Cleared Traditional

K040889 - EXACTECH OPTETRAK UNICONDYLAR KNEE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040889 · Exactech, Inc. · Orthopedic device
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Oct 2004
Decision
179d
Days
Class 2
Risk

K040889 is an FDA 510(k) clearance for the EXACTECH OPTETRAK UNICONDYLAR KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 1, 2004 after a review of 179 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 K040889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date October 01, 2004
Days to Decision 179 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 122d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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.