Cleared Traditional

INTERGRO DBM (K082793) - FDA 510(k) Clearance

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

K082793 · Biomet Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
191d
Days
Class 2
Risk

K082793 is an FDA 510(k) clearance for the INTERGRO DBM. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biomet Spine (Irvine, US). The FDA issued a Cleared decision on April 2, 2009 after a review of 191 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Spine devices

Submission Details

510(k) Number K082793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2008
Decision Date April 02, 2009
Days to Decision 191 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 122d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K082793.
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 2013
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
K121989 · Exactech, Inc. · Nov 2012
WMT COMPOSITE DBM
K083270 · Wrightmedicaltechnologyinc · Aug 2009
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · Baxter Healthcare Corp · Oct 2008
POLYGRAFT BGS
K062607 · Smith & Nephew, Inc. · Nov 2007
SYNTHES CHRONOS COMPOSITE
K071046 · Synthes (Usa) · Oct 2007