sports medicine implants · 2013-02-01 · biocleanse® tissue sterilization process bone and...

Sports Medicine Implants

1Sports Medicine Implants

proven Q UA LI TY

Table of Contents

SterilizationProcessesOverview........................................3-4

WoundCoveringandAugmentation........................................5

Ligament Reconstruction....................................................6-8

Fresh-stored Osteochondral/Meniscus............................9-12

AboutRTIBiologics..........................................................13-14

Table of Contents 2

Afterconsent/authorizationfordonationisobtained,donorhistoryscreening and laboratory testing is performed in accordancewithFDAregulationsandAATBStandards.

Screening for Patient SafetyA complete donor risk assessment interview must be performed for every donor including:• Cause of death: Donors are only accepted if cause of death is

established.• DonorRiskAssessment:

RTI receives donated tissue from independently licensed recovery agencies which screen for safety prior to recovery, including conducting an interview with the family/next of kin and a behavioral/lifestyle risk assessment.

Following receipt of tissue from the recovery agency, RTI evaluates records from the recovery agency and performs the following donor risk assessment:

• Medicalrecord/hospitalrecordsreview • Medicalexaminer/coroner’sreport(autopsyreport,whenavailable) • Laboratory,pathologyandradiologyreports

ThefinaldeterminationofdonoreligibilityismadebyRTI’smedicaldirector–alicensedphysician–utilizingallavailable,relevantinformation.

Testing for Patient SafetyAn extensive panel of serological and microbiological tests are performed. These results are subject to stringent acceptance criteria in order to release the donor tissue.

Inadditiontoserologicaltestingonthedonor’sblood,microbiologicaltestingis used throughout the process (where appropriate) to screen for potentialcontamination and to provide confirmation of tissue suitability for transplant.

Through its innovations, RTI Biologics, Inc.

(RTI) continuously raises the bar of science and

safetyforbiologics–frombeingthefirstcompanyto

offerprecision-tooledboneimplantsandassembled

technology,toinventingfullyvalidatedsterilization

processesthatincludeviralinactivationsteps.Three

suchprocesses–theBioCleanse®TissueSterilization

Process,theTutoplast®TissueSterilizationProcess

and Cancelle® DBM Sterilization Process – have a

provencombined recordofmore than fourmillion

implantsdistributedwithzeroincidenceofimplant-

associated infection. Validation studies have been

performed for each process based on tissue type

usingappropriatechallengemicroorganisms.

•HCVAntibody

•HBVSurfaceAntigen

•HIV1&2Antibody

•HBVTotalCoreAntibody

•HTLV-I&HTLV-IIAntibody

•Syphilis

•HIV-I/NAT

•HCV/NAT

Serological Testing (for every donor):

The Path from Recovery to Implantation

BioCleanse® Tissue Sterilization Process

Tutoplast® Tissue Sterilization Process

Membranetissue,softtissueaugmentationgrafts,boneparticulate

DonorScreening

Serological&MicrobiologicalTesting

Tissuebeforeprocessing

Tissueshapedintofinalform

3Sterilization Processes Overview

BioCleanse® Tissue Sterilization Process

Boneandsportsmedicinesofttissue

Note: Fresh-stored osteochondral allografts are cleansed, processed and preserved to maintain chondrocyte viability, and therefore are not sterilized through one of these processes.

TissueundergoesTutoplastProcess

Tutoplast® Tissue Sterilization Process

SterilefinishedgraftValidated low dose gamma irradiation achieves terminal sterility of SAL 10-6.

TissuesterilizedtoSAL10-6

Bonegraftsareterminallysterilizedbyavalidated method. Sports medicine tendons are

not terminally irradiated.

Low-doseterminalirradiationg

Tutoplast® Tissue Sterilization ProcessTheTutoplastprocessisachemicalsterilizationmethodologyoriginallydeveloped40yearsagobyTutogenMedical,Inc.(nowmergedwithRTIBiologics,Inc.)tosterilizeandpreservetissueforimplantation. Membrane and soft tissue augmentation grafts, as well as bone particulate,sterilizedthroughTutoplastareusedindental,urological,wound covering and other procedures.

HowdoestheTutoplastprocesswork?Osmotic,oxidativeandalkaline(membranesonly)treatmentsbreakdown cell walls and inactivate or remove pathogens and bacteria. Solvent dehydration results in room temperature storage of tissue without damaging the collagen structure. Low dose gamma irradiation ensures sterility of final packaged product.

BioCleanse® Tissue Sterilization Process RTIBiologics’allograft constructs/spacersandsportsmedicinesofttissueimplantsaresterilizedtoSterilityAssuranceLevel10-6 through its patented BioCleanse Tissue Sterilization Process, an automated,pharmaceutical grade process. BioCleanse sterilization is used ongrafts that provide a natural biologic scaffold in orthopedic, spine and sports medicine procedures.

HowdoestheBioCleanseprocesswork?TheBioCleansesystemsterilizes tissue toSAL10-6 using a complex, proprietary combination of mechanical and chemical processes, working in conjunction with each other. The mechanical component applies oscillating positive and negative pressureinthepresenceofthechemicalagents(includingdetergentsandsterilants),whichgentlyperfusethetissue. Thiscombinationremoves blood and lipids, and inactivates or removes pathogenic microorganisms. Repeated water rinses throughout the process remove debris, and final water rinses remove residual chemicals, leaving the tissue biocompatible. The BioCleanse process does not sterilizeusingirradiation.

Evenifothersafeguardsfail,RTI’sBioCleansetechnologysterilizesboth bone and soft tissue to SAL 10-6. This SAL was established usingworstcasetestingscenarioswhichincludedAchillestendon(becauseof itsdensenature)andspores(becausetheyarethemostdifficultmicroorganismstoremove).

Lowtemperaturechemicalprocess

Tissueshapedintofinalform

Sterilization Processes Overview 4

RT=Room Temperature

Wound Covering and Augmentation

Matrix™ HD Graft

• Sterile room temperature human dermis graft

• Well-suited for reconstructive surgical applications and treatment of chronic skin wounds

Matrix™ HD Sterilization: Tutoplast®

Code Description Storage

TD2203 2cmX3cm RTTD0405 4cmX5cm RTTD0508 5cmX8cm RTTD0214 2cmX14cm RTTD1010 10cmX10cm RTTD1315 13cmx15cm RT

(Stored dehydrated at room temperature for off-the-shelf use)

5Wound Covering and Augmentation

Pre-shaped Bone-Patellar Tendon-Bone (BTB)

Pre-shaped Bone-Patellar Tendon-Bone (BTB) Sterilization: BioCleanse®


453002 Pre-shapedBTB10mm FZ453005 Pre-shapedBTB11mm FZ453012 Pre-shapedBTB9/10mm FZ453013 Pre-shapedBTB10/11mm FZ

BTB Select® Allograft

• Assembledtechnologyprovidesprecisionsize-matchingrelativeto the intra-articular length of BTB allografts

BTB Select® Allograft Sterilization: BioCleanse®


455034 BioCleanse® BTB Select®pre-shaped10/10mm FZ

RTI maintains an inventory of intra-articular lengths from 35-44mm.

Adjustable Length BTB

• Combines the flexibility of soft tissue grafts with BTB fixation

Adjustable Length BTB Sterilization: BioCleanse®


453028 Femoralboneblockwitheyelet FZ453029 Tendonwithassembledtibialboneblock FZ

Please Note: Order both the femoral bone block with eyelet and the tendon with assembled tibial bone block for a complete Adjustable Length BTB graft configuration.

FZ=Frozen

Ligament Reconstruction

Ligament Reconstruction 6

NON-IRRADIATED

NON-IRRADIATED

NON-IRRADIATED

Pre-shaped, Pre-trimmed and Conventional Achilles Tendons

Pre-shaped Achilles Tendons Sterilization: BioCleanse®


453006 Pre-shapedAchillesTendonwithCalcaneus10mm FZ453004 Pre-shapedAchillesTendonwithCalcaneus11mm FZ

Pre-trimmed Achilles Tendons Sterilization: BioCleanse®

453206 Pre-trimmedAchillesTendonwithCalcaneus FZ

Conventional Achilles Tendons Sterilization: BioCleanse®

453042 AchillesTendonwithLargeCalcaneus FZ

Hemi and Whole Patellar Tendons

Hemi and Whole Patellar Tendons Sterilization: BioCleanse®


453008 PatellarTendonHemi FZ453010 PatellarTendonWhole FZ

Pre-shapedAchilles

Pre-trimmedAchilles

HemiPatellarTendon

WholePatellarTendon

ConventionalAchilles

FZ=Frozen


7Ligament Reconstruction

NON-IRRADIATED

NON-IRRADIATED

Tibialis and Peroneus Tendons

Tibialis and Peroneus Tendons Sterilization: BioCleanse®


453016 PosteriorTibialisTendon FZ453017 AnteriorTibialisTendon FZ453043 PeroneusLongusTendon FZ

Peroneus

Tibialis

Semitendinosus

Gracilis

FZ=FrozenFD=Freeze Dried

Semitendinosus and Gracilis Tendons

Semitendinosus and Gracilis Tendons Sterilization: BioCleanse®


453015 Semitendinosus Tendon FZ453014 Gracilis Tendon FZ

Unicortical Bone Dowel

Unicortical Bone Dowel Sterilization: BioCleanse®

Code Description HxD Storage

D02808 UnicorticalDowel 8x30-35mm FDD02810 UnicorticalDowel 10x30-35mm FDD02812 UnicorticalDowel 12x15-35mm FDD02814 UnicorticalDowel 14x15-35mm FDD02816 UnicorticalDowel 16x15-35mm FDD02818 UnicorticalDowel 18x15-35mm FD


Ligament Reconstruction 8

H

D

UnicorticalDowel(Lumbar) 15-35mmDia.

NON-IRRADIATED

NON-IRRADIATED

Fresh-stored OC Talus*

• SpecificallysizedtomatchpatientradiographsorMRIs

Fresh-stored OC Talus Aseptically Processed


002680 Left Talus RF002681 Right Talus RF

*Fresh-stored osteochondral allografts are cleansed, processed and preserved to maintain chondrocyte viability, and therefore are not sterilized through the BioCleanse®, Tutoplast® or Cancelle® SP sterilization processes.

RF=Refrigerated

Fresh-stored Osteochondral

Fresh-stored OC Femoral Condyle*


Fresh-stored OC Femoral Condyle Aseptically Processed


002682 Left Lateral Condyle RF002683 Left Medial Condyle RF002684 Right Lateral Condyle RF002685 Right Medial Condyle RF

9Fresh-stored Osteochondral

Fresh-stored OC Humeral Head*


Fresh-stored OC Humeral Head Aseptically Processed


002672 Left Humeral Head RF

002673 Right Humeral Head RF


Fresh-stored Osteochondral 10

RF=Refrigerated

Fresh-stored OC Distal Tibia*


Fresh-stored OC Distal Tibia Aseptically Processed


002670 DistalTibiaOCLeft RF002671 DistalTibiaOCRight RF

*Fresh-stored osteochondral allografts are cleansed, processed and preserved to maintain chondrocyte viability, and therefore are not sterilized through the BioCleanse®, Tutoplast® or Cancelle® SP sterilization processes.


11Fresh-stored Osteochondral

Fresh-stored OC Patella*


Fresh-stored OC Patella® Aseptically Processed


002676 LeftPatella RF002677 RightPatella RF

Fresh-stored OC Trochlea*


Fresh-stored OC Trochlea Aseptically Processed


002674 Left Trochlea RF002675 Right Trochlea RF

RF=Refrigerated

FZ=Frozen

Meniscus

Meniscus 12

BioCleanse® Meniscus


BioCleanse® Meniscus Sterilization: BioCleanse®


453101 MeniscusLateralwithBoneBridge(Left) FZ453102 MeniscusLateralwithBoneBridge(Right) FZ453201 MeniscusMedialwithBoneBridge(Left) FZ453202 MeniscusMedialwithBoneBridge(Right) FZ453030 MeniscusLateralwithoutBoneBridge FZ

NON-IRRADIATED

• Strongcommitmenttoadvancingscience,safetyandinnovation

• Globalleaderintissue-basedinnovations

• Preciselyshapesallografttissueforuseinsurgeries

• Sterilizestissuewithproprietary,validatedsterilizationprocessesthatinactivateviruses—includingBioCleanse®TissueSterilizationProcess,Tutoplast®TissueSterilizationProcess,andCancelle®SPDBMSterilizationProcess

RTI Biologics, Inc. is the leading provider of sterile biological implants for surgeries around the world with a commitment to advancing science, safety and innovation. RTI prepares human donated tissue for transplantation through extensive testing andscreening,precisionshapingandproprietary,validatedsterilizationprocesses.

RTI’sinnovationscontinuouslyraisethebarofscienceandsafetyforbiologics—from being the first company to offer precision-tooled bone implants and assembled technology to maximize each gift of donation, to inventing fullyvalidated sterilization processes that include viral inactivation steps. Theseprocessessterilizetissue,areclinicallysuccessfulandarescientificallyprovento address donor-to-recipient disease transmission risk while preserving tissue strength and biocompatibility. They have a proven record of more than four millionimplantsdistributedwithzeroincidenceofimplant-associatedinfection.

RTI’s worldwide corporate headquarters are located in Alachua, Fla., withinternationalfacilitiesinNeunkirchen,Germany,andAix-en-Provence,France.Thecompany is accredited in the U.S. by the American Association of Tissue Banks.

About RTI Biologics, Inc.

13About RTI Biologics

proven Q UA LI TY

About RTI Biologics 14

Vision Wewillberecognizedastheworldleaderintransformingdonatedandnaturaltissueintosafe and innovative biologic solutions.

Mission

We improve lives by using the body to heal the body to achieve life-restoring results.

References1 Archibald,LA,etal.,“SeroprevalenceofBloodborneVirusesAmongCadavericDonorsofHumanTissue:

ImplicationsforTissueSafety.”PresentedatEATB2005.2 Carr, AS, et. al., “Mechanical Testing of Soft Tissue Allografts Sterilized Through the BioCleanse

Process.”Unpublisheddata,2005.

11621 Research Circle

Alachua, FL 32615

Toll Free: 877.343.6832

Fax: 386.418.0342

www.rtibiologics.com

To order, call RTI directly: 800.624.7238.

proven Q UA LI TY

•AccreditedbyAmericanAssociationofTissueBanks•ISO13485Certified•AdvaMedMember

BioCleanse® and Cancelle® are U.S. registered trademarks of RTI Biologics, Inc. Tutoplast® is a U.S. registered trademark of Tutogen Medical GmbH.

©2013 RTI Biologics, Inc. 3147 R7 02-01-13

sports medicine implants · 2013-02-01 · biocleanse® tissue sterilization process bone and...

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