Cleared Traditional

ALLOMATRIX CUSTOM (K053319) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 199
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K053319.
MODIFICATION TO ALLOMATRIX CUSTOM
K061939 · Wrightmedicaltechnologyinc · Jul 2006
NORIAN SRS BONE VOID FILLER
K060408 · Synthes (Usa) · Mar 2006
NORIAN SRS FAST SET PUTTY
K060406 · Synthes (Usa) · Mar 2006
MIIG SR
K060011 · Wrightmedicaltechnologyinc · Feb 2006
MASTERGRAFT PUTTY BONE VOID FILLER
K051386 · Medtronic Vascular · Dec 2005
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005