Cleared Special

SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (K061569) - FDA 510(k) Clearance

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

K061569 · Smith & Nephew, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2006
Decision
30d
Days
Class 2
Risk

K061569 is an FDA 510(k) clearance for the SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS. 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 July 6, 2006 after a review of 30 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K061569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2006
Decision Date July 06, 2006
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer

All 11
Devices cleared under the same product code (NPJ) and FDA review panel - the closest regulatory comparables to K061569.
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · Smith & Nephew, Inc. · Dec 2009
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
K070849 · DePuy Orthopaedics, Inc. · Jun 2007
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
K061648 · DePuy Orthopaedics, Inc. · Sep 2006
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
K052265 · Smith & Nephew, Inc. · Dec 2005
STRYKER COMPARTMENTAL KNEE SYSTEM
K052917 · Howmedica Osteonics Corp. · Dec 2005
SMITH & NEPHEW HYBRID KNEE FEMORAL
K042896 · Smith & Nephew, Inc. · Jan 2005