Cleared Traditional

K151271 - BellaFuse

K151271 is an FDA 510(k) clearance for BellaFuse, manufactured by Hans Biomed Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K151271 · Hans Biomed Corp. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K151271

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.

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 307
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K151271.
Vitoss Bioactive (BA) Injectable
K163621 · Orthovita, Inc. · May 2017
NovaBone IRM
K163310 · Novabone Products, LLC · Jan 2017
HydroSet XT
K161447 · Orthovita, Inc. · Oct 2016
Vitoss BiModal Bone Graft Substitute Foam Strip
K153608 · Orthovita, Inc. · Feb 2016
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
K152071 · Novabone Products, LLC · Aug 2015
MASTERGRAFT Contain
K151172 · Medtronic Sofamor Danek USA, Inc. · Aug 2015