Cleared Traditional

VITOMATRIX (K091618) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091618 · Orthovita, Inc. · Dental device
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Sep 2010
Decision
481d
Days
Class 2
Risk

K091618 is an FDA 510(k) clearance for the VITOMATRIX. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on September 27, 2010 after a review of 481 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Orthovita, Inc. devices

Submission Details

510(k) Number K091618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date September 27, 2010
Days to Decision 481 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
354d slower than avg
Panel avg: 127d · This submission: 481d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
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 Dental devices follow this clearance model.

Regulatory Peers - LYC Bone Grafting Material, Synthetic

All 17
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K091618.
OsOpia Synthetic Bone Void Filler
K201546 · Revisios BV · Oct 2020
Straumann BoneCeramic
K201051 · Institut Straumann AG · Sep 2020
Cytrans Granules
K192597 · GC America, Inc. · Aug 2020
TRICOS A RESORBABLE SUBSTITUTE
K081721 · Baxter Healthcare Corp · Aug 2008
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · Synthes (Usa) · Jan 2006
MIMIX BONE REPLACEMENT SYSTEM
K003494 · Biomet, Inc. · Apr 2001