Allograft Tissues
 

Reference list

  1. 1. Cassell GH. Infectious Causes of Chronic Inflammatory Diseases and Cancer. Emerging Infectious Diseases 4(3):475-487, 1998. Centers For Disease Control.
Products
Orthopedic Products
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CarboJetª Lavage
KineMatchª PFR
NaviProª Hip
NaviProª  Knee
NaviProª  Shoulder
Gemª Total Knee System
Option Hip System
Allograft Tissues
Neurosurgical/Spine Products
NeuroPro¨ Fixation System
Prestaª  Cervical Allograft
Allograft Tissues
Kinamed distributes a wide range of bone and soft tissue allografts supplied by Pacific Coast Tissue Bank. Tissues used in the following surgical specialties are available:
  • orthopedic surgery
  • spine surgery
  • neurosurgery
  • craniofacial surgery
  • plastic surgery
  • oral and maxillofacial surgery
  • urological surgery

Available Tissues
All tissues supplied are provided freeze-dried and sterilized using EtO. A partial list of the types of allograft tissues available includes:

  • bone dowels, rings, wedges and segments for spinal surgery;
  • mandibles for mandibular reconstruction;
  • bone chips, powders and matchsticks;
  • demineralized and perforated bone (US Patent No. 4,932,973) in rings, wedges and segments for spinal and orthopedic applications;
  • flexible Laminar Cortical Bone, demineralized and perforated (US Patent No. 4,932,973) for cranial reconstruction and spine surgery;
  • fascia lata for bladder suspension procedures;
  • other tissues available.

Contact us with your allograft requirements. All US deliveries made in two business days. Visa and MasterCard payment accepted.

Insuring Allograft Safety
Insuring absolute safety of all allograft tissues supplied is of supreme importance at Pacific Coast Tissue Bank (PCTB). This is accomplished with a series of carefully controlled steps beginning with donor screening and continuing throughout the tissue processing procedure. Only EtO sterilized materials are provided to insure maximum safety.

Donor Screening
Every donor undergoes thorough screening, starting with a donor history and family interview, to check for past disease conditions and high-risk social behavior. Any donor that does not meet these screening criteria is rejected.

Serologic testing is then conducted on each donor per standard US FDA mandated criteria including:

  • HIV-1 and HIV-2 Antibody
  • Hepatitis B Surface Antigen
  • Hepatitis C Antibody

Additional State of California required testing performed on each donor includes:

  • HTLV-1 and HTLV-2 Antibody
  • Syphilis RPR or VDRL

Although not mandated by regulation PCTB additionally performs the following tests:

  • HIV-1 DNA by PCR
  • HIV-1 P24 Antigen

Delipidization
Delipidization or defatting, performed with ether and ethanol, further increases the safety of the material in two ways. First, these solvents serve to inactivate viruses. Secondly, the defatting process provides for improved penetration of the EtO gas during the subsequent sterilization step. Finally, an additional benefit realized as a result of the defatting treatment, is the extraction of HLA antigens that could otherwise stimulate a host immune response. A host immune response, as often seen with fresh frozen bone, may result in fibrous encapsulation of the allograft and failure of the grafting procedure.

Sterilization
Most importantly, all PCTB allograft materials undergo sterilization by EtO gas using a laboratory validated protocol. This critical step is performed to maximize the safety, not only for the pathogens screened for in the rare instance of a false negative test result, but for all other possible viral and bacterial pathogens. With the constant discovery of new pathogens and the implication of known pathogens as causitive agents in many forms of chronic disease and cancer, this step insures maximum safety for the allograft recipient.1


 

Freeze-drying
Finally, freeze-drying, or lypholizing, allows for storage at room temperature and greatly improved shelf life. Studies have shown that freeze-drying does not adversely affect the bone induction qualities of bone allograft materials.

 

 

 

KINAMED INCORPORATED • 820 Flynn Road • Camarillo, CA 93012
Phone Toll-Free (800) 827-5775 •  (805) 384-2748 • Fax (805) 384-2792
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