Cleared Traditional

K053319 - ALLOMATRIX CUSTOM

K053319 is an FDA 510(k) clearance for ALLOMATRIX CUSTOM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K053319 · Wrightmedicaltechnologyinc · Orthopedic device
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Mar 2006
Decision
96d
Days
Class 2
Risk

K053319 is an FDA 510(k) clearance for the ALLOMATRIX CUSTOM. 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 March 6, 2006 after a review of 96 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 - K053319

510(k) Number K053319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2005
Decision Date March 06, 2006
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
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 444
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K053319.
NORIAN SRS FAST SET PUTTY
K060406 · Synthes (Usa) · Mar 2006
COLLOSS E BONE VOID FILLER
K051047 · Ossacur AG · Mar 2006
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
K051617 · Novabone Products, LLC · Mar 2006
STRYKER INJECTABLE CEMENT
K060061 · Stryker Corp. · Mar 2006
MIIG SR
K060011 · Wrightmedicaltechnologyinc · Feb 2006
THERIGRAFT TCP PUTTY BONE VOID FILLER
K053228 · Therics, LLC · Jan 2006