Cleared Traditional

K031838 - PROFUSION BONE VOID FILLER KIT

K031838 is an FDA 510(k) clearance for PROFUSION BONE VOID FILLER KIT, manufactured by Biogeneration. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K031838 · Biogeneration · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
136d
Days
Class 2
Risk

K031838 is an FDA 510(k) clearance for the PROFUSION BONE VOID FILLER KIT. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biogeneration (Lakeland, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 136 days - within the typical 510(k) review window.

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 Biogeneration devices

FDA 510(k) Submission Details - K031838

510(k) Number K031838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date October 30, 2003
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 352
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K031838.
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · Etex Corp. · Dec 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · Biomet Orthopedics, Inc. · Nov 2003
VITOSS-FILLED CARTRIDGE
K032130 · Orthovita, Inc. · Nov 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409 · Orthovita, Inc. · Aug 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · Wrightmedicaltechnologyinc · Jul 2003
MASTERGRAFT MATRIX
K023553 · Medtronic Sofamor Danek, Inc. · Apr 2003