Cleared Traditional

K132805 - BG MORSELS

K132805 is an FDA 510(k) clearance for BG MORSELS, manufactured by Prosidyan, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K132805 · Prosidyan, Inc. · Orthopedic device
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Mar 2014
Decision
189d
Days
Class 2
Risk

K132805 is an FDA 510(k) clearance for the BG MORSELS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Prosidyan, Inc. (Philedelphia, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 189 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 Prosidyan, Inc. devices

FDA 510(k) Submission Details - K132805

510(k) Number K132805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2013
Decision Date March 14, 2014
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 291
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K132805.
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
ULTRAFUSE
K130531 · Baxter Healthcare Corp · Apr 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656 · Wrightmedicaltechnologyinc · Mar 2014
NB3D BONE VOID FILLER
K132050 · Pioneer Surgical Technology, Inc. · Feb 2014
SIGNIFY BIOACTIVE
K130977 · Globus Medical, Inc. · Dec 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · Medtronic Sofamor Danek USA, Inc. · Oct 2013