Cleared Abbreviated

K052265 - SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (FDA 510(k) Clearance)

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

K052265 · Smith & Nephew, Inc. · Orthopedic device
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Dec 2005
Decision
130d
Days
Class 2
Risk

K052265 is an FDA 510(k) clearance for the SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL. Classified as Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer (product code NPJ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on December 27, 2005 after a review of 130 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K052265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2005
Decision Date December 27, 2005
Days to Decision 130 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
Definition The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement.
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.