Cleared Special

CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR (K022615) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K022615 · Centerpulse Spine-Tech, Inc. · Orthopedic device
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Oct 2002
Decision
83d
Days
Class 2
Risk

K022615 is an FDA 510(k) clearance for the CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Centerpulse Spine-Tech, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 29, 2002 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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 Centerpulse Spine-Tech, Inc. devices

Submission Details

510(k) Number K022615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 07, 2002
Decision Date October 29, 2002
Days to Decision 83 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 12
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K022615.
Mectaplug PE II
K210062 · Medacta International S.A. · Apr 2021
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · Exactech, Inc. · Aug 2002
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · Medtronic Sofamor Danek USA, Inc. · Oct 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · Medtronic Sofamor Danek USA, Inc. · Aug 2001
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · Osteonics Corp. · Oct 1992