Cleared Traditional

K121313 - MTF NEW BONE VOID FILLER

K121313 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 254-day FDA review.

K121313 · Musculoskeletal Transplant Foundation · Orthopedic device
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Jan 2013
Decision
254d
Days
Class 2
Risk

K121313 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 January 11, 2013 after a review of 254 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 - K121313

510(k) Number K121313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date January 11, 2013
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 K121313.
BETA-TCP GRANULES
K120354 · Skeletal Kinetics, LLC · Mar 2013
A-GRIX TE RESORABLE BONE VOID FILLER
K121453 · Ag Digital Technology Corp. · Feb 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · Medtronic Sofamor Danek, Inc. · 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
BICERA (TM) RESORBABLE BONE SUBSTITUTE
K110949 · Wiltrom Corporation Limited · Sep 2012
KENSEY NASH BONE VOID FILLER XC
K120141 · Kensey Nash Cororation · May 2012