGamma-Irradiation<br />
DDCertified 25kGy Dose to Effectively Eliminate Bacteria<br />
DDMoisture Barrier<br />
DDProduct Visibility<br />
DDMedical Device Approved to Prevent Cytotoxicity<br />
DDFreeze-dried to a Moisture Level of Less Than 6%<br />
DDRoom Temperature Storage<br />
DDProduct Specification <strong>and</strong> Measurements<br />
DDRecipient Tracking Fax-back Form<br />
DDSecure <strong>and</strong> On-time Delivery<br />
DDConsignment inventory available<br />
DD24/7/365 Ordering <strong>and</strong> Inquiries<br />
DDEmergency Requests & Delivery<br />
DDProduct returns accepted<br />
2<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong>
Product Type Overview<br />
Types<br />
Storage<br />
Large Traditional Implants Frozen<br />
Cortical Strut Impants Frozen<br />
Fresh Osteochondral Implants Refrigerated<br />
Cancellous Ground Bone Frozen <strong>and</strong> Freeze-dried<br />
Cortico-Cancellous Ground Bone Frozen <strong>and</strong> Freeze-dried<br />
Tendons <strong>and</strong> Soft Tissues Frozen<br />
Spinal Implants Frozen <strong>and</strong> Freeze-dried<br />
DDFreeze-dried tissue may be stored at ambient (room) temperature for up to five (5) years.<br />
DDFrozen musculoskeletal tissue may be stored at -40 degrees C or colder for five (5) years<br />
or -20 degrees C for temporary storage of up to six months.<br />
Packaging<br />
<strong>Mount</strong> <strong>Sinai</strong> <strong>Allograft</strong> Technologies supplies the best quality in packaging systems to surgeons <strong>and</strong> operating<br />
room staff. Our pursuit of first-class quality ensures that each tissue packaged maintains integrity <strong>and</strong> sterility.<br />
Our packaging is completed <strong>and</strong> heat sealed in a class-C or better clean room environment. The materials we<br />
use are proven to be non-toxic <strong>and</strong> made up of pure High Density Polyethylene polymer which is one of the<br />
more biocompatible <strong>and</strong> hypoallergenic materials available. In addition, each package is easy to open using a<br />
flexible peel-back closure.<br />
St<strong>and</strong>ard packaging.<br />
Box containing bone <strong>and</strong> tissue.<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong> 3
Ordering <strong>Allograft</strong> Implants <strong>and</strong> <strong>Services</strong><br />
Healthcare facilities <strong>and</strong> surgeons are approved to order allograft tissues from <strong>Mount</strong> <strong>Sinai</strong> <strong>Allograft</strong><br />
Technologies. Only licensed surgeons <strong>and</strong> clinical professionals are permitted to transplant allograft implants.<br />
Phone Orders: 416-586-8870<br />
Fax Orders: 416-586-4458<br />
On-line orders: www.allografttechnologies.com<br />
Special Orders<br />
<strong>Allograft</strong> tissues can be ordered 24 hours a day, 7 days a week <strong>and</strong> 365 days a year. Emergency orders can be<br />
fulfilled on short notice. In many cases, orders can be shipped for same day or next day delivery. Please call us<br />
for more information on rush orders.<br />
Consignment <strong>Services</strong><br />
We are pleased to offer a bulk supply of allograft products on a consignment services basis to our higher<br />
volume, pre-approved users.<br />
This unique service will permit users to always have an adequate supply of high quality tissues on h<strong>and</strong>,<br />
preventing stock-outs, <strong>and</strong> allow ordering of customized grafts.<br />
Additional benefits of our Consignment <strong>Services</strong> include more effective surgery scheduling <strong>and</strong> operating room<br />
efficiency gains. Please contact us for additional details regarding consignments services.<br />
Return Policy<br />
We are pleased to accept returns of unused items subject to our return policy. Please see our return policy<br />
for more details on the last page of this catalogue.<br />
Payment<br />
Account statements are sent on a monthly basis <strong>and</strong> are due within 30 days from the issue date, unless<br />
stated otherwise. Payments can be made via corporate cheque.<br />
<strong>Mount</strong> <strong>Sinai</strong> <strong>Hospital</strong><br />
Joseph <strong>and</strong> Wolf Lebovic Health Complex<br />
539-600 University Avenue<br />
Toronto, Ontario, Canada M5G 1X5<br />
General Inquiries<br />
t 416-586-8870<br />
f 416-586-4458<br />
Visit us at www.allografttechnologies.com<br />
4<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong>
<strong>Allograft</strong> Implants for Orthopaedic Applications <strong>Products</strong> Centre<br />
Large Traditional (LT) Grafts<br />
Items Canal Diameter Length (Min.) <strong>Catalogue</strong> Number<br />
(Frozen)<br />
Femur Whole<br />
LT1<br />
Femur Half Proximal With Head Varies 200mm LT2<br />
Femur Half Proximal Minus Head Varies 200mm LT3<br />
Femur Half Distal With Head Varies 200mm LT4<br />
Tibia Whole<br />
LT5<br />
Tibia Half Proximal 200mm LT6<br />
Tibia Half Distal 200mm LT7<br />
Humerus Whole<br />
LT8<br />
Humerus Half Proximal With Head 150mm LT9<br />
Fibula Whole LT10<br />
Radius Whole<br />
LT11<br />
Ulna Whole<br />
LT12<br />
Acetabulum Full<br />
LT13<br />
Iliac Crest Full<br />
LT14<br />
Hemi-Pelvis<br />
LT15<br />
Cortical Strut (CS) Grafts<br />
Items Diameter (Min) Width (Min.) Length (Min.) <strong>Catalogue</strong> Number<br />
(Frozen)<br />
Fibula/Ulna/Radius Shaft 100-150mm CS1<br />
Femur Shaft 25mm 150mm CS2<br />
Femur Plate 20mm 150mm CS3<br />
Femur Head 40mm CS4<br />
Tibia Shaft 150mm CS5<br />
Tibia Plate 20mm 150mm CS6<br />
Humeral Shaft 15mm 100mm CS7<br />
Humeral Head 40mm CS8<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong> 5
Fresh Osteochondral (FO) Grafts<br />
Items Canal Diameter <strong>Catalogue</strong> Number<br />
(Refrigerated)<br />
Femur Medial Condyle Varies FO1<br />
Femur Lateral Condyle Varies FO2<br />
Tibia Medial Plateu Varies FO3<br />
Tbia Lateral Plateu Varies FO4<br />
Knee Whole Varies FO5<br />
Talus Varies FO6<br />
Os Calcaneous Varies FO7<br />
Ankle Whole Varies FO8<br />
Shoulder Whole Varies FO9<br />
Elbow Whole Varies FO10<br />
Grafts For Spinal (SG) Applications<br />
Items Height X Width X Length <strong>Catalogue</strong> Number<br />
(Frozen)<br />
<strong>Catalogue</strong> Number<br />
(Lyophilized)<br />
Patella Wedge 15x13x33mm SGF1 SGL1<br />
Ilium Strip Tri-Cortical 15-25x10x65mm SGF2 SGL2<br />
Ilium Block Tri-Cortical 15-25x20x65mm SGF3 SGL3<br />
Iliac Crest Wedge<br />
Small 9-14x9x18-25mm SGF4<br />
SGL4<br />
Fibula/Radius/Ulna Cortical<br />
Segment<br />
Large 15-25x10x25-30mm<br />
Small 40-65mm<br />
Large 66-99mm<br />
Femoral Ring 5-25mm Height SGF6 SGL6<br />
SGF5<br />
SGL5<br />
CANCELLOUS BONE (CB) GRAFTS<br />
Items Volume <strong>Catalogue</strong> Number<br />
(Frozen)<br />
<strong>Catalogue</strong> Number<br />
(Lyophilized)<br />
Cancellous Ground Bone<br />
1-4mm<br />
Cancellous Ground Bone<br />
4-10mm<br />
5cc CBF1 CBL1<br />
15cc CBF2 CBL2<br />
20cc CBF3 CBL3<br />
30cc CBF4 CBL4<br />
40cc CBF5 CBL5<br />
60cc CBF6 CBL6<br />
90cc CBF7 CBL7<br />
15cc CBF8 CBL8<br />
20cc CBF9 CBL9<br />
30cc CBF10 CBL10<br />
40cc CBF11 CBL11<br />
60cc CBF12 CBL12<br />
90cc CBF13 CBL13<br />
6<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong>
Cortico-Cancellous (CC) Bone Grafts<br />
Items Volume <strong>Catalogue</strong> Number<br />
(Frozen)<br />
Cortico-Cancellous Ground Bone<br />
1-4mm<br />
Cortico-Cancellous Ground Bone<br />
4-10mm<br />
15cc CCF1 CCL1<br />
20cc CCF2 CCL2<br />
30cc CCF3 CCL3<br />
40cc CCF4 CCL4<br />
60cc CCF5 CCL5<br />
90cc CCF6 CCL6<br />
15cc CCF7 CCL7<br />
20cc CCF8 CCL8<br />
30cc CCF9 CCL9<br />
40cc CCF10 CCL10<br />
60cc CCF11 CCL11<br />
90cc CCF12 CCL12<br />
<strong>Catalogue</strong> Number<br />
(Lyophilized)<br />
Flexible Grafts (FG) For Sports Medicine Applications<br />
Items Minimum Length Of Tendon <strong>Catalogue</strong> Number<br />
(Frozen)<br />
Achillies Tendon With Bone Block 160mm FG1<br />
Patellar Tendon Whole With Bone Block 30mm (Width)X25mm(Length) FG2<br />
Patellar Tendon Preshaped With Bone Block 15mm (Width)X25mm(Length) FG3<br />
Patellar Tendon W/Quad. Tendon<br />
15mm (Width)X25mm(Length)<br />
FG4<br />
With Bone Block<br />
& 100mm (Quad. Length)<br />
Anterior Tibialis Tendon With Bone Block 230mm FG5<br />
Posterior Tibialis Tendon With Bone Block 230mm FG6<br />
Gracilis Tendon 230mM FG7<br />
Semi-Tendenous 230mm FG8<br />
Peroneus Longus Tendon 230mm FG9<br />
Bundled Tendons (Gracilis & Semi-T.) 230mm Each FG10<br />
Meniscus Whole With Bone Block Varies FG11<br />
Meniscus Medial With Bone Block Varies FG12<br />
Meniscus Lateral With Bone Block Varies FG13<br />
Fascia Lata 60mmx140mm FG14<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong> 7
Notes<br />
8<br />
<strong>Products</strong> <strong>and</strong> <strong>Services</strong> <strong>Catalogue</strong>
<strong>Mount</strong> <strong>Sinai</strong> <strong>Hospital</strong><br />
Joseph <strong>and</strong> Wolf Lebovic Health Complex<br />
539-600 University Avenue<br />
Toronto, Ontario, Canada M5G 1X5<br />
t 416-586-8870 201104586
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