Cleared Traditional

K061668 - OPTECURE +CCC

K061668 is the FDA 510(k) clearance for OPTECURE +CCC by Exactech, Inc.. It is a Class 2 Orthopedic device (product code MBP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K061668 · Exactech, Inc. · Orthopedic device
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Sep 2006
Decision
90d
Days
Class 2
Risk

K061668 is an FDA 510(k) clearance for the OPTECURE +CCC. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 12, 2006 after a review of 90 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 Exactech, Inc. devices

Submission Details

510(k) Number K061668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2006
Decision Date September 12, 2006
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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 - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 7
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K061668.
OPTECURE
K063685 · Exactech, Inc. · Jun 2007
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
K061131 · Orthocon, Inc. · Feb 2007
PROGENIX DBM PUTTY AND PASTE
K060794 · Medtronic Sofamor Danek · Dec 2006
OPTECURE
K050806 · Exactech, Inc. · Feb 2006
OSTEOSET DBM PELLETS
K053642 · Wrightmedicaltechnologyinc · Jan 2006