Cleared Traditional

SCIENT'X CEMENT RESTRICTOR (K052367) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052367 · Scient'X · Orthopedic device
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Oct 2005
Decision
37d
Days
Class 2
Risk

K052367 is an FDA 510(k) clearance for the SCIENT'X CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Scient'X (Round Rock, US). The FDA issued a Cleared decision on October 5, 2005 after a review of 37 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 Scient'X devices

Submission Details

510(k) Number K052367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 29, 2005
Decision Date October 05, 2005
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K052367.
Mectaplug PE II
K210062 · Medacta International S.A. · Apr 2021
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · Exactech, Inc. · Aug 2002
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · Medtronic Sofamor Danek USA, Inc. · Oct 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · Medtronic Sofamor Danek USA, Inc. · Aug 2001
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · Osteonics Corp. · Oct 1992