Cleared Traditional

BONGOLD BONE GRAFT MATERIAL (K141725) - FDA 510(k) Clearance

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

K141725 · Beijing Allgens Medical Science & Technology Co, L · Orthopedic device
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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

Submission Details

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.

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 190
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K141725.
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
CONFIRM BIOACTIVE
K133678 · Globus Medical, Inc. · Aug 2014
AS20 COMPOSITE GRAFT
K141746 · Wrightmedicaltechnologyinc · Aug 2014
ULTRAFUSE
K130531 · Baxter Healthcare Corp · Apr 2014