Cleared Special

K022615 - CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR

K022615 is an FDA 510(k) clearance for CENTERPULSE, manufactured by Centerpulse Spine-Tech, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Special 510(k) pathway after a 83-day FDA review.

K022615 · Centerpulse Spine-Tech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K022615

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.

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 K022615.
OTI BONE CEMENT PLUG
K030608 · Osteoimplant Technology, Inc. · Jun 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908 · Interpore Cross Intl. · May 2003
CADENCE PEEK CEMEENT RESTRICTOR
K023647 · Spinal Concepts, Inc. · Nov 2002
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