Cleared Special

K110547 - OPTERTRAK LOGIC PSC TIBIAL INSERT

K110547 is an FDA 510(k) clearance for OPTERTRAK LOGIC PSC TIBIAL INSERT, manufactured by Exactech Sarasota. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 48-day FDA review.

K110547 · Exactech Sarasota · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
48d
Days
Class 2
Risk

K110547 is an FDA 510(k) clearance for the OPTERTRAK LOGIC PSC TIBIAL INSERT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Exactech Sarasota (Gainesville, US). The FDA issued a Cleared decision on April 14, 2011 after a review of 48 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.

FDA 510(k) Submission Details - K110547

510(k) Number K110547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date April 14, 2011
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

JWH Device Classification - Class 2, Special Controls

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 913
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K110547.
GMK REVISION HYBRID LINERS
K111283 · Medacta International · May 2011
HLS KNEETEC SYSTEM
K094013 · Tornier · May 2011
REVISION PROTHESIS
K110837 · Smith & Nephew, Inc. · Apr 2011
APEX PS KNEE SYSTEM
K102578 · Omni Life Science, Inc. · Mar 2011
GMK REVISION KNEE SC LINERS
K103170 · Medacta International S.A. · Mar 2011
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
K103837 · Ortho Development · Mar 2011