Cage fillers - bone graft

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Transcript of Cage fillers - bone graft

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Table of Contents :

Section 1 ELIZ Product 2

Description 2

Ordering Information 3

Section 2 OSIQ Product 4

Description 4

Ordering information 5

Section 3 ZETH Product 6

Description 6-7

Ordering information 7

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ELIZ is a sterile and reliable alternative for cancellous autograft or allograft. It is biocompatible and osteoconduc-tive. The composition of ELIZ (60% HA and 40% b-TCP) is similar to the mineral component of human bone andundergoes complete resorption at a controlled rate. Due to the similarity of the interconnected structure with humancancellous bone, ELIZ provides an ideal environment for the ingrowth of new bone.

The porosity of ELIZ is 83%. This ultra high porosity allows rapid bone ingrowth throughout the pores. ELIZ willprovide support without significantly limiting natural bone density. Microporosity (1.0 – 10um) within the HA/TCPstructure assists the transfer of essential nutrients.

ELIZ bone graft substitute

A safe and effective substitute for autograft

ELIZ is gamma sterilized and available is severalvolumes and sizes. Supported by more than 3000publications and over 500 clinical studies with respect tothe biocompatibility and clinical efficacy of HA and b-TCP as bone substitute material, 25 years of successful useis proven.

FEATURES

- Proven biocompatibility and osteoconductivity- Osteoblastic activity is encourages by osteoclastic resorp-tion and phagocytosis, releasing calcium and phosphate ions locally- For easy handling, ELIZ granules can be mixed withblood, bone marrow or platelet concentrate to form a cohe-sive mixture- ELIZ will integrate with new bon completely within 12 - 14weeks. The implant is than embedded within new bone form-ing bicontinuous matrix

Ordering Information

Type Volume Packaging Art. code EAN bar codeStrip 4 x 10 x 45 mm Box of 1 unit 4912311 8718026120xxx

4 x 10 x 45 mm Box of 3 units 4912310 87180261204745 x 12 x 50 mm Box of 1 unit 4912321 8718026120xxx5 x 12 x 50 mm Box of 3 units 4912320 8718026120481

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Type Volume Packaging Art. code EAN bar codeCylinder 5D x 5mm Box of 1 unit 4912110 8718026120214

5D x 10 mm Box of 1 unit 4912111 871802612022110D x 10 mm Box of 1 unit 4912121 871802612024510D x 15 mm Box of 1 unit 4912122 871802612025215D x 15 mm Box of 1 unit 4912132 871802612028315D x 20 mm Box of 1 unit 4912133 871802612029020D x 20 mm Box of 1 unit 4912143 8718026120337

Type Volume Packaging Art. code EAN bar codeBlock 5 x 10 x 10 mm Box of 1 unit 4912410 8718026120344

5 x 10 x 20 mm Box of 1 unit 4912412 871802612035110 x 10 x 10 mm Box of 1 unit 4912420 871802612038210 x 20 x 20 mm Box of 1 unit 4912460 871802612042910 x 20 x 40 mm Box of 1 unit 4912480 871802612044320 x 20 x 20 mm Box of 1 unit 4912492 8718026120467

Type Volume Packaging Art. code EAN bar codeGranules 0.8 - 1.5 mm 0.25 cc Box of 1 unit 4915002 8718026121747

0.5 cc Box of 1 unit 4915005 87180261217541.0 cc Box of 1 unit 4915010 87180261217611.5 cc Box of 1 unit 4915015 87180261217782.0 cc Box of 1 unit 4915020 87180261217852.5 cc Box of 1 unit 4915025 87180261201465.0 cc Box of 1 unit 4915050 871802612015310.0 cc Box of 1 unit 4915100 871802612016015.0 cc Box of 1 unit 4915150 871802612017720.0 cc Box of 1 unit 4915200 871802612018425.0 cc Box of 1 unit 4915250 871802612019130.0 cc Box of 1 unit 4915300 8718026120207

Type Volume Packaging Art. code EAN bar codeGranules 1.0 - 4.0 mm 2.5 cc Box of 1 unit 4911025 8718026120009

5.0 cc Box of 1 unit 4911050 871802612001610.0 cc Box of 1 unit 4911100 871802612002315.0 cc Box of 1 unit 4911150 871802612003020.0 cc Box of 1 unit 4911200 871802612004725.0 cc Box of 1 unit 4911250 871802612005430.0 cc Box of 1 unit 4911300 8718026120061

Type Volume Packaging Art. code EAN bar codeGranules 0.5 - 1.0 mm 0.25 cc Box of 1 unit 4914002 8718026121693

0.5 cc Box of 1 unit 4914005 87180261217091.0 cc Box of 1 unit 4914010 87180261217161.5 cc Box of 1 unit 4914015 87180261217232.0 cc Box of 1 unit 4914020 87180261217302.5 cc Box of 1 unit 4914025 87180261200785.0 cc Box of 1 unit 4914050 871802612008510.0 cc Box of 1 unit 4914100 871802612009215.0 cc Box of 1 unit 4914150 871802612010820.0 cc Box of 1 unit 4914200 871802612011525.0 cc Box of 1 unit 4914250 871802612012230.0 cc Box of 1 unit 4914300 8718026120139

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OSIQ is a ready-to-use nano bone graft substitute which is an injectable bone matrix paste.It is fully synthetic ultra pure nano hydroxyapatite which can be used for the filling or reconstruc-tion of small and medium bone defects. OSIQ can be combined with ELIZgranules, REOS strips, or autologous and allogenic cancellous bone likeZETH. OSIQ does not harden in contact with blood or spongiosa. OSIQ is non-load-bearing and is due to its nanocrystalline structure degradable. The unique viscosity of OSIQ will not harden, this will ensure a quick resorption by macrophages and osteoclasts.

SYNTHETIC bone substitute

Synthetic bone substitute of pure nano hydroxyapatite

FEATURES

- Innovative nano technology- Ready to use injectable- Fully synthetic- Biodegradable

INDICATIONS

- Osteotomies- Filling cages in spinal surgery- Defect filling - small / medium- Acetabulum reconstruction- Metaphysial fractures

BIOCOMPATIBILITY

During in vitro test to investigate the biocompatibility of OSIQ it was compared with another commercial aviail-able nano-paste. OSIQ showed evidence of in vitro biocompatibility and outperformed the commercial nano-paste already on the market.

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Type Volume Packing Art. code EAN bar codeSyringe 0.5 cc Box of 1 unit 4913105 8718026120498

0.5 cc Box of 2 units 4913205 87180261205351.0 cc Box of 1 unit 4913110 87180261205041.0 cc Box of 2 units 4913210 87180261205422.0 cc Box of 1 unit 4913120 87180261205112.0 cc Box of 2 units 4913220 87180261205593.0 cc Box of 1 unit 4913130 87180261218843.0 cc Box of 2 units 4913230 87180261218915.0 cc Box of 1 unit 4913150 87180261205285.0 cc Box of 2 units 4913250 8712026120566

Ordering Information

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DBM The putty version of the ZETH DBM (demineralized bone matrix) contains 80% demieralized human bone by volume and provides optimal characteristics for guided bone regeneration. The crush version of the ZETH DBM is a mix of 70% putty with 30% allograft cancellous crushed bone chips (1-6mm). This will allow a rigid and solid filling of the bone void. ZETH DBM is available in 1.0, 2.5, 5.0 and 10 cc. The DBM is also avail-able in flexible strips; these will become flexible after hydration, The DBM FLEX is available in three sizes; 15x15, 20x30 and 25x50mm.

Our safe standard enables rapid and reliable bone repair

ZETH DBM substitute

KYERON DBM is a ready-to-use injectable and may be used in a variety of orthopaedic, reconstructive, neurosurgical, and periodontal tissue grafting procedures. KYERON DBM is a powerful bone graft material which provides superior handling characteristics

BONE CHIPS The ZETH human tissue is also available in cancellous and cortical-cancellous bone chips of different granules sizes and convenient volumes. The smallest granules size is 0.5-2mm and the largest is 4-10mm and it is available from 1cc to 60 cc.

ZETH bone chips are completed under environmentally controlled conditions. All steps are rigorously quality con-trolled. ZETH bone chips may be used in a variety of orthopaedic, reconstructive, neurosurgical, and periodontal tissue grafting procedures.

The ZETH DBM products are processed by a four step production process by acidification of allograft bone chips. The whole production procedure will remove any cells and bacteria including DNA and RNA.This will ensure the ZETH DBM to be acellular, Our production is completed under environmentally controlled condi-tions. All steps are rigorously quality controlled.

KYERON and our tissue partners are accredited by the AATB and comply with the voluntary standards and guide-lines developed by AATB. The source of human tissue for the ZETH products is USA, from an AATB approved bone bank.

AATB ACCREDITATION

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Recovery of bone is conducted by highly trained procurement technicians in accordance with AATB standards. Technicians complete an examiniation to identify possible physical evidence of any high risk conditions and tissue recovery is performed within recommended time constraints. Aseptic techniques such as surgical skin prep and sterile instruments are utilised to ensure a high quality tissue.

A blood sample is collected from the donor and tested for infectious diseases by a CLIA-certified laboratory. Sero-logical testing includes:- Antibody to Human Immunodeficiency Virus 1 & 2 (anti HIV 1 & 2)- Hepatitis B Surface ANitgen (HBsAg)- Hepatitis B Core IgG/IgM Antibody (HBcAb)- Antibody to Hepatitis C (anti-HCV)- Antibody to Human T-Cell Lymphotropic Virus Type I & II (anti-HLTV Type I & II)- Rapid Plasma Reagin or Serologic Test for Syphilis (STS by RPR)- Human Immunodeficiency Virus DNA using polymerase chain reaction (HIV NAT) using Transcription Mediated Amplification (TMA)

Swab cultures for microbiological testing are obtained either at the time of recovery or prior to process-ing. Cultures are incubated in two types of media at two temperatures for a minimum of seven days. Any aerobic or anaerobic bacteria detected are identified to the genus level.Our freeze dried ZETH (DBM and ALLOGRAFTS) products are sterilised by gamma irradiation.

Ordering Information

Type Volume Packing Art. code EAN bar codeDBM Putty / Paste 1.0 cc Pouch of 1 unit 4961110 8718026120825(syringe) 2.5 cc Pouch of 1 units 4961120 8718026120832

5.0 cc Pouch of 1 unit 4961130 871802612084910.0 cc Pouch of 1 units 4961140 8718026120856

In accordance with AATB and FDA requirements, KYERON and its recovery partners utilise extensive evaluation criteria to identify and exclude high risk donors. To ensure the safety of each allograft produced, all recovered tissue is first quarantined until donor eligibility has been established Donor eligibility is assessed using a compre-hensive screening process that includes a complete medical and social history, physical examination, serological evaluation and microbiological testing.

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