Cleared Special

VITOSS-FILLED CARTRIDGE (K032130) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032130 · Orthovita, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
117d
Days
Class 2
Risk

K032130 is an FDA 510(k) clearance for the VITOSS-FILLED CARTRIDGE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on November 5, 2003 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthovita, Inc. devices

Submission Details

510(k) Number K032130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2003
Decision Date November 05, 2003
Days to Decision 117 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 183
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K032130.
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828 · Wrightmedicaltechnologyinc · Apr 2004
ALLOMATRIX MODEL# 86
K020895 · Wrightmedicaltechnologyinc · Mar 2004
EXACTECH RESORBABLE BONE PASTE
K020078 · Exactech, Inc. · Feb 2004
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · Wrightmedicaltechnologyinc · Jul 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336 · Wrightmedicaltechnologyinc · Mar 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · Biomet, Inc. · Feb 2003