Cleared Traditional

K033953 - OPTIMESH 500E CEMENT RESTRICTOR

K033953 is an FDA 510(k) clearance for OPTIMESH 500E CEMENT RESTRICTOR, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K033953 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
197d
Days
Class 2
Risk

K033953 is an FDA 510(k) clearance for the OPTIMESH 500E CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Spineology, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 6, 2004 after a review of 197 days - an extended review 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: 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 Spineology, Inc. devices

FDA 510(k) Submission Details - K033953

510(k) Number K033953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 22, 2003
Decision Date July 06, 2004
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
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 31
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K033953.
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698 · Life Spine · Jul 2006
LIFE SPINE CEMENT RESTRICTOR
K060247 · Life Spine · May 2006
PEEK CEMENT RESTRICTOR X-BOX
K041583 · Innovasis, 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