Bone Bank Allografts®

The options for surgical musculoskeletal repair continue to expand and a growing number of surgeons around the world continue to choose bone and soft tissue allografts as a safe, effective and convenient surgical option that yields unparalleled results for patients. CytoVive® is proud to offer Bone Bank Allografts industry leading allograft procurement and processing to our esteem clients and their valued patients.

Proprietary Allograft Processing 

Bone Bank Allograft's proprietary GraftCleanse® tissue cleansing method includes both chemical and physical tissue cleaning procedures to reduce the bone marrow and lipid element associated with normal human tissue. Processing includes closely controlled exposure to freeze/thaw cycles for superior tissue preservation. Allograft tissues are aseptically handled and sterilized under a scientifically validated sterilization method used to maintain a Sterility Assurance Level (SAL) of 10   in accordance with ISO 11137. This Validated process is designed to to protect the biomechanical properties of each allograft and reduce the risk of bacterial disease transmission. 

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Certified Laboratory Testing

In accordance with FDA Regulation and AATB standards, Donor specimens are collected and sent to an independent laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to test for the following infectious diseases:​

  • Human Immunodeficiency Virus Type I Ab

    • HIV I Antibody​

    • HIV I Ultrio

  • Human Immunodeficiency Virus Type II Ab

    • HIV II Antibody​

  • Human T-Lymphocyte Virus Type I (optional)​

    • HLTV I Antibody​

  • Human T-Lymphocyte Virus Type I (optional)​

    • HLTV I Antibody​

  • Hepatitis B Virus ​

    • HBc Antibody (total)​

    • HBV Ultrio

    • HBs Antigen

  • Hepatitis C Virus

    • HCV Antibody​

    • HCV Ultrio

  • ​Syphilis​​

    • Rapid Plasma Reagin Test​

    • FTA Confirmation

    • CMV IgG, CMV IgM (optional)

  • WNV RNA Screen, PCR on all living donors​

    • Recovery and/or Pre-Processing Bioburden Cultures​

Bone Bank Allograft Medical Directors review and evaluate all relevant medical records, screening and recovery documents for each donor to determine the eligibility status for transplant. 

Sterile Packaging

Extreme care is taken to ensure that donor tissues are recovered, processed and packaged appropriately so that the donor gift materializes in the most beneficial way for the transplant recipients. Bone Bank Allografts and CytoVive believe that the best way to honor donors wishes is to maximize the number of lives touched and forever enhanced by their generous contribution.

Sterigraft® bone and soft tissue allografts are packaged with extreme care to preserve the validated sterile nature of the tissues. The following details outline packaging advantages: 

  • Double Tyvek pouches and easy to read labeling

  • Outer package which provides a durable moisture barrier designed to accommodate both ultra-low and ambient temperature storage

  • Sterile inner pouch designed for easy delivery to the sterile field 

  • Terminal sterilization of product in its final packaging 

  • Validated three or five year expiration dating

  • Included product insert which provides details regarding donor screening, testing, and tissue processing.

  • Transplant record and multiple tissue ID barcode labels for operating room staff

  • Sterigraft® box allows for convenient stacking and storage

Quality Assurance

Bone Bank Allograft's donor tracking, documentation, tissue processing, allograft packaging, storage and shipping processes ensure the availability of safe, high quality allografts. A three-level pre-processing review is performed by our highly trained Quality Assurance staff and Medical Directors. The follow items are carefully reviewed and documented: 

  • Donor qualification

  • Medical/behavioral risk profile

  • Review of consent/authorization to recover tissues for transplantation

  • Review of recovery process/ time frames/reconciliation of refrigeration times/recovery site assessment/recovery sequence

  • Completion of recovery record

  • Receipt/reconciliation of tissue recovered

  • Supplies materials used in recovery/lot numbers and expiration dates

  • Blood sample assessment/qualification

  • Infectious disease testing results

  • Procurement microbiology results

  • Information sharing with other agencies who participated in recovery or receipt of recovered tissues

  • Pathology/autopsy results if performed

  • Tissue receipt records

    • Verification of Shipment parameters​

    • Reconciliation of tissues shipped vs. received

  • Processing Records​

    • SOP requirements have been met​

    • Supplies used

    • Visual product/packaging inspection

    • Traceability of tissues received

    • Irradiation sterilization parameters

    • Residual Moisture results acceptable

  • Completion of Quality Assurance investigations​

  • Completion of Production technical review

  • Inventory data entry

  • Final labeling

Our Processing Partner Facility

Bone bank Allografts has a state of the art human tissue processing center located in San Antonio, Texas. This state of the art facility was designed and built for compliance with environmental condition requirements for handling human tissues. All human tissue are handled in a cleanroom environment. Specialty features include:

  • Gasketed, sealed and washable ceilings

  • Full sheet glued Fiberglass Reinforced Polyester (FRP) or modular, seam sealed walls

  • Point of passage, magnehelic gauges for continuous monitoring of cleanroom zone pressures

  • Fully adjustable High Efficiency Particulate Air (HEPA) filter air handling system

  • Validated Ethylene oxide sterilization of supplies and equipment

  • Validated steam sterilization of supplies and equipment

Allograft Products

Sterile Demineralized Cortical Bone

  • 100% human cortical bone

  • Interwoven demineralized bone fibers provide a unique scaffold for bone formation

  • Shape conforming- excellent bone-graft contact for orthopedic applications and void filling

  • High Surface Area (HSA) –over 15 times* the surface area of cancellous bone for optimized cell adsorbption, retention and viability

  • Osteoconductive and Osteoinductive

  • Hydrates quickly and uniformly

  • Won’t wash away with irrigation/lavage- minimal graft migration

  • Sterilized to SAL 10-6 through gamma irradiation

  • No anatomical restrictions to the size or shape of the implants

Sterile Demineralized Bone Matrix

  • Made from 100% demineralized human bone – nothing added that may get in the way of bone healing

  • Osteoconductive – DBM provides an ideal scaffold that directs and supports bone formation

  • Osteoinductive – the osteoinductive potential of DBM is well established

  • Excellent handling characteristics – will shape and conform to fill unique bony voids – retains shape and will not wash away or migrate with lavage

  • Easy storage and use – stores at ambient room temperature and ready for immediate use; no prep time or reconstitution required

  • Sterile – gamma irradiated to SAL 10(-6)

  • Donor recovery and screening performed according to FDA guidelines
    Available in flowable, formable putty and crunch

  • SteriFuse Crunch™ consists of SteriFuse™ DBM putty with cortical cancellous bone chips

Sterile Precision Specialty Allografts

  • SteriSorb™ Osteoconductive Sponge Allografts - Made from 100% human cortical bone with wicking characteristics, and maintains the biocompatibility of human bone. SteriSorb™ Allografts compress to half of their original size (or less) then expands back to its original size to secure a better fit. SteriSorb™ allografts are sterilized with the GraftShield™ process for improved allograft safety. 

  • SteriGraft® Spacers - Computer designed and cut for high precision, tollerances and consistency. Designed to work with universal inserts. Unique groove surface serration pattern for improved traction. 

    • Cervical Fusion Spacer

    • ACF Cortical-Cancellous Spacer

    • Posterior Lumbar Interbody Fusion Spacer

    • Anterior Lumbar Interbody Fusion Spacer

  • SteriGraft® Dense Cancellous Block Allograft

  • SteriGraft® Unicortical Dense Cancellous Block Allograft

  • SteriFlex® Wrappable Bone Allograft

SteriGraft® Sterile Soft Tissue Allografts

  • Hemi / Whole Patellar Tendon

  • Pre-Shaped Patellar Tendon

  • Achilles Tendon - with or without Bone Block

  • Pre-Shaped Achilles Tendon

  • Gracilis Tendon 

  • Semitendinosus Tendon

  • Semitendinosus - Gracilis Bundle

  • Tibialis Tendon Anterior

  • Tibialis Tendon Posterior

  • Peroneus Longus Tendon

  • Plantaris Tendon

  • Fascia Lata

  • Pericardium 

SteriGraft® Sterile Traditional Bone Allografts

  • Cancellous Crushed 1-4mm

  • Cancellous Crushed 4-10mm

  • Cortical - Cancellous Crushed 1-4mm

  • Cortical Cancellous Crushed 4-10mm

  • Ilium Tricortical Block

  • Cortical - Cancellous Strut

  • Patella Block

  • Cortical Plate

  • Fibula Shaft

  • Femoral Head

Synthetics

  • Description: Confirm™ is an osteostimulative and osteoconductive bioactive bone void filler available in two different forms–gel and crunch.

  • Ease of Use: Confirm™ does not require special handling procedures prior to use. Confirm™ implants must be combined with autogenous graft material and bone marrow aspirate (BMA) in the following product:autograft:BMA ratios: Gel 3:1:1 and Crunch 10:2:1.

  • Storage: Confirm™ Bioactive is temperature sensitive and must be stored at room temperature (15°C-30°C; 59°F-86°F) in a clean, dry place. This product is stable at room temperature; no refrigeration or freezing is required.

Amniotic Specialty Products

  • Source: Human amniotic membrane

  • Description: Amnion is a versatile tissue with application in a variety of surgical procedures. Literature has documented amnion contains collagen, has a variety of growth factors, is biocompatible, and resorbs within the body. SteriShield® Protective Amnion Patch is an easy to handle, dry graft that rehydrates within the wound setting. Dual layer removes need for “sidedness” orientation or placement in the application site.

  • Common Surgical Applications: A wide variety of procedures can benefit from the SteriShield II™ Dual Layer Protective Amnion Patch.

  • Amnios™ Cryopreserved Liquid Amnion: a cyropreserved allograft derived from human amniotic fluid.

  • Amnios™ RT Acellular Liquid Amnion: a flowable tissue allograft derived from human amniotic fluid.

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CytoVive®

Transcending The Standard of Care

1-866-CYTOVIVE (298-6848)

(407) 353-4117