Cleared Traditional

K040980 - ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T

K040980 is an FDA 510(k) clearance for ALLOMATRIX C PUTTY, 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.

K040980 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
90d
Days
Class 2
Risk

K040980 is an FDA 510(k) clearance for the ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAF.... 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 July 14, 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 - K040980

510(k) Number K040980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2004
Decision Date July 14, 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 K040980.
TRI-OSTETIC
K041889 · Berkeley Advanced Biomaterials, Inc. · Aug 2004
ALLOMATRIX PUTTY
K041168 · Wrightmedicaltechnologyinc · Aug 2004
NORIAN SRS FAST SET PUTTY
K041842 · Synthes (Usa) · Jul 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755 · Exactech, Inc. · Jun 2004
JAX-TCP
K033552 · Smith & Nephew, Inc. · Jun 2004
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
K040381 · Arthrex, Inc. · May 2004