Vivorte BVF Lite
FDA 510(k)Class II (US FDA 510(k))
by Vivorte, Inc
Identifiers
- 510(k) Number
- K131133 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vivorte BVF Lite is a resorbable calcium phosphate bone void filler classified under product code MQV as an orthopedic device. It is designed as a moldable, self-setting paste intended to fill non-structural bony voids or defects in extremities or the pelvis. The material is formulated to isothermally harden in vivo into carbonated apatite (hydroxyapatite), providing structural support during bone regeneration.
Intraoperatively, the device components are mixed to form a paste, which can be applied manually or via a cannula to the defect site. Supplied as a sterile, single-use system, it requires no external curing and is intended for one-time use per package. The device is regulated under FDA 510(k) clearance (K131133) and falls under the Traditional review pathway, classified as substantially equivalent to the predicate device.
Frequently asked questions
What is the Vivorte BVF Lite used for?
The Vivorte BVF Lite is designed to fill non-structural bony voids or defects in extremities or the pelvis. It provides temporary structural support during bone regeneration by hardening into carbonated apatite (a form of hydroxyapatite) after being applied as a moldable paste at the defect site.
How is the Vivorte BVF Lite supplied and prepared?
The Vivorte BVF Lite is supplied as a sterile, single-use system. Intraoperatively, the components are mixed to form a paste, which can be applied manually or via a cannula to the defect site. No external curing is required, as the material hardens isothermally in vivo.
Is the Vivorte BVF Lite reusable or single-use?
The Vivorte BVF Lite is intended for one-time use per package. Each sterile system is designed for a single surgical application to ensure safety and sterility, preventing cross-contamination or degradation of material properties.
What regulatory pathway does the Vivorte BVF Lite follow?
The Vivorte BVF Lite is regulated under the FDA’s Traditional review pathway and has received 510(k) clearance (K131133). It is classified as substantially equivalent to a predicate device and falls under product code MQV for orthopedic bone void fillers.
How does the Vivorte BVF Lite differ from other bone void fillers?
Unlike some bone void fillers that require external curing or are non-resorbable, the Vivorte BVF Lite is a resorbable calcium phosphate paste that hardens naturally in the body into carbonated apatite. Its self-setting, moldable consistency and single-use sterile packaging are key distinguishing features for filling non-structural defects.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K131133 FDA 510 (k) - VIVORTE BVF LITE | Vivorte, Inc., VIVORTE BVF LITE (K131133) — FDA 510 (k) | Innolitics, VIVORTE BVF LITE 510 (k) K131133 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131133 | Class II | Active |
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Manufacturer
- Manufacturer
- Vivorte, Inc
- FDA Applicant
- Vivorte, Inc.
Sources (1)
- FDA 510(k) K131133 24 fields · synced Oct 1, 2026