Cleared Traditional

K041663 - ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM

K041663 is an FDA 510(k) clearance for ALLOMATRIX TCP, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K041663 · Wrightmedicaltechnologyinc · Orthopedic device
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Sep 2004
Decision
90d
Days
Class 2
Risk

K041663 is an FDA 510(k) clearance for the ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on September 16, 2004 after a review of 90 days - within the typical 510(k) review window.

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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K041663

510(k) Number K041663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2004
Decision Date September 16, 2004
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 448
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K041663.
BIOPLUS
K042636 · Berkeley Advanced Biomaterials, Inc. · Dec 2004
KASIOS TCP
K042340 · Kasios Biomaterials · Nov 2004
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
K042305 · Ossacur AG · Oct 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · Biomet Manufacturing, Inc. · Aug 2004
NAME BONE VOID FILLER
K041421 · Stryker Biotech · Aug 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613 · Novabone Products, LLC · Aug 2004