Cleared Traditional

K061499 - OSFERION

K061499 is an FDA 510(k) clearance for OSFERION, manufactured by Olympus America, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K061499 · Olympus America, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
240d
Days
Class 2
Risk

K061499 is an FDA 510(k) clearance for the OSFERION. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Olympus America, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 26, 2007 after a review of 240 days - an extended review 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: 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 Olympus America, Inc. devices

FDA 510(k) Submission Details - K061499

510(k) Number K061499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2006
Decision Date January 26, 2007
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
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 441
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K061499.
OSTEOFIX BONE VOID FILLER
K070220 · Calcitec, Inc. · Apr 2007
ORIGEN DBM WITH BIOACTIVE GLASS
K062459 · Nanotherapeutics · Feb 2007
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
K062200 · Collagen Matrix, Inc. · Feb 2007
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
K063124 · Integra Lifesciences Corp. · Jan 2007
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
K053218 · Musculoskeletal Transplant Foundation · Dec 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353 · Integra LifeSciences Corporation · Dec 2006