Cleared Traditional

K021719 - FORTITUDE CEMENT RESTRICTOR

K021719 is an FDA 510(k) clearance for FORTITUDE CEMENT RESTRICTOR, manufactured by Spinal Concepts, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K021719 · Spinal Concepts, Inc. · Orthopedic device
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Aug 2002
Decision
84d
Days
Class 2
Risk

K021719 is an FDA 510(k) clearance for the FORTITUDE CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on August 15, 2002 after a review of 84 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 Spinal Concepts, Inc. devices

FDA 510(k) Submission Details - K021719

510(k) Number K021719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 23, 2002
Decision Date August 15, 2002
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 34
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K021719.
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
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