Cleared Traditional

K043005 - MODIFICATION TO MBCP

K043005 is an FDA 510(k) clearance for MODIFICATION TO MBCP, manufactured by Biomatlante. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K043005 · Biomatlante · Orthopedic device
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May 2005
Decision
183d
Days
Class 2
Risk

K043005 is an FDA 510(k) clearance for the MODIFICATION TO MBCP. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biomatlante (Vigneux De Bretagne, FR). The FDA issued a Cleared decision on May 3, 2005 after a review of 183 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.

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FDA 510(k) Submission Details - K043005

510(k) Number K043005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date May 03, 2005
Days to Decision 183 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
61d slower than avg
Panel avg: 122d · This submission: 183d
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K043005.
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · Novabone Products, LLC · Nov 2005
OSTEOCURE RESORBABLE BEAD KIT
K051406 · Nexa Orthopedics, Inc. · Aug 2005
AFT
K042125 · Musculoskeletal Transplant Foundation · Jul 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
K040262 · Musculoskeletal Transplant Foundation · Mar 2005
INTERGRO DBM
K031399 · Interpore Cross Intl. · Feb 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · Depuy Spine, Inc. · Feb 2005