Cleared Traditional

K061668 - OPTECURE +CCC

K061668 is an FDA 510(k) clearance for OPTECURE +CCC, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K061668

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.

MBP Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K061668.
PLEXUR P
K061982 · Osteotech, Inc. · Feb 2007
DBX STRIP
K062205 · Musculoskeletal Transplant Foundation · Feb 2007
PROGENIX DBM PUTTY AND PASTE
K060794 · Medtronic Sofamor Danek · Dec 2006
BIOSET XC
K060180 · Regeneration Technologies, Inc. · Sep 2006
AFT ALLOGRAFT FILLER TUBE
K060161 · Musculoskeletal Transplant Foundation · Mar 2006
OPTECURE
K050806 · Exactech, Inc. · Feb 2006