Cleared Traditional

K003718 - TITANIUM CEMENT RESTRICTOR (TCR)

K003718 is an FDA 510(k) clearance for TITANIUM CEMENT RESTRICTOR (TCR), manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K003718 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
72d
Days
Class 2
Risk

K003718 is an FDA 510(k) clearance for the TITANIUM CEMENT RESTRICTOR (TCR). 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 February 14, 2001 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K003718

510(k) Number K003718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 04, 2000
Decision Date February 14, 2001
Days to Decision 72 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 42
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K003718.
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
RABEA DEVICE, MODEL PXXXXXX
K990345 · Signus Medizintechnik GmbH · Jul 1999
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
BONE CEMENT RESTRICTOR
K926216 · Biodynamic Technologies, Inc. · Mar 1994