Cleared Traditional

K062630 - OSSIPRO BONE SUBSTITUTE MATERIAL

K062630 is an FDA 510(k) clearance for OSSIPRO BONE SUBSTITUTE MATERIAL, 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 296-day FDA review.

K062630 · Etex Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
296d
Days
Class 2
Risk

K062630 is an FDA 510(k) clearance for the OSSIPRO BONE SUBSTITUTE MATERIAL. 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 June 28, 2007 after a review of 296 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.

FDA 510(k) Submission Details - K062630

510(k) Number K062630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date June 28, 2007
Days to Decision 296 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
174d slower than avg
Panel avg: 122d · This submission: 296d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K062630.
TRIPORE, MODELS HA, BP90, BP15
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K071237 · Kensey Nash Corp. · Jun 2007
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
K071206 · Apatech , Ltd. · May 2007