Cleared Traditional

K110003 - MTF NEW BONE VOID FILLER

K110003 is an FDA 510(k) clearance for MTF NEW BONE VOID FILLER, manufactured by Musculoskeletal Transplant Foundation. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K110003 · Musculoskeletal Transplant Foundation · Orthopedic device
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Oct 2011
Decision
283d
Days
Class 2
Risk

K110003 is an FDA 510(k) clearance for the MTF NEW BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on October 13, 2011 after a review of 283 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 Musculoskeletal Transplant Foundation devices

FDA 510(k) Submission Details - K110003

510(k) Number K110003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date October 13, 2011
Days to Decision 283 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
161d slower than avg
Panel avg: 122d · This submission: 283d
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 398
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K110003.
INTERFACE BONE VOID FILLER
K112857 · Biostructures, LLC · Dec 2011
NB3D BONE VOID FILLER
K111944 · Pioneer Surgical Technology, Inc. · Nov 2011
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
K112773 · Novabone Products, LLC · Oct 2011
INQU PASTE MIX
K111838 · Isto Technologies, Inc. · Sep 2011
INQU PASTE MIX PLUS
K103799 · Isto Technologies, Inc. · Aug 2011
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925 · Novabone Products, LLC · Jul 2011