Cleared Traditional

K110925 - NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT

K110925 is an FDA 510(k) clearance for NOVABONE MACROPOR-SI+ - BIOACTIVE BONE ..., manufactured by Novabone Products, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K110925 · Novabone Products, LLC · Orthopedic device
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Jul 2011
Decision
95d
Days
Class 2
Risk

K110925 is an FDA 510(k) clearance for the NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Novabone Products, LLC (Alachua, US). The FDA issued a Cleared decision on July 5, 2011 after a review of 95 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 Novabone Products, LLC devices

FDA 510(k) Submission Details - K110925

510(k) Number K110925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2011
Decision Date July 05, 2011
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 435
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K110925.
MTF NEW BONE VOID FILLER
K110003 · Musculoskeletal Transplant Foundation · Oct 2011
INQU PASTE MIX
K111838 · Isto Technologies, Inc. · Sep 2011
INQU PASTE MIX PLUS
K103799 · Isto Technologies, Inc. · Aug 2011
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
K110976 · Nanotherapeutics, Inc. · May 2011
FORTROSS BONE VOID FILLER
K110561 · Pioneer Surgical Technology · Apr 2011
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
K110787 · Orthogem Limited · Apr 2011