Cleared Traditional

K121453 - A-GRIX TE RESORABLE BONE VOID FILLER

K121453 is an FDA 510(k) clearance for A-GRIX TE RESORABLE BONE VOID FILLER, manufactured by Ag Digital Technology Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K121453 · Ag Digital Technology Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
265d
Days
Class 2
Risk

K121453 is an FDA 510(k) clearance for the A-GRIX TE RESORABLE BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ag Digital Technology Corp. (Flagstaff, US). The FDA issued a Cleared decision on February 5, 2013 after a review of 265 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 Ag Digital Technology Corp. devices

FDA 510(k) Submission Details - K121453

510(k) Number K121453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2012
Decision Date February 05, 2013
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
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 307
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K121453.
KINEX BIOACTIVE
K130392 · Globus Medical, Inc. · Aug 2013
MASTERGRAFT STRIP
K130335 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · Medtronic Sofamor Danek, Inc. · Jan 2013
MTF NEW BONE VOID FILLER
K121313 · Musculoskeletal Transplant Foundation · Jan 2013
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
K121989 · Exactech, Inc. · Nov 2012