Cleared Traditional

K063346 - PRO OSTEON 500R

K063346 is an FDA 510(k) clearance for PRO OSTEON 500R, manufactured by Ebi, L.P.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K063346 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
166d
Days
Class 2
Risk

K063346 is an FDA 510(k) clearance for the PRO OSTEON 500R. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on April 18, 2007 after a review of 166 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 Ebi, L.P. devices

FDA 510(k) Submission Details - K063346

510(k) Number K063346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2006
Decision Date April 18, 2007
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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 K063346.
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INQU
K063359 · Isto Technologies, Inc. · Apr 2007
OSTEOFIX BONE VOID FILLER
K070220 · Calcitec, Inc. · Apr 2007
ORIGEN DBM WITH BIOACTIVE GLASS
K062459 · Nanotherapeutics · Feb 2007