Cleared Traditional

K122868 - BIOSPHERE BIOACTIVE BONE GRAFT PUTTY

K122868 is the FDA 510(k) clearance for BIOSPHERE BIOACTIVE BONE GRAFT PUTTY by Synergy Biomedical, LLC. It is a Class 2 Orthopedic device (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

Submission Details

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
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.

Device Classification

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 234
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K122868.
SIGNIFY BIOACTIVE
K130977 · Globus Medical, Inc. · Dec 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · Medtronic Sofamor Danek USA, Inc. · Oct 2013
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