Cleared Traditional

K111944 - NB3D BONE VOID FILLER

K111944 is an FDA 510(k) clearance for NB3D BONE VOID FILLER, manufactured by Pioneer Surgical Technology, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K111944 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Nov 2011
Decision
137d
Days
Class 2
Risk

K111944 is an FDA 510(k) clearance for the NB3D BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 137 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 Pioneer Surgical Technology, Inc. devices

FDA 510(k) Submission Details - K111944

510(k) Number K111944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2011
Decision Date November 22, 2011
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
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 442
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K111944.
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
K112383 · Skeletal Kinetics, LLC · Feb 2012
MTF NEW BONE VOILD FILLER
K113167 · Musculoskeletal Transplant Foundation · Jan 2012
INTERFACE BONE VOID FILLER
K112857 · Biostructures, LLC · Dec 2011
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
K112773 · Novabone Products, LLC · Oct 2011
MTF NEW BONE VOID FILLER
K110003 · Musculoskeletal Transplant Foundation · Oct 2011
INQU PASTE MIX
K111838 · Isto Technologies, Inc. · Sep 2011