Cleared Traditional

MaxiGen (K152077) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152077 · Hans Biomed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
269d
Days
Class 2
Risk

K152077 is an FDA 510(k) clearance for the MaxiGen. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Hans Biomed Corp. (Daejeon, KR). The FDA issued a Cleared decision on April 21, 2016 after a review of 269 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 Hans Biomed Corp. devices

Submission Details

510(k) Number K152077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2015
Decision Date April 21, 2016
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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 183
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K152077.
ABCcolla Bone Graft
K171629 · Acro Biomedical Co., Ltd. · Feb 2018
BioSphere MIS Putty (BioSphere MIS)
K173301 · Synergy Biomedical, LLC · Jan 2018
NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
AS20 COMPOSITE GRAFT
K141746 · Wrightmedicaltechnologyinc · Aug 2014
ULTRAFUSE
K130531 · Baxter Healthcare Corp · Apr 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656 · Wrightmedicaltechnologyinc · Mar 2014