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Instructions for Use
Features & Benefits
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chronOS® Bone Graft Substitute contains calcium and phosphorus, two of the main mineral constituents of bone.
REMODELING WITHIN 6 TO 18 MONTHS1, 2, 3
Osteoclasts resorb chronOS Bone Void Filler implants like natural bone.1
chronOS® Bone Graft Substitute
- Available as granules and preformed shapes
- ChronOS Bone Void Filler implants benefit from a compromise between porosity and mechanical stability4,5
- The size of the macropores of chronOS Bone Void Filler implants are distributed within a range of 100 to 500 μm which provides the scaffold for vascularization and migration of osteoclasts and osteoblasts.6
- Can be perfused with the patient’s own blood or bone marrow
- Can be used alone or mixed with autograft for large volume defects
- Due to the synthetic origin of chronOS bone void filler implants there is no risk of animal tissue prion related disease transmission to the patient due to chronOS.7, 8, 9
References
1Buser D et al. (1998) Evaluation of filling materials in H2membrane protected bone defects: A comparative histomorphometric study in the mandible of miniature pigs. ClinOral Implants Res 9 (3): 137; 144-145
2Waisbrod H, Gerbershagen HU. A pilot study of the value of ceramics for bone replacement. Arch Orthop Trauma Surg. 1986;105(5):298-300
3van Hemert WL, Willems K, Anderson PG, van Heerwaarden RJ, Wymenga AB. Tricalcium phosphate granules or rigid wedge preforms in open wedge high tibial osteotomy: a radiological study with a new evaluation system. Knee. 2004;11(6): 451, 454-455
4Gazdag, A.R., Lane, J.M., Glaser, D., and Forster, R.A. (1995). Alternatives to autogenous bone graft: efficacy and indications. J Am Acad Orthop Surg 3: 4-5
5Chapter 5-Design Dossier-SE_634299_AA 5.2.3 Physico-Chemical Testing/Page 25
6Lu JX, Flautre B et al. (1999) Role of interconnections in porous bioceramics on bone recolonization in vitro and vivo. J Mater Sci Mater Med 10:111;113-120
7Stoll et al. (2004) New Aspects in Osteoinduction. Mat.-wiss. u. Werkstofftech, 35 (4), pp 198
8Kim, Y., Nowzari, H., Rich, S.K. Risk of Prion Disease Transmission through Bovine-Derived Bone Substitutes: A Systematic Review. Clinical Implant Dentistry and Related Research, Volume 15, Number 5, 2013. Pg 645-651
9Kim, Y., Nowzari, H., Rich, S.K. The Risk of Prion Infection through Bovine Grafting Materials. Clinical Implant Dentistry and Related Research, Volume 18, Number 6, 2016. Pg 1095-1100
Indication Statement
Oral/Maxillofacial:
Intended to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filling of cystic defects; filling of extraction sites; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors, cysts or other osseous defects; and substitute for autogenous or allogenic bone grafts. Intended to be gently packed or placed into the site and may be combined with autogenous blood or bone marrow, or saline. chronOS resorbs and is replaced with bone during the healing process.
Craniofacial:
Intended for the repair or filling of craniofacial defects and craniotomy cuts with a surface area no larger than 25 cm2.
Indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including fronto-orbital, malar and mental areas.
Intended to be gently packed or placed into the site.
chronOS Bone Graft Substitute resorbs and is replaced with bone during the healing process.
114884-190522 DSUS
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