Cleared Traditional

BellaFuse (K151271) - FDA 510(k) Clearance

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

K151271 · Hans Biomed Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2016
Decision
303d
Days
Class 2
Risk

K151271 is an FDA 510(k) clearance for the BellaFuse. 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 March 11, 2016 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K151271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date March 11, 2016
Days to Decision 303 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
181d slower than avg
Panel avg: 122d · This submission: 303d
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 K151271.
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