Demineralized Bone Matrix (DBM) Allografts 22 DBM Chips 23 DBM Cancellous Block 23 DBM Strip 23 H-GENIN Putty 24 H-GENIN Crush-Mix 24

Transcription

1 Allograft Catalog

2 Table of Contents General Allograft Information 4 Welcome Letter 5 Introduction to International Biologics 6 Licenses and Accreditations 6 Donor Screening and Testing 7 Allograft Processing and Quality Assurance Statement 8 Traditional Allografts 9 Bicortical Dowel 10 Cloward Dowel (Bone Plug) 10 Cortical Strut 11 Cortical/Unicortical Strip (Matchstick) 11 Ilium Tricortical Strip 12 Iliac Crest Wedge 12 Femur Condyle 13 Femur Head 13 Femur Ring 13 Femur Shaft 13 Tibia Shaft 14 Tibia Strut (Plate) 14 Fibula Shaft 15 Fibula Ring 15 Humerus Head 16 Humerus Shaft 16 High Tibial Osteotomy (HTO) Wedge 17 Patella Block 17 Cancellous Block 18 Cancellous Cervical Block 18 Particulate Allografts 19 Cortical-Cancellous Chips 20 Cancellous Chips 20 Cancellous Cubes 21 Cancellous, Cortical, & Demineralized Cortical Powder 21 Demineralized Bone Matrix (DBM) Allografts 22 DBM Chips 23 DBM Cancellous Block 23 DBM Strip 23 H-GENIN Putty 24 H-GENIN Crush-Mix 24 2

3 Soft Tissue Allografts 25 Achilles Tendon 26 Patellar Tendon (BTB) 26 Quadriceps Tendon 26 Gracilis Tendon 26 Semitendinosus Tendon 27 Anterior Tibialis Tendon 27 Posterior Tibialis Tendon 27 Peroneus Longus Tendon 27 Fascia Lata 28 Meniscus 28 Spinal Allografts 29 Unicortical Cervical Allograft 30 Cortical-Cancellous Cervical Spacer 30 Cortical Cervical Spacer 30 Anterior Lumbar Interbody Fusion (ALIF) 31 Posterior Lumbar Interbody Fusion (PLIF) 31 Dental Allografts 32 Cancellous 33 Cortical/Cancellous (50/50) 33 Cortical (Mineralized/Demineralized Blend) 34 Cortical 34 Demineralized Cortical 34 Bone Pin 35 Bone Wrap 35 Unicortical Cancellous Platform 35 J Platform 35 Membrane & Barrier Allografts 36 AdMatrix 37 Pericardium Patch 37 Shipping and Storage of Allografts 38 Return Policy 38 Custom Requests & Special Orders 39 Private Label Services 39 3

4 General Allograft Information What is an allograft? An allograft is tissue that is recovered from a human donor and used to surgically repair damaged bones, joints, and tendons. Over 1,000,000 allografts are implanted each year. Why are allografts used? Because of inadequate amounts of autografts (a person s own bone or tissue) and the limited size and shape of a person s own bone, allografts are commonly used. Using an allograft will eliminate the need for a second operative site to recover autograft bone or tissue, reducing the risk of infection at a separate surgical site, and safeguard against pain and loss of function at or near the secondary site. Where do allografts come from? Each person has a choice as to whether or not to donate their organs and/or tissues. These donors are otherwise healthy individuals who experienced a sudden illness or accident which ultimately led to death. How safe are allografts? Preparing tissue for transplant begins with the removal of debris and organic matter. The tissue is then soaked in various solutions to prevent the transmission of bacteria and viruses. Processing and packaging are performed using aseptic techniques in environmentally monitored clean rooms to maintain biological integrity. Low-dose gamma radiation is used to terminally sterilize the tissues. The United States Food and Drug Administration (FDA) have regulated this field very closely since 1993 to ensure allograft safety. Over 1,000,000 allografts are implanted each year with a remarkable record of safety. 4

5 Welcome to International Biologics! I have had the great pleasure and privilege of serving as the Medical Director for International Biologics since its inception in In that capacity, I have experienced firsthand the challenges and rewards of establishing a new tissue bank and striving to build it into an industry leader in the manufacture of safe and effective allografts. I take pride in upholding International Biologics organizational mission: to honor the gift of tissue donation by providing safe and economical allograft tissue for an ever increasing number of clinical applications. As Medical Director, I hold the final authority to determine donor suitability based on medical records, autopsy results, and post-mortem laboratory tests. I ensure that every donor International Biologics processes meets the strict standards and regulations set forth by the American Association of Tissue Banks (AATB) and the United States Food and Drug Administration (FDA) to protect the health of the patients who receive our allografts, and the surgeons, nurses, and technicians who handle them. I hope that you will consider International Biologics products for all of your allograft tissue needs. If you have any questions concerning quality or process, please feel free to contact me or our Director, Quality Systems, Leah M. Poston, CTBS. Sincerely, Dr. S. Mitchell Harman, M.D., Ph. D. Dr. S. Mitchell Harman, M.D., Ph. D. Captain, USPHS, Retired 5

6 Introduction International Biologics (IB) opened its doors in the spring of 2007 in Scottsdale, Arizona, the Valley of the Sun. This facility manufactures a wide range of allografts for various clinical applications. IB s processing facility includes ISO Class 1000 and ISO Class 100 clean rooms, and specialized equipment capable of crafting traditional allografts and precision specialty allografts. The IB staff of highly trained surgical technicians, certified tissue bank specialists, certified sterile processing and distribution technicians, and CNC operators maintains the highest standards of aseptic technique throughout each step of the manufacturing process, from receipt and storage of donor tissue to the final packaging and distribution of finished allografts. Licenses and Accreditations Accredited by the American Association of Tissue Banks Registered with the United States Food and Drug Administration Licensed by the State of Florida Agency for Health Care Administration Licensed by the State of New York Department of Health Licensed by the State of California Department of Public Health Licensed by the State of Oregon Health Authority Licensed by the State of Maryland Department of Health and Mental Hygiene Registered with Health Canada 6

7 Donor Screening and Testing All donor recovery agencies engaged by IB comply with applicable local, state, and federal laws, regulations, and standards. A potential donor is thoroughly evaluated by both the recovery agency and IB. A preliminary screening and evaluation process is completed by the recovery agency prior to tissue recovery. Such screening includes a medical and social history interview as well as a physical assessment. An extensive review of all relevant medical records is conducted by the IB Quality Systems Department to ensure suitability for processing and distribution of donated tissue. All donors and donor tissue processed at IB have been subjected to biological and medical screening to guard against the possibility of recipient exposure to, or transmission of, communicable diseases or exclusionary medical conditions. These screening procedures are performed in accordance with standards, regulations, statutes and/or directives of the American Association of Tissue Banks (AATB), the U.S. Food and Drug Administration (FDA), State Licensing Agencies, the European Union, and Health Canada. Additional communicable disease testing and screening in excess of the requirements by the AATB and FDA may have also been completed. Such data has been reviewed by the Medical Director (licensed physician) of International Biologics and the allografts have been deemed suitable for transplantation. Communicable disease testing on a qualified donor blood sample is performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). All the required communicable disease tests listed below must be found to be nonreactive or negative: -Human Immunodeficiency Virus (HIV) HIV-1/2 Antibodies HIV-1/2-Ab Nucleic Acid Test for HIV-1 RNA HIV-1 NAT -Hepatitis B Virus (HBV) HBV Surface Antigen HBsAg HBV Core Antibody (IgG & IgM) HBcAb Nucleic Acid Test for HBV DNA (if applicable) HBV NAT -Hepatitis C Virus (HCV) HCV Antibody HCVAb Nucleic Acid Test for HCV RNA HCV NAT -Syphilis Rapid Plasma Reagin Screen RPR* Or T. Pallidum IgG T. pallidum IgG *Tissues from a donor whose blood specimen is unsuitable for the non-treponemal screening assay, such as the RPR test, or with a reactive result from the non-treponemal screening assay, are cleared for transplantation use only when the result from the treponemal-specific (confirmatory) assay is nonreactive. Non-required screening tests for exposure to other viruses or parasites such as those listed below for may have been performed on the donor by other agencies involved in the donation process. A negative/nonreactive result is not required for these tests; however, all donors are evaluated on a case-by-case basis by the Medical Director. -HTLV-I/II Antibody -Cytomegalovirus -Epstein Barr Virus -Toxoplasma gondii -Trypanosoma cruzi HTLV-I/II-Ab CMV Ab (IgG & IgM) EBV Ab (IgG & IgM) Toxoplasma Ab (IgG & IgM) T. cruzi Ab (IgG & IgM) 7

8 Allograft Processing The processing steps utilized at International Biologics are designed to maximize the gift of donation, while assuring the safety of the end-user and transplant recipient by providing safe and sterile allografts. Each stage of the process has been designed and validated to ensure patient safety. All tissue is processed in certified ISO Class 1000 and Class 100 clean rooms Aseptic technique is maintained throughout the entire process as outlined by Association of Operating Room Nurses (AORN) standards An anti-bacterial soak is employed to reduce bioburden Terminal sterilization with low-dose gamma radiation (15.8 to 28.0 kgy) All tissue is tracked from recovery through testing, processing, packaging, and distribution Quality Assurance Pre-processing and post-processing quality assurance and quality control reviews are performed on all donated tissues. Each donor is approved by International Biologics Medical Director to ensure compliance with donor acceptance criteria prior to release. International Biologics policies and procedures for donor tracking, documentation, tissue processing, allograft packaging, and distribution activities are designed and executed in compliance with current FDA regulations and AATB standards, ensuring safe, high-quality allografts for transplantation. 8

9 Traditional Allografts 9

10 Bicortical Dowel 212 Bicortical Dowel D= 12mm L= 5-25mm 214 Bicortical Dowel D= 14mm L= 5-25mm 216 Bicortical Dowel D= 16mm L= 5-25mm 218 Bicortical Dowel D= 18mm L= 5-25mm Source: Ilium Details: A bicortical dowel is cylindrical, dense cancellous bone with a cortical face at both ends. Common Applications: Spinal fusions and general orthopaedic reconstructions Cloward Dowel (Bone Plug) 206 Cloward Dowel D= 12mm L= 5-25mm 207 Cloward Dowel D= 14mm L= 5-25mm 208 Cloward Dowel D= 16mm L= 5-25mm 209 Cloward Dowel D= 18mm L= 5-25mm Source: Ilium, proximal and distal ends of the tibia and femur Details: A cloward dowel is cylindrical, dense cancellous bone with a cortical face on one end Common Applications: Spinal fusions and general orthopaedic reconstructions 10

11 Cortical Strut 200 Cortical Strut W< 15mm L= mm 201 Cortical Strut 2-pack W= 15mm L= 100mm 202 Cortical Strut W= 20mm L= 20mm 203 Cortical Strut W= 20mm L= 40mm 204 Cortical Strut W= 20mm L= 80mm 205 Cortical Strut W= 20mm L= 100mm Source: Tibia and femur Details: A cortical strut is a long, thin segment of dense cortical bone Common Applications: Spinal fusions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions Cortical/Unicortical Strip (Matchstick) 309 Unicortical Strip 5-pack L= 5mm W= 5mm H= 50mm 310 Cortical Strip 5-pack L= 5mm W= 5mm H= 50mm 311 Cortical Strip 10-pack L= 5mm W= 5mm H= 50mm Source: Ilium, femur, and tibia Details: A cortical/unicortical strip is a segment of bone with either one cortical face and a cancellous base, or all cortical Common Applications: Spinal fusions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions 11

12 Ilium Tricortical Strip 302 Ilium Tricortical Strip Variable (L x W x H) Source: Ilium Details: An ilium tricortical strip is a section of the iliac crest including anterior, superior, and posterior cortical faces; with the lateral, medial and inferior faces cut to expose the cancellous core Common Applications: Spinal fusions and general orthopaedic reconstructions Iliac Crest Wedge 303 Iliac Crest Wedge H 10mm L, W, T1, T2 = Variable 304 Iliac Crest Wedge H= 11-13mm L, W, T1, T2 = Variable 305 Iliac Crest Wedge H= 14-17mm L, W, T1, T2 = Variable 306 Iliac Crest Wedge H 18mm L, W, T1, T2 = Variable Source: Ilium Details: An iliac crest wedge is a section of the iliac crest including anterior, superior, and posterior cortical faces; with the lateral, medial and inferior faces cut to expose the cancellous core Common Applications: Spinal fusions and general orthopaedic reconstructions 12

13 Femur Condyle 520 Femur Condyle, Whole Variable (W x L) 522 Femur Condyle, Hemi Variable (W x L) Source: Femur Details: A femur condyle is a section of the distal end of the femur Common Applications: General orthopaedic reconstructions Femur Head 550 Femur Head Variable (D) Source: Femur Details: A femur head is a section of the proximal end of the femur Common Applications: Hip revisions and general orthopaedic reconstructions Femur Ring 570 Femur Ring Variable (H x D) Source: Femur Details: A femur ring is a cross-section of the femur shaft Common Applications: Spinal fusions and general orthopaedic reconstructions Femur Shaft 560 Femur Shaft, Small Variable (W x L) 562 Femur Shaft, Large Variable (W x L) 564 Femur Shaft, Bisected Variable (W x L) Source: Femur Details: A femur shaft is the center segment between the femur head and the femur condyle Common Applications: General orthopaedic reconstructions 13

14 Tibia Shaft 585 Tibia Shaft, Segment Variable (D x L) 586 Tibia Shaft, Bisected Variable (W x L) Source: Tibia Details: A tibia shaft is a segment of dense cortical bone from the tibia between the proximal and distal ends Common Applications: General orthopaedic reconstructions Tibia Strut (Plate) 587 Tibia Strut Variable (W x L) Source: Tibia Details: A tibia strut is a flat plate of cortical bone from the tibial shaft Common Applications: General orthopaedic reconstructions 14

15 Fibula Shaft 604 Fibula Shaft, Small W= Variable L 45mm 605 Fibula Shaft, Large W= Variable L 46mm 606 Fibula Shaft, Bisected Variable (W x L) Source: Fibula Details: A fibula shaft is a section of the fibula between the proximal and distal ends Common Applications: Spinal fusions and general orthopaedic reconstructions Fibula Ring 607 Fibula Ring Variable (H x D) Source: Fibula Details: A fibula ring is a cross-section of the fibula shaft Common Applications: Spinal fusions and general orthopaedic reconstructions 15

16 Humerus Head 654 Humerus Head Variable (D) Source: Humerus Details: A humerus head is a section of the proximal end of the humerus Common Applications: General orthopaedic reconstructions Humerus Shaft 655 Humerus Shaft Variable (W x L) Source: Humerus Details: A humerus shaft is a section of the humerus between the proximal and distal ends Common Applications: General orthopaedic reconstructions 16

17 High Tibial Osteotomy (HTO) Wedge 508 HTO Wedge H= 8mm 511 HTO Wedge H= 11mm 516 HTO Wedge H= 16mm Source: Tibia Details: An HTO wedge is a cross-section of the proximal end of the tibia, with a thick medial edge and a thin lateral edge Common Applications: Podiatric and general orthopaedic reconstructions Patella Block 590 Patella Block Variable (W x L x H) Source: Patella Details: A patella block is a section of the patella cut medially and laterally to expose the cancellous core Common Applications: Spinal fusions and general orthopaedic reconstructions 17

18 Cancellous Block 130 Cancellous Block H 10mm W 10mm L 30mm 131 Cancellous Block H= 11mm W= 11mm L= 30mm 133 Cancellous Block H= 13mm W= 13mm L= 30mm 135 Cancellous Block H= 15mm W= 15mm L= 30mm Source: Proximal and distal ends of long bones, calcaneus, and talus Details: Cancellous blocks are cuboid pieces of cancellous bone Common Applications: Spinal fusions and general orthopaedic reconstructions Cancellous Cervical Block 405 Cancellous Cervical Block 5mm x 11mm x 11mm 406 Cancellous Cervical Block 6mm x 11mm x 11mm 407 Cancellous Cervical Block 7mm x 11mm x 11mm 408 Cancellous Cervical Block 8mm x 11mm x 11mm 409 Cancellous Cervical Block 9mm x 11mm x 11mm 410 Cancellous Cervical Block 10mm x 11mm x 11mm Source: Distal and proximal ends of the femur and tibia Details: Cancellous cervical blocks are precision milled pieces of cancellous bone Common Applications: Spinal reconstructions and applications, general orthopaedic reconstructions 18

19 Particulate Allografts 19

20 Cortical-Cancellous Chips (all sizes in mm and cc) 101 Cortical-Cancellous Chips 1-4mm / 15cc 102 Cortical-Cancellous Chips 1-4mm / 30cc 103 Cortical-Cancellous Chips 1-4mm / 45cc 104 Cortical-Cancellous Chips 1-4mm / 60cc 111 Cortical-Cancellous Chips 4-10mm / 15cc 112 Cortical-Cancellous Chips 4-10mm / 30cc 113 Cortical-Cancellous Chips 4-10mm / 45cc 114 Cortical-Cancellous Chips 4-10mm / 60cc Source: Long bones, calcaneus, and talus Details: Cortical-cancellous chips are milled and sieved pieces of cortical and cancellous bone Common Applications: Spinal fusions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions Cancellous Chips (all sizes in mm and cc) 138 Cancellous Chips 1-4mm / 10cc 140 Cancellous Chips 1-4mm / 15cc 142 Cancellous Chips 1-4mm / 30cc 144 Cancellous Chips 1-4mm / 45cc 146 Cancellous Chips 1-4mm / 60cc 148 Cancellous Chips 1-4mm / 90cc 150 Cancellous Chips 4-10mm / 15cc 152 Cancellous Chips 4-10mm / 30cc 154 Cancellous Chips 4-10mm / 45cc 156 Cancellous Chips 4-10mm / 60cc 158 Cancellous Chips 4-10mm / 90cc Source: Proximal and distal ends of long bones, calcaneus, and talus Details: Cancellous chips are milled and sieved pieces of cancellous bone Common Applications: Spinal fusions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions 20

21 Cancellous Cubes (all sizes in mm and cc) 170 Cancellous Cubes 3-5mm / 15cc 172 Cancellous Cubes 3-5mm / 30cc 174 Cancellous Cubes 3-5mm / 45cc 176 Cancellous Cubes 3-5mm / 60cc Source: Proximal and distal ends of long bones, calcaneus, and talus Details: Cancellous cubes are milled and sieved pieces of cancellous bone Common Applications: Spinal fusions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions Cortical & Cancellous Powder (all sizes in µm and cc) 160 Cancellous Powder µm / 5cc 161 Cancellous Powder µm / 10cc 162 Cancellous Powder µm / 15cc 163 Cortical Powder µm / 5cc 164 Cortical Powder µm / 10cc 165 Cortical Powder µm / 15cc 166 Demineralized Cortical Powder µm / 5cc 167 Demineralized Cortical Powder µm / 10cc 168 Demineralized Cortical Powder µm / 15cc Source: Long bones, calcaneus, and talus Details: Cortical and cancellous powder is ground and sieved pieces of cortical and cancellous bone Common Applications: Spinal fusions, podiatric reconstructions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions 21

22 Demineralized Bone Matrix (DBM) Allografts 22

23 Demineralized Bone Matrix (DBM) Chips (all sizes in cc) 816 DBM Cancellous Chips 0.5cc 817 DBM Cancellous Chips 1cc 806 DBM Cancellous Chips 2.5cc 807 DBM Cancellous Chips 5cc 808 DBM Cancellous Chips 10cc Source: Proximal and distal ends of long bones, calcaneus, and talus Details: DBM cancellous chips are milled, demineralized pieces of cancellous bone Common Applications: Spinal fusions, podiatric reconstructions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions Demineralized Bone Matrix (DBM) Cancellous Block 800 DBM Cancellous Block L= 8mm W=8mm H=8mm 801 DBM Cancellous Block L= 10mm W=10mm H=10mm 802 DBM Cancellous Block L= 12mm W=12mm H=12mm 809 DBM Cancellous Block L= 13mm W=13mm H=13mm 803 DBM Cancellous Block L= 14mm W=14mm H=14mm 810 DBM Cancellous Block L= 15mm W=15mm H=15mm Source: Proximal and distal ends of long bones, calcaneus, and talus Details: DBM Cancellous blocks are cuboid pieces of demineralized cancellous bone Common Applications: Spinal fusions and general orthopaedic reconstructions Demineralized Bone Matrix (DBM) Strip DBM Strip, Small L= 30-40mm DBM Strip, Medium L= 41-50mm DBM Strip, Large L 51mm Source: Proximal and distal ends of long bones, calcaneus, and talus Details: DBM cancellous strips are long, thin sheets of demineralized cancellous bone Common Applications: Spinal fusions and general orthopaedic reconstructions 23

24 H-GENIN Putty (all sizes in cc) JHG-007P H-GENIN Putty 0.7cc JHG-01P H-GENIN Putty 1cc JHG-02P H-GENIN Putty 2.5cc JHG-05P H-GENIN Putty 5cc JHG-10P H-GENIN Putty 10cc Source: Cortical bone Details: H-GENIN putty is a mixture of finely ground, demineralized cortical bone powder and gelatin Common Applications: Spinal fusions, podiatric reconstructions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions H-GENIN Crush Mix (all sizes in cc) JHG-01C H-GENIN Crush Mix 1cc JHG-02C H-GENIN Crush Mix 2.5cc JHG-05C H-GENIN Crush Mix 5cc JHG-10C H-GENIN Crush Mix 10cc Source: Cortical and cancellous bone Details: H-GENIN crush-mix is a mixture of finely ground, demineralized cortical bone powder and gelatin and crushed cancellous bone Common Applications: Spinal fusions, podiatric reconstructions, oral/maxillofacial reconstructions, and general orthopaedic reconstructions 24

25 Soft Tissue Allografts 25

26 Achilles Tendon 901 Achilles Tendon Variable (TL x TW x BL x BW x BT) Achilles Tendon, Hemi Variable (TL x TW x BL x BW x BT) Source: Achilles and calcaneus Preservation Method: Frozen, must be stored at -40 C or colder Details: An Achilles tendon with a block of the calcaneus attached to the distal end Common Applications: Reconstruction of rotator cuffs, knee ligaments, and Achilles tendon repair Patellar Tendon (BTB) 902 BTB, Hemi Variable (TL1 x TL2 x TW) 903 BTB, Whole Variable (TL1 x TL2 x TW) Source: Tibia, patella, patellar ligament Preservation Method: Frozen, must be stored at -40 C or colder Details: A patellar tendon with a tibial bone block, distal, and a patella bone block, proximal Common Applications: Orthopaedic reconstructions, knee reconstructions Quadriceps Tendon 911 Quadriceps Tendon, Variable (TL x TW x BL x BW x BT) Whole Quadriceps Tendon, Hemi Variable (TL x TW x BL x BW x BT) Source: Quadriceps tendon Preservation Method: Frozen, must be stored at -40 C or colder Details: A quadriceps tendon with bone block Common Applications: Orthopaedic reconstructions, knee reconstructions Gracilis Tendon 904 Gracilis Tendon Variable (Double Loop x L) Source: Gracilis tendon Preservation Method: Frozen, must be stored at -40 C or colder Details: A gracilis tendon without bone block Common Applications: Orthopaedic reconstructions, knee reconstructions 26

27 Semitendinosus Tendon 905 Semitendinosus Tendon Variable (Double Loop x L) Source: Semitendinosus tendon Preservation Method: Frozen, must be stored at -40 C or colder Details: A semitendinosus tendon without bone block Common Applications: Orthopaedic reconstructions, knee reconstructions Anterior Tibialis Tendon 907 Anterior Tibialis Tendon Variable (Double Loop x L) Source: Anterior Tibialis tendon Preservation Method: Frozen, must be stored at -40 C or colder Details: An anterior tibialis tendon without bone block Common Applications: Orthopaedic reconstructions, knee reconstructions Posterior Tibialis Tendon 908 Posterior Tibialis Tendon Variable (Double Loop x L) Source: Posterior Tibialis tendon Preservation Method: Frozen, must be stored at -40 C or colder Details: A posterior tibialis tendon without bone block Common Applications: Orthopaedic reconstructions, knee reconstructions Peroneus Longus Tendon 909 Peroneus Longus Tendon Variable (Double Loop x L) Source: Peroneus Longus tendon Preservation Method: Frozen, must be stored at -40 C or colder Details: A peroneus longus tendon without bone block Common Applications: Orthopaedic reconstructions, knee reconstructions 27

28 Fascia Lata 700 Fascia Lata, Small W= Variable L= mm 702 Fascia Lata, Medium W= Variable L= mm 704 Fascia Lata, Large W= Variable L 140mm Source: Lateral surface of the upper thigh, Tensor Fascia Lata Preservation Method: Frozen, must be stored at -40 C or colder Details: A fascia lata is a sheet or strip of fibrous connective tissue Common Applications: Sports medicine, neurological, cardiac, urological, and cosmetic applications Meniscus Size & Measurements 912 Right Meniscus, Whole Variable (L x W x T) Right Meniscus, Medial Variable (L x W x T) Right Meniscus, Lateral Variable (L x W x T) 913 Left Meniscus, Whole Variable (L x W x T) Left Meniscus, Medial Variable (L x W x T) Left Meniscus, Lateral Variable (L x W x T) Source: Proximal Tibia Preservation Method: Frozen, must be stored at -40 C or colder Details: A whole right or left meniscus with tibial bone block Common Applications: Orthopaedic reconstructions, knee reconstructions 28

29 Spinal Allografts 29

30 Unicortical Cervical Allograft 945 Unicortical Cervical Allograft 5mm 946 Unicortical Cervical Allograft 6mm 947 Unicortical Cervical Allograft 7mm 948 Unicortical Cervical Allograft 8mm 949 Unicortical Cervical Allograft 9mm 950 Unicortical Cervical Allograft 10mm Source: Ilium Details: Unicortical Cervical Allografts are precision milled 16±1mm square blocks cut from the iliac crest Common Applications: Spinal reconstructions and applications Cortical-Cancellous Cervical Spacer 965 Cortical-Cancellous Cervical Spacer 5mm 5mm x 11mm x 14mm 966 Cortical-Cancellous Cervical Spacer 6mm 6mm x 11mm x 14mm 967 Cortical-Cancellous Cervical Spacer 7mm 7mm x 11mm x 14mm 968 Cortical-Cancellous Cervical Spacer 8mm 8mm x 11mm x 14mm 969 Cortical-Cancellous Cervical Spacer 9mm 9mm x 11mm x 14mm 970 Cortical-Cancellous Cervical Spacer 10mm 10mm x 11mm x 14mm Source: Femur and tibia Preservation Method: Saline, must be stored at ambient temperature Details: Cortical-cancellous cervical spacers are precision milled cortical grafts with a cancellous plug in the center, with textured surfaces Common Applications: Spinal reconstructions and applications Cortical Cervical Spacer 975 Cortical Cervical Spacer 5mm 5mm x 11mm x 14mm 976 Cortical Cervical Spacer 6mm 6mm x 11mm x 14mm 977 Cortical Cervical Spacer 7mm 7mm x 11mm x 14mm 978 Cortical Cervical Spacer 8mm 8mm x 11mm x 14mm 979 Cortical Cervical Spacer 9mm 9mm x 11mm x 14mm 980 Cortical Cervical Spacer 10mm 10mm x 11mm x 14mm Source: Femur and tibia Preservation Method: Saline, must be stored at ambient temperature Details: Cortical cervical spacers are precision milled cortical grafts with textured surfaces Common Applications: Spinal reconstructions and applications 30

31 Anterior Lumbar Interbody Fusion (ALIF) ALIF 8 12mm 12mm x 27mm ALIF 8 14mm 14mm x 27mm ALIF 8 16mm 16mm x 27mm ALIF 8 18mm 18mm x 27mm ALIF 8 20mm 20mm x 27mm ALIF 8 22mm 22mm x 27mm ALIF 12 12mm 12mm x 27mm ALIF 12 14mm 14mm x 27mm ALIF 12 16mm 16mm x 27mm ALIF 12 18mm 18mm x 27mm ALIF 12 20mm 20mm x 27mm ALIF 12 22mm 22mm x 27mm Source: Femur Preservation Method: Frozen, must be stored at -40 C or colder; Available lyophilized upon request Details: ALIFs are precision milled cortical grafts with 8 of 12 lordosis between top and bottom, hollow center and textured surfaces Common Applications: Spinal reconstructions and applications Posterior Lumbar Interbody Fusion (PLIF) 1007 PLIF 7mm 7mm x 23mm x 9mm 1009 PLIF 9mm 9mm x 23mm x 9mm 1011 PLIF 11mm 11mm x 23mm x 9mm 1013 PLIF 13mm 13mm x 23mm x 9mm 1015 PLIF 15mm 15mm x 23mm x 9mm Source: Femur Preservation Method: Saline, must be stored at ambient temperature Details: PLIFs are precision milled cortical grafts with textured surfaces Common Applications: Spinal reconstructions and applications 31

32 Dental Allografts 32

33 Cancellous (all sizes in µm and cc) Cancellous 250µm µm (1mm) 0.7cc Cancellous 250µm µm (1mm) 0.25cc Cancellous 250µm µm (1mm) 0.5cc Cancellous 250µm µm (1mm) 1cc Cancellous 250µm µm (1mm) 2cc Cancellous 250µm µm (1mm) 5cc Cancellous 500µm µm (1mm) 0.7cc Cancellous 500µm µm (1mm) 0.25cc Cancellous 500µm µm (1mm) 0.5cc Cancellous 500µm µm (1mm) 1cc Cancellous 500µm µm (1mm) 2cc Cancellous 500µm µm (1mm) 5cc Source: Long bones, calcaneus, and talus Details: Cancellous for dental is cut, milled cancellous bone particulate Common Applications: Oral/maxillofacial reconstructions Cortical-Cancellous (50/50) (all sizes in µm and cc) Cortical-Cancellous 250µm µm (1mm) 0.25cc Cortical-Cancellous 250µm µm (1mm) 0.5cc Cortical-Cancellous 250µm µm (1mm) 1cc Cortical-Cancellous 250µm µm (1mm) 2cc Cortical-Cancellous 250µm µm (1mm) 2.5cc Cortical-Cancellous 250µm µm (1mm) 5cc Cortical-Cancellous 500µm µm (1mm) 0.25cc Cortical-Cancellous 500µm µm (1mm) 0.5cc Cortical-Cancellous 500µm µm (1mm) 1cc Cortical-Cancellous 500µm µm (1mm) 2cc Source: Long bones, calcaneus, and talus Details: Cortical-cancellous (50/50) for dental is cut, milled cortical and cancellous bone particulate Common Applications: Oral/maxillofacial reconstructions 33

34 Cortical (Mineralized/Demineralized Blend) (all sizes in µm and cc) Cortical (Min/Demin Blend) 250µm µm (1mm) 0.5cc Cortical (Min/Demin Blend) 250µm µm (1mm) 0.7cc Cortical (Min/Demin Blend) 250µm µm (1mm) 1cc Cortical (Min/Demin Blend) 250µm µm (1mm) 2cc Source: Long bones, calcaneus, and talus Details: Cortical (mineralized 70%, demineralized 30%) for dental is cut, milled cortical bone particulate Common Applications: Oral/maxillofacial reconstructions Cortical (all sizes in µm and cc) Cortical 250µm µm (1mm) 0.25cc Cortical 250µm µm (1mm) 0.5cc Cortical 250µm µm (1mm) 0.7cc Cortical 250µm µm (1mm) 1cc Cortical 250µm µm (1mm) 2cc Cortical 500µm µm (1mm) 0.25cc Cortical 500µm µm (1mm) 0.5cc Cortical 500µm µm (1mm) 0.7cc Cortical 500µm µm (1mm) 1cc Cortical 500µm µm (1mm) 2cc Source: Long bones, calcaneus, and talus Details: Cortical for dental is cut, milled cortical bone particulate Common Applications: Oral/maxillofacial reconstructions Cortical Demineralized (all sizes in µm and cc) Cortical Demin 500µm µm (1mm) 0.25cc Cortical Demin 500µm µm (1mm) 0.5cc Cortical Demin 500µm µm (1mm) 0.7cc Cortical Demin 500µm µm (1mm) 1cc Cortical Demin 500µm µm (1mm) 2cc Source: Long bones, calcaneus, and talus Details: Cortical demineralized for dental is cut, milled cortical bone particulate Common Applications: Oral/maxillofacial reconstructions 34

35 Bone Pin Cortical Bone Pin 2mm x 3mm Source: Long bones Details: Cortical bone pins are long, thin pieces of cortical bone Common Applications: Oral/maxillofacial reconstructions Bone Wrap Cortical Bone Wrap 15mm x 25mm Cortical Bone Wrap 15mm x 35mm Source: Long bones Details: Cortical bone wraps are thin sheets of cortical bone Common Applications: Oral/maxillofacial reconstructions Unicortical Cancellous Platform Unicortical Cancellous Platform 9mm x 12mm Unicortical Cancellous Platform 9mm x 15mm Source: Long bones, calcaneus, and talus Details: Unicortical cancellous platforms are cut pieces of cancellous bone with one cortical face Common Applications: Oral/maxillofacial reconstructions J Platform J Platform 10mm J Platform 15mm Source: Ilium Details: J Platforms are cut pieces of cancellous bone with cortical bone on one side Common Applications: Oral/maxillofacial reconstructions 35

36 Membrane & Barrier Allografts 36

37 AdMatrix (all sizes in cm and mm) ADM AdMatrix 0.1 XS L= 1cm W= 1cm T= 0.1mm ADM AdMatrix 0.1 S L= 2cm W= 2cm T= 0.1mm ADM AdMatrix 0.1 M L= 4cm W= 4cm T= 0.1mm ADM AdMatrix 0.1 L L= 4cm W= 6cm T= 0.1mm ADM AdMatrix 0.25 S L= 2cm W= 2cm T= 0.25mm ADM AdMatrix 0.25 M L= 4cm W= 4cm T= 0.25mm ADM AdMatrix 0.25 L L= 4cm W= 6cm T= 0.25mm ADM AdMatrix 1.5 XL L= 8cm W= 16cm T=1.5mm ADM AdMatrix 1.5 XXL L= 16cm W= 20cm T=1.5mm Source: Skin Preservation Method: Frozen, must be stored at -40 C or colder Details: Decellularized dermal matrix Common Applications: Oral/maxillofacial reconstructions, Wound care Pericardium Patch 710 Pericardium Patch XS W= 10mm L= 10mm 711 Pericardium Patch S W= 15mm L= 20mm 712 Pericardium Patch M W= 20mm L= 20mm 713 Pericardium Patch L W= 20mm L= 30mm 714 Pericardium Patch XL W= 40mm L= 60mm Source: Pericardium Preservation Method: Frozen, must be stored at -40 C or colder Details: Sections of the pericardium Common Applications: Neurological, cardiac, and periodontal applications 37

38 Shipping and Storage of Allografts Freeze-dried allografts and allografts in saline are shipped in corrugated cardboard boxes. Frozen allografts are shipped on dry ice, to maintain a temperature of -40 C or colder, in qualified, validated thermal shipping containers. All allografts are sent via Best-Way utilizing commercial and private couriers. Please contact your Account Representative to discuss your specific needs. Freeze-dried allografts and allografts in saline must be stored at ambient temperature (15 C to 27 C), not frozen or refrigerated. Frozen allografts must be stored at or below -40 C; short-term storage of -20 C to -40 C may be utilized for up to six (6) months, if necessary. Allograft Return Policy In order to protect the integrity of our allografts, International Biologics will not accept product returns, except under the most stringent conditions. Please contact your Account Representative regarding any and all product returns. If a return is approved, a Return Authorization (RA) number issued by IB is required. For damaged items, IB, at the option of the customer, will replace the product(s) or issue a credit. All non-defective item returns, which are accepted by IB, may be subject to a 25% restocking fee. 38

39 Custom Requests and Special Orders Custom allografts may be discussed with your Account Representative at any time. International Biologics routinely works with customers to provide custom allografts to meet unique surgical needs. IB may also provide various bone and soft tissue allografts which are not featured in this catalog as a special order. These special requests may not be readily available in current inventory; but, upon request, may be produced. Please contact your Account Representative to discuss your specific needs. Please allow a minimum of 6 8 weeks for any custom request or special order. Private Label Services International Biologics offers private label services for custom, proprietary allografts. Private labeling can offer your product: Differentiation between your products and those of competitors Development of brand loyalty Pricing flexibility Experienced IB staff at every step IB s QA/QC processes to ensure compliance with FDA Regulations and AATB Standards And much more Please contact your Account Representative to discuss this option. 39

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