Cleared Traditional

K063685 - OPTECURE

Also marketed or referenced as:
OPTECURE + CCC

K063685 is an FDA 510(k) clearance for OPTECURE, 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 177-day FDA review.

K063685 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
177d
Days
Class 2
Risk

K063685 is an FDA 510(k) clearance for the OPTECURE. 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 June 7, 2007 after a review of 177 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 Exactech, Inc. devices

FDA 510(k) Submission Details - K063685

510(k) Number K063685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2006
Decision Date June 07, 2007
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
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 K063685.
SYGNAL DBM
K080405 · Musculoskeletal Transplant Foundation · Aug 2008
CAP PLUS, EQUIVABONE, CAP/DBM
K080329 · Etex Corp. · Apr 2008
SYGNAL DBM
K073329 · Musculoskeletal Transplant Foundation · Feb 2008
DBX DEMINERALIZED BONE MATRIX MIX
K063676 · Musculoskeletal Transplant Foundation · Mar 2007
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
K061131 · Orthocon, Inc. · Feb 2007
PLEXUR P
K061982 · Osteotech, Inc. · Feb 2007