Cleared Traditional

K071428 - INQU

K071428 is an FDA 510(k) clearance for INQU, manufactured by Isto Technologies, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K071428 · Isto Technologies, Inc. · Orthopedic device
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Sep 2007
Decision
117d
Days
Class 2
Risk

K071428 is an FDA 510(k) clearance for the INQU. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Isto Technologies, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on September 17, 2007 after a review of 117 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 Isto Technologies, Inc. devices

FDA 510(k) Submission Details - K071428

510(k) Number K071428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2007
Decision Date September 17, 2007
Days to Decision 117 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 122d · This submission: 117d
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 308
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K071428.
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
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VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K072184 · Orthovita, Inc. · Sep 2007
BONEMEDIK, AND BONEMEDIK-S
K070897 · Meta Biomed Co., Ltd. · Sep 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630 · Etex Corp. · Jun 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237 · Kensey Nash Corp. · Jun 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007