Cleared Traditional

K140844 - BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC

K140844 is an FDA 510(k) clearance for BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, manufactured by Synergy Biomedical, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K140844 · Synergy Biomedical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
105d
Days
Class 2
Risk

K140844 is an FDA 510(k) clearance for the BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Synergy Biomedical, Inc. (Washington, US). The FDA issued a Cleared decision on July 16, 2014 after a review of 105 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.

FDA 510(k) Submission Details - K140844

510(k) Number K140844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2014
Decision Date July 16, 2014
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K140844.
SKAFFOLD NMX BONE VOID FILLER
K132211 · Skeletal Kinetics, LLC · Aug 2014
AS20 COMPOSITE GRAFT
K141746 · Wrightmedicaltechnologyinc · Aug 2014
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
K141841 · Integra Lifescience Corportation · Aug 2014
SOLUM IV BONE VOID FILLER
K132470 · Spinesmith Partners, Llp · May 2014
OSTEOSPAN MORPHEUS
K132377 · Biogennix, LLC · May 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
K140844 · BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
Download PDF FDA Summary Synergy Biomedical, I…