Cleared Special

K013350 - MODIFICATION TO DEPUY C-STEM SYSTEM

K013350 is an FDA 510(k) clearance for MODIFICATION TO DEPUY C-STEM SYSTEM, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 29-day FDA review.

K013350 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
29d
Days
Class 2
Risk

K013350 is an FDA 510(k) clearance for the MODIFICATION TO DEPUY C-STEM SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K013350

510(k) Number K013350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date November 07, 2001
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K013350.
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291 · Exactech, Inc. · Feb 2002
PATRIOT PROTRUSIO CAGE
K020076 · Biomet Orthopedics, Inc. · Jan 2002
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · DePuy Orthopaedics, Inc. · Dec 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · Sulzer Orthopedics, Inc. · Oct 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · Exactech, Inc. · Aug 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · Biomet, Inc. · Jul 2001