(172 days)
BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.
BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. Bone bonding is a physico-chemical process leading to continuity between an implant and bone matrix. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%.
BonAlive™ products are supplied as granules are bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. BonAlive™ granules are sterilized in hot dry air. The granules are available as different granule and unit sizes.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. This 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device based on its composition, intended use, and device description, rather than presenting performance data against defined acceptance criteria.
The document is a 510(k) summary for BonAlive™ Granules, a bone grafting material. It describes the device, its intended use, and its equivalence to a predicate device (NovaBone Perioglas®, NovaBone-C/M®). The FDA letter confirms the substantial equivalence determination.
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§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.