Cleared Traditional

K052367 - SCIENT'X CEMENT RESTRICTOR

K052367 is an FDA 510(k) clearance for SCIENT'X CEMENT RESTRICTOR, manufactured by Scient'X. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K052367 · Scient'X · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K052367

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
Combination Product No
PCCP Authorized No
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.

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 52
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K052367.
INTERBODY INNOVATIONS CEMENT RESTRICTOR
K051371 · Interbody Innovations, Llp · Dec 2005
SKELITE RESORBABLE CEMENT RESTRICTOR
K051836 · Millenium Biologix, Inc. · Nov 2005
NOVASPINE CEMENT RESTRICTOR NSCR
K051607 · Novaspine, LLC · Oct 2005
POLYGRAFT BGS
K041382 · Osteobiologics, Inc. · Jun 2005
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
K052367 · SCIENT'X CEMENT RESTRICTOR
Download PDF FDA Summary Scient'X