Cleared Traditional

OSTEOCRETE BONE VOID FILLER (K071004) - FDA 510(k) Clearance

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

K071004 · Bone Solutions, Inc. · Orthopedic device
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May 2009
Decision
773d
Days
Class 2
Risk

K071004 is an FDA 510(k) clearance for the OSTEOCRETE BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Bone Solutions, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on May 21, 2009 after a review of 773 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Orthopedic submissions.

View all Bone Solutions, Inc. devices

Submission Details

510(k) Number K071004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2007
Decision Date May 21, 2009
Days to Decision 773 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
651d slower than avg
Panel avg: 122d · This submission: 773d
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 202
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K071004.
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392 · Globus Medical, Inc. · Dec 2010
WMT COMPOSITE DBM
K083270 · Wrightmedicaltechnologyinc · Aug 2009
MASTERGRAFT STRIP
K082166 · Medtronic Sofamor Danek · Jun 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008
PROGENIX PLUS
K082002 · Medtronic Sofamor Danek · Nov 2008