Bone Graft

Cross sectional structure of bone sponge

İnternational Graft

İnternational Graft

THE SCIENCE OF NOVABONE NovaBone has been the subject of more than thirty basic science, in vivo, and human studies. It has been favorably compared to multiple alternative materials on the market today. NovaBone has a 15 – year track record of safety and efficacy in a wide range of clinical applications. Additionally, NovaBone has demonstrated equivalent rates of bone growth when compared to autogenous bone graft References 1. Oonishi H, Kushitani S, Yasakawa E, et al. Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clin Orthop. 1997;334:316-325. 2. Wheeler DL, Stokes KE, Hoellrich RG, Chamberland DL, McLoughlin SW. Effect of Bioactive Glass Particle Size on Osseous Regeneration of Cancellous Defects. J Biomed Mater Res. 1998;41:527-533 3. Brice Ilharreborde, MD, Etienne Morel, MD, Franck Fitoussi, MD, Ana presedo,MD, Philippe Souched, MD, Georges-Francois Pennecot, MD, and Keyvan Medza, MD. Bioactive Glass as a Bone Substitute For Spinal Fusion in Adolescent İdiopathic Scoliosis. J Pediatr Orthop. 2008;28:347-351. 4. Larry L. Hench, Julia M. Polak . A Genetic Basis for Design of Biomaterials for In Situ Tissue Regeneration. Key Engineering Materals 2008;337:151-166 5. Larry L. Hench, David M. Gaisser, The Genetic Basis for Osteogenesis Stimulation by Controlled Release of lonic Dissolution Products. Transactions of the Orthopedic Research Society, Annual Meeting, San Francisco, California, USA. March 2008:1697

İnternational Graft

The AlloGraft Leader

International Flexible Bone Graft

DBM Flexible Greft

BellaFuse™ yüksek miktarda allogreft kemik içeren (%50den fazla) elastik bir DBM türüdür ve insan jelatini ile karıştırılmıştır bu nedenle kemik rejenerasyonu için mükemmel yeterliliktedir. Ayrıca rehidrasyon yapılmadan kullanılabilir kemikli defekt bölgesine göre şekillendirilebilir ya da kesilebilir. Endikasyonlar :   

Ridge ogmentasyonu işlemlerinde onlay greftleme ile ridge genişliği oluşturması Kemik parçaları arasındaki küçük aralıkların birleştirilmesi Kemik oluşumu gereken defektlerin üzerinin kapatılması veya içlerinin doldurulması



Alveol rekonstrüksiyonuda kemikler veya kemik uzantılarının arasındaki boşlukların köprülenerek birleştirilmesi Human Laminaktomi Product Cat.No. DBM Cortical Size Gelatin cerrahisinde uygun BellaFuse DBF25 %50 %0 %50 25X25X2.5(mm) uygulama özelliği DBM Flex



BİRKAÇ DAKİKA Na+ ve H+ iyon Değişimi

BellaFuse DBM Flex

DBF50

%50

%0

%50

25X50X2.5(mm)

BellaFuse DBM Flex

DBF100

%50

%0

%50

25X100X2.5(mm)

BellaFuse Cortical Flex

CBF25

%0

%50

%50

25X25X2.5(mm)

BellaFuse Cortical Flex

CBF50

%0

%50

%50

25X50X2.5(mm)

BellaFuse Cortical Flex

CBF100

%0

%50

%50

25X100X2.5(mm)

BellaFuse Cortical Flex

CDF25

%15

%35

%50

25X25X2.5(mm)

BellaFuse Cortical Flex

CDF50

%15

%35

%50

25X50X2.5(mm)

BellaFuse Cortical Flex

CDF100

%15

%35

%50

25X100X2.5(mm)

6 SAAT Amorf kalsiyum fosfatın çökmesi

1 SAAT Na+ kaybı, çözünebilen Silisyum dioksit (silika) Salınmasını başlatır. Yüzeyde silanol (Si-OH) Gruplatı oluşur. Bunlar polimerize Olarak zengin silikalı tabakaya dönüşür.

20 SAAT 50 SAAT Biyolojik Kök hücrelerinin bileşiklerin absorbsiyonu fiksasyonu 10 SAAT 24 SAAT 100 SAAT Hidroksil karbonat Makrofajların Differentiation apatit tabakasının faaliyeti of the stem cells kristallesşmesi 1-10 gün büyümesi

0499

FLEX GRAFT AntartikTM Sponge

AntartikTM Sponge: Matrice ostéoconductrice, hémostatique et résorbable pour le comblement osseux Caracteristiques • • •

AntartikTM Sponge est un substitut osseux composé d’hydroxyapatite et de phosphate de tricalcium dispersés dans une matrice de collagène de type I et III. Repousse osseuse en 3 à 4 mois Propriétés hémostatiques validées (testé par un laboratoire externe)

Composition: 10% Collagen

AntartikTM Sponge

60% HAP

90% HAP/TCP 40 % TCP Antartik™ Sponge est utilisée pour le comblement de divers types de défauts osseux, aussi bien pour des raisons chirurgicales, traumatiques ou pathologiques. Elle est indiquée lors de : • prélèvement osseux (compact ou spongieux, greffe de tendon,…) • résection d’une tumeur osseuse; • ostéosynthèse; • arthrodèse, spondylodèse; • pseudarthrose; • ostéotomie (sternotomie,…); • autres défauts osseux. Pour les chirurgies maxillofaciale et dentaire, Antartik™ Sponge est indiquée en cas de reconstruction osseuse.

Substitut osseux

Matrice de collagène

Matrice de collagène

Substitut osseux

La matrice de collagène avec une dispersion homogène du substitut osseux : propriétés hémostatiques, colonisation des cellules et ostéoconduction.

Contact entre les granulés de susbstitut osseux et la matrice de collagène

T=0

Antartik™ Sponge : Matrice poreuse avec des granulés de substitut osseux (HAP+TCP)

T + 1 mois

Résorption totale du collagène Absence de signe d’inflammation ou de nécrose Début de la régénération osseuse

KOMED MEDİKAL SAĞLIK TİC. SAN. LTD. ŞTİ.

T + 3 mois

Atatürk Üniversitesi Ata Teknokent Binası B Blok No.: 74 / 122 Turkey - ERZURUM Telf : +90 234 20 50 - Faks : +90 234 40 10

Formation du nouvel os Début de la repousse osseux

Tailles KOMED MEDİKAL SAĞLIK TİC. LTD. ŞTİ. AntartikTM Sponge est présenté dans un double conditionnement et strérilisé par irradiation.

AntartikTM Sponge Tailles

Granulométrie du substitut osseux

Références

12x12x12mm

80 - 200 µm

SP-1XS01HT1

12x12x12mm

0,5 - 1 mm

SP-1XS01HT2

12x12x24mm

80 - 200 µm

SP-1S01HT1

12x12x24mm

0,5 - 1 mm

SP-1S01HT2

30x30x6mm

80 - 200 µm

SP-1M01HT1

30x30x6mm

0,5 - 1 mm

SP-1M01HT2

35x60x6 mm

80 - 200 µm

SP-1L01HT1

35x60x6 mm

0,5 - 1 mm

SP-1L01HT2

70x110x6 mm

80 - 200 µm

SP-1XL01HT1

70x110x6 mm

0,5-1 mm

SP-1XL01HT2

MedicalBiomat 5 chemin du catupolan 69120 vaulx en velin- France Tel:+33(0)4 72 81 22 62- Fax: +33(0)4 72 81 22 72

GENTA SENTETİK BONE GREFT

[G-FillinBone]

Substituts osseux synthétiques avec gentamicine Bone substitute with gentamicin La combinaison du comblement osseux et de l'antibioprophylaxie locale G-FILLINBONE est un substitut osseux synthétique biphasé (70% HAP et 30% ß-TCP) avec antibiotique. Il permet le comblement de cavités osseuses lors d'opérations chirurgicales orthopédiques (hors chirurgie contaminée), notamment dans les cas de : • pose de prothèse articulaire, • rachis, • traumatologie sur fracture fermée, • ostéotomies, • comblement après résection d'une tumeur. Il est particulièrement indiqué lorsque des germes sensibles à la gentamicine constituent un risque possible. Les substituts osseux G-FILLINBONE ont une porosité et une surface optimisée pour permettre une repousse osseuse rapide et une bonne ostéointégration. La structure de notre substitut osseux combine à la fois des macroporosités dont la totale interconnection favorise la pénétration des cellules, et des microporosités qui augmentent la surface de contact avec les fluides biologiques. La gamme G-FILLINBONE se décline en granulés permettant de combler des cavités de forme complexe, et en blocs qui pourront être façonnés aisément par le chirurgien suivant

Combining bone filling and local antibioprophylaxis G-FILLINBONE is a bi-phased synthetic bone substitute (70% Hydroxyapatite and 30% ß-TCP) with antibiotic. It has been specially designed in order to fill in bone cavities for orthopaedic surgical operations (except contaminated surgery), in particular in cases of: • joint prosthesis, • spinal, • traumatology on closed fracture, • osteotomies, • filling after tumour ablation. It is particularly indicated when germs sensitive to gentamicin constitute a possible risk. G-FILLINBONE Bone substitutes have an optimised porosity and surface to allow a rapid bone ingrowth and a good osteointegration. The structure of our bone substitute combines at the same time macroporosities whose total interconnection favours the penetration of the cells, and microporosities which increase the surface in contact with the biological fluids. The G-FILLINBONE range includes granules designed to fill in cavities of complex form, and blocks that can be cut easily by the surgeon in order to adapt to any particular indication.et de garantir ainsi une totale sécurité.

[ Caractéristiques ] Les substituts osseux GFILLINBONE ont une porosité et une surface optimisées pour permettre une repousse osseuse rapide et une bonne ostéointégration. La structure de G-FILLINBONE combine à la fois des macroporosités dont la totale interconnection favorise la pénétration des cellules et des microporosités qui augmentent la surface de contact avec les fluides biologiques. Les caractéristiques mécaniques de l'implant permettent de répondre à la plupart des indications cliniques. Les tests in vitro, les implantations animales ainsi que les résultats cliniques, démontrent une parfaite ostéointégration des substituts FILLINBONE.

FILLINBONE bone substitutes have optimised porosity and surface in order to induce fast bone ingrowth and good osteointegration. FILLINBONE's structure combines two different porosities. Thanks to their total interconnection, macroporosities favour the cells penetration, and the microporosities increase the surface in contact with the biological fluids. The mechanical characteristics of the implants make them appropriate for most clinical indications. In vitro tests, animal implantation and clinical results show a perfect osteointegration of FILLINBONE bone substitutes.

Fig.a : Implantation chez le lapin (3 mois Ulna) b Coupe histologique 100 µm observée en microradiographie Blanc : biomatériau Gris : tissu osseux minéralisé Noir : substances non minéralisées La minéralisation du tissu osseux qui pénètre dans les porosités est équivalente à celle du tissu osseux qui environne l'implant. Fig.a: Implantation on rabbit (3 month - Ulna) 100 µm histological section observed in microradiography. White: biomaterial Grey: mineralised bone tissue Black: non mineralised substances The mineralisation of bone tissue penetrating inside the porosities is equivalent to the mineralisation of the bone tissue surrounding the implant.

Fig.b : Implantation chez le lapin (3 mois - Ulna) Coupe histologique 50 µm coloré au MayGrünwald-Giemsa Noir : biomatériau Beige : tissu osseux minéralisé Bleu : cellules et tissu non minéralisés Pénétration du tissu minéralisé dans les porosités du biomatériau et début de biodégradation du biomatériau. Fig.b: Implantation on rabbit (3 mois - Ulna) 50 µm histological section coloured with MayGrünwald-Giemsa Black: biomaterial Beige: mineralised bone tissue Blue: non mineralised cells and tissue Penetration of mineralised tissue inside the porosities of the biomaterial and beginning of the biodegradation of the biomaterial.

GENTA SENTETİK BONE GREFT [ Présentation ] Conditionnement en double emballage stérile •A conserver à une température comprise entre 10° C et 40° C • Produit à usage unique, ne pas restériliser • Date de péremption : date de fabrication + 5 ans • Précautions d'emploi et contre-indications, se reporter à la noticedu fabricant.

Packed in double sterile packaging •The substitutes shall be stored at a temperature between 10° C and 40° C. • FILLINBONE is a single use product, it shall not be resterilised. •Expiry date: manufacturing date + 5 years •Precautions and contraindications: please refer to the instructions of the manufacturer.

ANTİBİYOTİKLİ KEMİK ÇİMENTOSU

GENTA FIX 1&3 ®

www.komedmedikal.com

www.komedmedikal.com

ANTİBİYOTİKLİ AKRİLİK KEMİK ÇİMENTOSU GENTA FIX® 1 ve 3 steril radyopak ve kendi kendine sertleşebilen çimento • Aminosit antibiyotik olan Gentamisin içerir. • Her ikiside artroplasti ameliyatları içindir. • İmplantların kemiğe hızlıca ve stabil şekilde tutunmasını sağlar

İki ayrı viskozitedeki ürün tipi cerrahın ihtiyaçları içindir.

www.komedmedikal.com

GENTA FIX® 1: Manuel uygulama için standart viskozite kemik çimentosu GENTA FIX® 3: Şırınga veya enjeksiyon tabancası ile uygulama için ideal akışkanlıktaki düşük viskoziteli kemik çimentosu.

ktttttt---------------------hhhhhhhhhhhhhhhhhhkkkkkkkkkkkkkkkkkkk Türkiye’nin Yetkili Disbiritoru

GENTA FIX 1 & 3 ®

Yeni jenerasyon kemik çimentosu avantajları • ISO 5833 Standartında mekanik özellikler

GENTA FIX® kemik çimentosu bölgesel antibiyotik terapisi yapar.

• Düşük ısı salınımı • Diğer çimentolardan düşük monomer salınımı

Gentamisin aminosit grubundandır, geniş etkili ve tekrarlayan enfeksiyonlar için verilir. Bir dozdaki gentamisin miktarı uzun süre salınımı garantiye almak ve enfeksiyonları önlemek için optimize edilmiştir.

• İmplant fiksasyonunda stabillik • Radyopak etken için baryum sülfat • Vakumlu veya spatula ile hazırlamada kolay uygulama

ISO 5833 standartında mekanik özellikler: Eğilme Modülü (Mpa) 4000

70

2000 1500 1000

0

500 0

60

1,0

50

0,8

40 30 20 10

GENTA FIX® 3

GENTA FIX® 1

20

2500

ISO 5833

ISO 5833

40

GENTA FIX® 3

60

GENTA FIX® 1

80

GENTA FIX® 3

3000

GENTA FIX® 1

3500

100

Vücut içi salınım hareketi (Baz mg)

Bükülme Direnci (MPa)

ISO 5833

Basınç dayanımı (Mpa) 120

0,6

GENTA FIX® 3 GENTA FIX® 1

0,4 0,2 0,0 0

18

36

0

54

72

Isı

90

108

126

144

162

Endikasyonlar Enfekte protezlerin revizyonları, implant fiksasyonları, kemik enfeksiyonu yüksek hastalar.

Saklama ve Ürünler

PAKET İÇERİĞİ

ÜRÜN KODU

GENTA FIX ® 1 - 40 gr toz ve 14,4 gr sıvı GENTA FIX ® 3 - 40 gr toz ve 16,4 gr sıvı Kase ve spatula 10 lu steril olmayan paket Kase ve spatula tekli steril paket Uzun borulu şırınga – steril olmayan tekli paket Kısa borulu şırınga – steril olmayan tekli paket

T040140G T040340G T060404 T060403 T060405 T060402

Yetkili Satıcı

snch

C er

13485

E N IS O 9

SO

- EN I 00 1

tifi e d

Classe III

www.komedmedikal.com Head offices: 8, rue du Corps Franc-Pommiès 65500 VIC en BIGORRE (France) Tél (33) 5 62 96 88 38 Fax (33) 5 62 96 28 72

Administration and supply-chain offices: Z.I de la Herray 65500 VIC en BIGORRE (France) Tél (33) 5 62 96 88 38 Fax (33) 5 62 96 28 72

Sales and engineering departments: Z.I. de Montredon - 11, rue Apollo 31240 L'UNION (France) Tél (33) 5 34 25 10 60 Fax (33) 5 34 25 27 39

PAKETLEME Sıvı: Cam ampul Toz: İkili poşet

Création Crédits photos : © Teknimed • Alexander Raths, astoria, olly, auremar - TF4310403/Ind0 - 09/2012

Çimentolar steril kullanıma hazır durumda ameliyathaneye teslim edilir. En fazla 25°C de temiz, karanlık ve kuru bir yerde açılmadan orjinal paketinde saklanır. Diğer bilgiler için lütfen IFU prosedürlerine bakınız.

EXABONE

®

PASTE

Bone Graft Substitute BIOMIMETIC | OSTEOSTIMULATIVE | EASY TO USE

Exabone GmbH is a Swiss based biotechnology leader that develops, manufactures and distributes innovative biomaterials across the globe. Capitalising on over 30 years experience in global markets our products are innovative, easy to use and proven the world over. EXABONE PASTE is an advanced pure synthetic nano biomaterial replicating the natural mineral phase of healthy human bone.

Advanced technology leads to unique specifications Optimised sticky viscosity allows a complete and easy filling of the defects, assuring a superior contact at the implant interface and will resist irrigation.

Optimised viscosity

The EXABONE PASTE nano surface area is 50 to 100 times greater than traditional synthetic bone graft.

BIOMIMETIC OSTEOSTIMULATIVE Highly moldable

EASY TO USE 100 m 2 /gram

Surface area

Nano engineered biomimetic material

2 m 2 /gram Traditional bone graft

EXABONE PASTE* * Dried measurement

Reliability & consistent performance The osteostimulative effects of the hydroxyapatite nano particles encourages osteogenesis. The ultra-high molecular surface area attracts and adsorbs the natural bone growth promoters available at the implant site.

Clinical applications Requires no mixing. Pre-loaded in convenient applicators ready for direct placement into the defect. The aqueous based composition is malleable and easily moulded by hand as needed.

EXABONE PASTE is designed for use in a broad range of non-load bearing osseous defects such as: spinal surgery (cage filling), osteotomies, bone cavity and defect filling, metaphyseal fractures, acetabulum reconstruction. EXABONE PASTE can be mixed with autologous or synthetic bone or bone marrow aspirate. The healing process starts by rapid colonization of the implant from the viable bone at the implant interface filling and replacing the nanostructure. The bone matures to woven bone and consolidates alongside cell mediated implant resorption.

Paste applicators

A full range ready to use Pre-loaded in convenient applicators ready for direct placement into the defect. EXABONE PASTE is gamma sterilized.

EXABONE® PASTE product range PASTE

08000005 0.5cc



08000010 1cc



08000020 2cc



08000025 2.5cc



08000050 5cc



09000050 10cc (multipack 2 x 5cc units)



10000050 15cc (multipack 3 x 5cc units)

Exabone GmbH, Route de Saint-Cergue 14 CH-1260 Nyon, Switzerland T +41-22 362 03 94 F +41-22 362 03 93 E [email protected] W www.exabone.com EXABONE is a registered trademark of Exabone GmbH. “The Swiss Bone Architect” and the logo are trademarks of Exabone GmbH. DOC01_0812_v1

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