Cleared Traditional

K040276 - QUANTUM CEMENT RESTRICTOR

K040276 is an FDA 510(k) clearance for QUANTUM CEMENT RESTRICTOR, manufactured by Quantum Orthopedics. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K040276 · Quantum Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
85d
Days
Class 2
Risk

K040276 is an FDA 510(k) clearance for the QUANTUM CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Quantum Orthopedics (San Diego, US). The FDA issued a Cleared decision on April 30, 2004 after a review of 85 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 Quantum Orthopedics devices

FDA 510(k) Submission Details - K040276

510(k) Number K040276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2004
Decision Date April 30, 2004
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K040276.
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699 · Amedica Corp. · Apr 2005
PEEK CEMENT RESTRICTOR X-BOX
K041583 · Innovasis, Inc. · Jul 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · Spineology, Inc. · Jul 2004
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · Implex Corp. · Nov 2003
NUVASIVE CEMENT RESTRICTOR
K032180 · Nuvasive, Inc. · Oct 2003
TRAXIS CEMENT RESTRICTOR
K031318 · Spinal Concepts, Inc. · Aug 2003