Cleared Traditional

K073341 - GENEX PUTTY

K073341 is an FDA 510(k) clearance for GENEX PUTTY, manufactured by Biocomposites, Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K073341 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
224d
Days
Class 2
Risk

K073341 is an FDA 510(k) clearance for the GENEX PUTTY. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on July 9, 2008 after a review of 224 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 Biocomposites, Ltd. devices

FDA 510(k) Submission Details - K073341

510(k) Number K073341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2007
Decision Date July 09, 2008
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 122d · This submission: 224d
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 262
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K073341.
MODIFICATION TO MICROFUSE BONE VOID FILLER
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K081758 · Depuy Spine, Inc. · Sep 2008
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
K081558 · Pioneer Surgical Technology · Aug 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · Novabone Products, LLC · May 2008
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K072265 · Medtronic Sofamor Danek · Jan 2008
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K071187 · Globus Medical, Inc. · Dec 2007