Cleared Traditional

K113167 - MTF NEW BONE VOILD FILLER

K113167 is an FDA 510(k) clearance for MTF NEW BONE VOILD 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 89-day FDA review.

K113167 · Musculoskeletal Transplant Foundation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
89d
Days
Class 2
Risk

K113167 is an FDA 510(k) clearance for the MTF NEW BONE VOILD 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 January 24, 2012 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Musculoskeletal Transplant Foundation devices

FDA 510(k) Submission Details - K113167

510(k) Number K113167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2011
Decision Date January 24, 2012
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 K113167.
B-GENIN, R-GENIN
K113791 · Berkeley Advanced Biomaterials, Inc. · Mar 2012
POLYFUSE - NEUROBONE
K111018 · Atpac Medical, LLC · Feb 2012
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
K112383 · Skeletal Kinetics, LLC · Feb 2012
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