Bonalive Granules and Bonalive Plates
by Vivoxid, Ltd. EUDAMED510(k)
Active
510(k) K071937
Overview
Bonalive Granules and Bonalive Plates are synthetic bone graft materials designed for maxillofacial reconstruction. The granules consist of polytetrafluoroethylene (PTFE) and vitreous carbon, providing structural support and integration with natural bone tissue in surgical applications.
These devices are supplied as sterile, single-use materials intended for use in maxillofacial procedures under controlled surgical conditions. They are classified as Class II devices under FDA regulations (21 CFR 878.3500) and comply with the Medical Devices Directive (MDD). Multiple registration numbers (e.g., 1032347, 3014680740) correspond to distinct lot or batch identifiers for traceability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK071937 | Date19 Oct 2007 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KKY
- FDA applicant
- Vivoxid , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3500
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vivoxid, Ltd.
Questions
What types of maxillofacial procedures are these materials intended for, and how do they support bone integration?
Bonalive Granules and Bonalive Plates are synthetic bone graft materials designed specifically for maxillofacial reconstruction. The granules combine polytetrafluoroethylene (PTFE) and vitreous carbon to provide structural support and promote integration with natural bone tissue during surgical procedures. They are intended for use in controlled surgical environments where bone regeneration or stabilization is required, such as in facial trauma repairs, bone defect filling, or reconstructive surgeries.
Are Bonalive Granules and Bonalive Plates reusable, or are they meant for single-use only?
These materials are explicitly supplied as sterile and intended for single-use only. Since they are designed for surgical applications where contamination risks must be minimized, reuse is not recommended or supported by the manufacturer.
How are Bonalive Granules and Bonalive Plates packaged and stored, and what should be considered for traceability?
The materials are supplied in sterile packaging for surgical use. Each lot or batch is assigned distinct registration numbers (e.g., 1032347, 3014680740) to ensure traceability. Storage should follow manufacturer guidelines to maintain sterility, and the lot numbers should be documented for compliance and recall purposes if needed.
What regulatory pathways have these devices undergone, and which advisory committee was involved in their evaluation?
Bonalive Granules and Bonalive Plates were cleared through the FDA’s 510(k) process under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). The review was conducted by the Orthopedic and Rehabilitation Devices Advisory Committee (SU), reflecting their classification as Class II devices under 21 CFR 878.3500. They also comply with the Medical Devices Directive (MDD) in international markets.