Cleared Special

OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES (K012251) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012251 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
13d
Days
Class 2
Risk

K012251 is an FDA 510(k) clearance for the OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K012251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2001
Decision Date July 31, 2001
Days to Decision 13 days
Submission Type Special
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
109d faster than avg
Panel avg: 122d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K012251.
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K013991 · Zimmer, Inc. · Dec 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · Howmedica Osteonics Corp. · Nov 2001
MAXIM RPG PS FEMORAL COMPONENT
K012348 · Biomet, Inc. · Aug 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · Exactech, Inc. · Jul 2001
SCORPIO CR SUPERFLEX TIBIAL INSERT
K011643 · Howmedica Osteonics Corp. · Jun 2001
ORTHOGENESIS LPS SYSTEM
K003182 · Depuy, Inc. · Jun 2001