(120 days)
OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.2~2.0 mm. It is supplied sterile by gamma irradiation.
The provided document describes the OSTEON II device, a synthetic bone grafting material. It outlines the device's characteristics, indications for use, and performance data for biocompatibility and bench testing. However, it does not include specific acceptance criteria or a study designed to demonstrate that the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (OSTEON) based on similar materials, indications for use, and design.
Here's an breakdown of the information that is available and what is missing based on your prompt:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO Cytotoxicity | Met standards |
| ISO Pyrogenicity | Met standards |
| ISO Intracutaneous reactivity | Met standards |
| ISO Ames | Met standards |
| ISO Systemic toxicity | Met standards |
| ISO Sensitization | Met standards |
| ISO Implantation | Met standards |
| ISO Micro-nucleus | Met standards |
| Performance Bench Testing: | |
| -Ca/P ratio | Met established specifications |
| -Crystalline Phase Compositions | Met established specifications |
| -Porosity | Met established specifications |
| -Water Solubility Test | Met established specifications |
| -Density | Met established specifications |
| -Crystallinity Value | Met established specifications |
Missing: The document does not provide numerical acceptance criteria for any of these tests (e.g., "Cytotoxicity score must be
§ 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.