Cleared Traditional

K071004 - OSTEOCRETE BONE VOID FILLER

K071004 is an FDA 510(k) clearance for OSTEOCRETE BONE VOID FILLER, manufactured by Bone Solutions, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 773-day FDA review.

K071004 · Bone Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K071004

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.

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 291
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K071004.
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