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Vitoss-Filled Cartridge

by Orthovita, Inc.

510(k) K032130

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK032130 Date5 Nov 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vitoss-Filled Cartridge is a piston syringe system designed for the aspiration of autogenous blood and/or bone marrow. It combines the Vitoss Scaffold Synthetic Cancellous Bone Void Filler and the Imbibe I1 Syringe into a kit configuration, providing surgeons with a convenient method to mix autologous blood or bone marrow with Vitoss Scaffold and deliver the material to orthopedic surgical sites.

This device is supplied as a single-use cartridge and is regulated as a Class 2 orthopedic device with product code MQV. It received FDA 510(k) clearance through the Special pathway on November 5, 2003, after a 117-day review. The device is intended for use in orthopedic surgical procedures and is not indicated for MRI environments.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Vitoss-Filled Cartridge used for?

    The Vitoss-Filled Cartridge is a piston syringe system designed for the aspiration of autogenous blood and/or bone marrow, which can then be mixed with Vitoss Scaffold Synthetic Cancellous Bone Void Filler and delivered to orthopedic surgical sites.

  • Is the Vitoss-Filled Cartridge single-use or reusable?

    The Vitoss-Filled Cartridge is supplied as a single-use cartridge and is regulated as a Class 2 orthopedic device with product code MQV, meaning it should be discarded after a single surgical procedure.

  • What regulatory approvals does the Vitoss-Filled Cartridge have?

    The Vitoss-Filled Cartridge received FDA 510(k) clearance through the Special pathway on November 5, 2003, after a 117-day review, and is regulated as a Class 2 orthopedic device with product code MQV.

  • Can the Vitoss-Filled Cartridge be used in MRI environments?

    No, the Vitoss-Filled Cartridge is not indicated for use in MRI environments, as specified in its device description and regulatory information.