Cleared Traditional

K040889 - EXACTECH OPTETRAK UNICONDYLAR KNEE

K040889 is an FDA 510(k) clearance for EXACTECH OPTETRAK UNICONDYLAR KNEE, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 179-day FDA review.

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

FDA 510(k) Submission Details - K040889

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
Combination Product No
PCCP Authorized No
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.

HRY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 84
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K040889.
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
K051721 · Global Orthopaedic Technology, USA, Inc. · Oct 2005
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
K050764 · Corin USA · Aug 2005
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · Biomet, Inc. · Nov 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268 · DePuy Orthopaedics, Inc. · May 2004
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052 · Plus Orthopedics · Jul 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446 · Biomet, Inc. · Mar 2003