Cleared Traditional

K072170 - WELLGRAFT PE II

K072170 is an FDA 510(k) clearance for WELLGRAFT PE II, manufactured by Gwowei Technology Co., Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K072170 · Gwowei Technology Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
242d
Days
Class 2
Risk

K072170 is an FDA 510(k) clearance for the WELLGRAFT PE II. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Gwowei Technology Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on April 4, 2008 after a review of 242 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 Gwowei Technology Co., Ltd. devices

FDA 510(k) Submission Details - K072170

510(k) Number K072170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date April 04, 2008
Days to Decision 242 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
120d slower than avg
Panel avg: 122d · This submission: 242d
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K072170.
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
K081439 · Orthovita, Inc. · Jun 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · Novabone Products, LLC · May 2008
PLEXUR-P
K080511 · Osteotech, Inc. · Apr 2008
PLEXUR M
K073405 · Osteotech, Inc. · Mar 2008
PROGENIX DMB PUTTY
K072265 · Medtronic Sofamor Danek · Jan 2008
MICROFUSE BONE VOID FILLER
K071187 · Globus Medical, Inc. · Dec 2007