Cleared Traditional

K063633 - DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES

K063633 is an FDA 510(k) clearance for DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL ..., manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K063633 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
86d
Days
Class 2
Risk

K063633 is an FDA 510(k) clearance for the DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEA.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 2, 2007 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K063633

510(k) Number K063633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2006
Decision Date March 02, 2007
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 908
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K063633.
MODIFICATION TO SCORPIO NRG KNEE SYSTEM
K071991 · Howmedica Osteonics Corp. · Aug 2007
TRIATHLON TS KNEE SYSTEM
K070095 · Howmedica Osteonics Corp. · Jun 2007
COLUMBUS TOTAL KNEE SYSTEM AS
K071220 · Aesculap Implant Systems, Inc. · Jun 2007
TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
K063423 · Howmedica Osteonics · Jan 2007
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
K063211 · Stelkast Company · Jan 2007
MICROPLASTY TIBIAL TRAYS
K063732 · Biomet Manufacturing Corp · Jan 2007