Cleared Traditional

K033272 - DEPUY SIGMA TIBIAL INSERTS

K033272 is an FDA 510(k) clearance for DEPUY SIGMA TIBIAL INSERTS, 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 118-day FDA review.

K033272 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
118d
Days
Class 2
Risk

K033272 is an FDA 510(k) clearance for the DEPUY SIGMA TIBIAL INSERTS. 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 February 5, 2004 after a review of 118 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 - K033272

510(k) Number K033272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2003
Decision Date February 05, 2004
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K033272.
VANGUARD PATELLA COMPONENTS
K040770 · Biomet Manufacturing, Inc. · Apr 2004
DEPUY SIGMA XLK TIBIAL INSERTS
K040166 · DePuy Orthopaedics, Inc. · Feb 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI
K033883 · Exactech, Inc. · Feb 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342 · Howmedica Osteonics Corp. · Jan 2004
ADVANCE DOUBLE HIGH INSERT
K033890 · Wrightmedicaltechnologyinc · Jan 2004
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
K031962 · Implex Corp. · Jan 2004