Cleared Traditional

K073214 - DUOWEDGE SYNTHETIC BONE SUBSTITUTE

K073214 is an FDA 510(k) clearance for DUOWEDGE SYNTHETIC BONE SUBSTITUTE, manufactured by Kasios. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 748-day FDA review.

K073214 · Kasios · Orthopedic device
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Dec 2009
Decision
748d
Days
Class 2
Risk

K073214 is an FDA 510(k) clearance for the DUOWEDGE SYNTHETIC BONE SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Kasios (Round Rock, US). The FDA issued a Cleared decision on December 1, 2009 after a review of 748 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Kasios devices

FDA 510(k) Submission Details - K073214

510(k) Number K073214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2007
Decision Date December 01, 2009
Days to Decision 748 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
626d slower than avg
Panel avg: 122d · This submission: 748d
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K073214.
NANOSS BONE VOID FILLER
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ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091607 · Etex Corp. · Nov 2009
KAINOS+
K090387 · Signus Medizintechnik GmbH · Sep 2009