Cleared Special

K013014 - BLOCK CEMENT RESTRICTOR (CR) - TITANIUM

K013014 is the FDA 510(k) clearance for BLOCK CEMENT RESTRICTOR (CR) - TITANIUM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code JDK) cleared through the Special 510(k) pathway after a 27-day FDA review.

K013014 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Oct 2001
Decision
27d
Days
Class 2
Risk

K013014 is an FDA 510(k) clearance for the BLOCK CEMENT RESTRICTOR (CR) - TITANIUM. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on October 4, 2001 after a review of 27 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 Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K013014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 07, 2001
Decision Date October 04, 2001
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 30
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K013014.
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
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · Medtronic Sofamor Danek USA, Inc. · Aug 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · Medtronic Sofamor Danek, Inc. · Aug 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · Medtronic Sofamor Danek, Inc. · Jul 2001