Cleared Traditional

K061648 - DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)

K061648 is an FDA 510(k) clearance for DEPUY GRADUATED COMPARTMENTAL KNEE (GCK), manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code NPJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K061648 · DePuy Orthopaedics, Inc. · Orthopedic device
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Sep 2006
Decision
90d
Days
Class 2
Risk

K061648 is an FDA 510(k) clearance for the DEPUY GRADUATED COMPARTMENTAL KNEE (GCK). Classified as Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer (product code NPJ), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 11, 2006 after a review of 90 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

FDA 510(k) Submission Details - K061648

510(k) Number K061648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2006
Decision Date September 11, 2006
Days to Decision 90 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 9
Devices cleared under the same product code (NPJ) and FDA review panel - the closest regulatory comparables to K061648.
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
K093513 · Conformis, Inc. · Dec 2009
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
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
K061569 · Smith & Nephew, Inc. · Jul 2006
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
K053488 · Conformis, Inc. · Mar 2006
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
K052265 · Smith & Nephew, Inc. · Dec 2005