Cleared Traditional

K032945 - SIMPLEX X

K032945 is the FDA 510(k) clearance for SIMPLEX X by Stryker Corp.. It is a Class 2 Orthopedic device (product code LOD) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K032945 · Stryker Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
246d
Days
Class 2
Risk

K032945 is an FDA 510(k) clearance for the SIMPLEX X. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on May 25, 2004 after a review of 246 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Stryker Corp. devices

Submission Details

510(k) Number K032945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date May 25, 2004
Days to Decision 246 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
124d slower than avg
Panel avg: 122d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOD Bone Cement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - LOD Bone Cement

All 51
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K032945.
COBALT G HV BONE CEMENT
K051532 · Biomet, Inc. · Aug 2005
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403 · Exactech, Inc. · Dec 2004
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K041656 · DePuy Orthopaedics, Inc. · Jul 2004
CEMEX GENTA BONE CEMENT
K033596 · Exactech, Inc. · May 2004
VERSABOND AB BONE CEMENT
K022688 · Smith & Nephew, Inc. · Apr 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · DePuy Orthopaedics, Inc. · Feb 2004