Cleared Traditional

K111433 - DEPUY STTUNE (TM) PS KNEE SYSTEM (FDA 510(k) Clearance)

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

K111433 · DePuy Orthopaedics, Inc. · Orthopedic device
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Aug 2011
Decision
99d
Days
Class 2
Risk

K111433 is an FDA 510(k) clearance for the DEPUY STTUNE (TM) PS KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive (product code OIY), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 30, 2011 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K111433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2011
Decision Date August 30, 2011
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OIY Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
Definition Indicated For: 1. Painful And Disabled Knee Joint Resulting From Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis Where One Or More Compartments Are Involved. 2. Correction Of Varus, Valgus, Or Posttraumatic Deformity. 3. Correction Or Revision Of Unsuccessful Osteotomy, Arthrodesis, Or Failure Of Previous Joint Replacement Procedure. For Cemented Use.
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.