Cleared Traditional

K132656 - PRODENSE BONE GRAFT SUBSTITUTE

K132656 is an FDA 510(k) clearance for PRODENSE BONE GRAFT SUBSTITUTE, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K132656 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
210d
Days
Class 2
Risk

K132656 is an FDA 510(k) clearance for the PRODENSE BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 24, 2014 after a review of 210 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K132656

510(k) Number K132656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2013
Decision Date March 24, 2014
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 431
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K132656.
OSTEOSPAN MORPHEUS
K132377 · Biogennix, LLC · May 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
ULTRAFUSE
K130531 · Baxter Healthcare Corp · Apr 2014
BG MORSELS
K132805 · Prosidyan, Inc. · Mar 2014
NB3D BONE VOID FILLER
K132050 · Pioneer Surgical Technology, Inc. · Feb 2014
BIOACTIVE BONE GRAFT PUTTY
K132071 · Biostructures, LLC · Jan 2014