Cleared Traditional

K020344 - RPX TITANIUM CEMNT RESTRICTOR

K020344 is an FDA 510(k) clearance for RPX TITANIUM CEMNT RESTRICTOR, manufactured by Sulzer Spine-Tech. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020344 · Sulzer Spine-Tech · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
90d
Days
Class 2
Risk

K020344 is an FDA 510(k) clearance for the RPX TITANIUM CEMNT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Sulzer Spine-Tech (Minneapolis, US). The FDA issued a Cleared decision on May 2, 2002 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 878.3300 - 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 Sulzer Spine-Tech devices

FDA 510(k) Submission Details - K020344

510(k) Number K020344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2002
Decision Date May 02, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

JDK Device Classification - Class 2, Special Controls

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - JDK Prosthesis, Hip, Cement Restrictor

All 38
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K020344.
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · Exactech, Inc. · Aug 2002
FORTITUDE CEMENT RESTRICTOR
K021719 · Spinal Concepts, Inc. · Aug 2002
CADENCE CEMENT RESTRICTOR
K022218 · Spinal Concepts, Inc. · Aug 2002
CEMENT RESTRICTOR
K013663 · Medtronic Sofamor Danek, Inc. · Dec 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · Medtronic Sofamor Danek USA, Inc. · Oct 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · Medtronic Sofamor Danek, Inc. · Oct 2001