Cleared Traditional

K021788 - NBD CEMENT RESTRICTOR DEVICE

K021788 is an FDA 510(k) clearance for NBD CEMENT RESTRICTOR DEVICE, manufactured by New Business Development, LLC. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K021788 · New Business Development, LLC · Orthopedic device
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Oct 2002
Decision
126d
Days
Class 2
Risk

K021788 is an FDA 510(k) clearance for the NBD CEMENT RESTRICTOR DEVICE. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by New Business Development, LLC (Woodstock, US). The FDA issued a Cleared decision on October 4, 2002 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all New Business Development, LLC devices

FDA 510(k) Submission Details - K021788

510(k) Number K021788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 31, 2002
Decision Date October 04, 2002
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
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 38
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K021788.
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