Cleared Special

K061569 - SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS

K061569 is an FDA 510(k) clearance for SMITH & NEPHEW COMPETITOR DEUCE FEMORAL..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code NPJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K061569 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K061569

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.

NPJ Device Classification - Class 2, Special Controls

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.
RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
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DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
K061648 · DePuy Orthopaedics, Inc. · Sep 2006
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
K053488 · Conformis, Inc. · Mar 2006
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
K052265 · Smith & Nephew, Inc. · Dec 2005
STRYKER COMPARTMENTAL KNEE SYSTEM
K052917 · Howmedica Osteonics Corp. · Dec 2005
K061569 · SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
Download PDF FDA Summary Smith & Nephew, Inc.