Cleared Traditional

K090310 - EQUIVABONE

K090310 is an FDA 510(k) clearance for EQUIVABONE, manufactured by Etex Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K090310 · Etex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
46d
Days
Class 2
Risk

K090310 is an FDA 510(k) clearance for the EQUIVABONE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on March 24, 2009 after a review of 46 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 Etex Corp. devices

FDA 510(k) Submission Details - K090310

510(k) Number K090310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2009
Decision Date March 24, 2009
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
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 301
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K090310.
MASTERGRAFT STRIP
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INTERGRO DBM
K082793 · Biomet Spine · Apr 2009
GAMMA-BSM, BETA-BSM
K090242 · Etex Corp. · Feb 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008