Cleared Traditional

K141725 - BONGOLD BONE GRAFT MATERIAL

K141725 is an FDA 510(k) clearance for BONGOLD BONE GRAFT MATERIAL, manufactured by Beijing Allgens Medical Science & Technology Co, L. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K141725 · Beijing Allgens Medical Science & Technology Co, L · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
378d
Days
Class 2
Risk

K141725 is an FDA 510(k) clearance for the BONGOLD BONE GRAFT MATERIAL. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Beijing Allgens Medical Science & Technology Co, L (Basking Ridge, US). The FDA issued a Cleared decision on July 9, 2015 after a review of 378 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 Beijing Allgens Medical Science & Technology Co, L devices

FDA 510(k) Submission Details - K141725

510(k) Number K141725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2014
Decision Date July 09, 2015
Days to Decision 378 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
256d slower than avg
Panel avg: 122d · This submission: 378d
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 K141725.
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
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · Biocomposites, Ltd. · Jan 2015
NOVABONE BIOACTIVE STRIP
K141207 · Novabone Products, LLC · Oct 2014
MASTERGRAFT MATRIX EXT
K141824 · Medtronic Sofamor Danek, Inc. · Sep 2014