Cleared Traditional

K040381 - HATRIC

K040381 is the FDA 510(k) clearance for HATRIC by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K040381 · Arthrex, Inc. · Orthopedic device
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May 2004
Decision
85d
Days
Class 2
Risk

K040381 is an FDA 510(k) clearance for the HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 12, 2004 after a review of 85 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 Arthrex, Inc. devices

Submission Details

510(k) Number K040381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date May 12, 2004
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K040381.
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T
K040980 · Wrightmedicaltechnologyinc · Jul 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755 · Exactech, Inc. · Jun 2004
JAX-TCP
K033552 · Smith & Nephew, Inc. · Jun 2004
CALCIGEN -NAP BONE VOID FILLER
K033611 · Biomet, Inc. · Apr 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828 · Wrightmedicaltechnologyinc · Apr 2004
ALLOMATRIX MODEL# 86
K020895 · Wrightmedicaltechnologyinc · Mar 2004