Cleared Traditional

PALACOS LV+G (K050854) - FDA 510(k) Clearance

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

K050854 · Heraeus Kulzer,GmbH · Orthopedic device
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Jul 2005
Decision
94d
Days
Class 2
Risk

K050854 is an FDA 510(k) clearance for the PALACOS LV+G. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Heraeus Kulzer,GmbH (Wehrheim, DE). The FDA issued a Cleared decision on July 7, 2005 after a review of 94 days - within the typical 510(k) review window.

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 Heraeus Kulzer,GmbH devices

Submission Details

510(k) Number K050854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2005
Decision Date July 07, 2005
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 47
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K050854.
DEPUY CMW 1, 2 AND 3 BONE CEMENTS
K053003 · DePuy Orthopaedics, Inc. · Nov 2005
COBALT BONE CEMENT
K051496 · Biomet, Inc. · Aug 2005
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