Cleared Traditional

AS20 COMPOSITE GRAFT (K141746) - FDA 510(k) Clearance

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

K141746 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2014
Decision
35d
Days
Class 2
Risk

K141746 is an FDA 510(k) clearance for the AS20 COMPOSITE GRAFT. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on August 4, 2014 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K141746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2014
Decision Date August 04, 2014
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
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 182
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K141746.
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
ULTRAFUSE
K130531 · Baxter Healthcare Corp · Apr 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656 · Wrightmedicaltechnologyinc · Mar 2014
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 2013