Cleared Special

K012255 - MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR

K012255 is an FDA 510(k) clearance for MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Special 510(k) pathway after a 14-day FDA review.

K012255 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
14d
Days
Class 2
Risk

K012255 is an FDA 510(k) clearance for the MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR. 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 August 1, 2001 after a review of 14 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.

FDA 510(k) Submission Details - K012255

510(k) Number K012255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 18, 2001
Decision Date August 01, 2001
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
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 53
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K012255.
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
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · Medtronic Sofamor Danek USA, Inc. · Aug 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · Medtronic Sofamor Danek, Inc. · Jul 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718 · Medtronic Sofamor Danek, Inc. · Feb 2001
RABEA DEVICE, MODEL PXXXXXX
K990345 · Signus Medizintechnik GmbH · Jul 1999
K012255 · MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
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