Cleared Special

K083033 - VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE

K083033 is an FDA 510(k) clearance for VITOSS BONE GRAFT SUBSTITUTE, manufactured by Orthovita, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 27-day FDA review.

K083033 · Orthovita, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
27d
Days
Class 2
Risk

K083033 is an FDA 510(k) clearance for the VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & B.... 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 6, 2008 after a review of 27 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K083033

510(k) Number K083033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2008
Decision Date November 06, 2008
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

MQV Device Classification - Class 2, Special Controls

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 456
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K083033.
PROGENIX PLUS
K082002 · Medtronic Sofamor Danek · Nov 2008
GENEX
K082381 · Biocomposites, Ltd. · Nov 2008
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
K081979 · Apatech , Ltd. · Nov 2008
POLYBONE GRANULE & BLOCK
K082338 · Kyung Won Medical Co., Ltd. · Oct 2008
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
K082615 · Osteotech, Inc. · Oct 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · Baxter Healthcare Corp · Oct 2008