Cleared Traditional

K122868 - BIOSPHERE BIOACTIVE BONE GRAFT PUTTY

K122868 is an FDA 510(k) clearance for BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, manufactured by Synergy Biomedical, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K122868 · Synergy Biomedical, LLC · Orthopedic device
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Apr 2013
Decision
213d
Days
Class 2
Risk

K122868 is an FDA 510(k) clearance for the BIOSPHERE BIOACTIVE BONE GRAFT PUTTY. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Synergy Biomedical, LLC (Washington, US). The FDA issued a Cleared decision on April 19, 2013 after a review of 213 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 Synergy Biomedical, LLC devices

FDA 510(k) Submission Details - K122868

510(k) Number K122868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2012
Decision Date April 19, 2013
Days to Decision 213 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
91d slower than avg
Panel avg: 122d · This submission: 213d
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 425
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K122868.
KINEX BIOACTIVE
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NEOTIS
K130953 · Sbm Sciences For Bio Materials · Jul 2013
MASTERGRAFT STRIP
K130335 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 2013
BETA-TCP GRANULES
K120354 · Skeletal Kinetics, LLC · Mar 2013