Cleared Traditional

K141830 - STIMULAN KIT

K141830 is the FDA 510(k) clearance for STIMULAN KIT by Biocomposites, Ltd.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K141830 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
200d
Days
Class 2
Risk

K141830 is an FDA 510(k) clearance for the STIMULAN KIT, STIMULAN RAPID CURE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on January 23, 2015 after a review of 200 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 Biocomposites, Ltd. devices

Submission Details

510(k) Number K141830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date January 23, 2015
Days to Decision 200 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
78d slower than avg
Panel avg: 122d · This submission: 200d
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 232
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K141830.
NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
Resorbable Mesh Device
K172130 · SeaSpine Orthopedics Corporation · Nov 2017
MASTERGRAFT Contain
K151172 · Medtronic Sofamor Danek USA, Inc. · Aug 2015
MASTERGRAFT MATRIX EXT
K141824 · Medtronic Sofamor Danek, Inc. · Sep 2014
CONFIRM BIOACTIVE
K133678 · Globus Medical, Inc. · Aug 2014
AS20 COMPOSITE GRAFT
K141746 · Wrightmedicaltechnologyinc · Aug 2014