Cleared Abbreviated

OSTEOPAL V (K050085) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K050085 · Heraeus Kulzer,GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
244d
Days
Class 2
Risk

K050085 is an FDA 510(k) clearance for the OSTEOPAL V. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Heraeus Kulzer,GmbH (Hanau, DE). The FDA issued a Cleared decision on September 14, 2005 after a review of 244 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Heraeus Kulzer,GmbH devices

Submission Details

510(k) Number K050085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2005
Decision Date September 14, 2005
Days to Decision 244 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 122d · This submission: 244d
Pathway characteristics
Standards-based clearance path.

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 K050085.
SIMPLEX P SPEEDSET BONE CEMENT
K053198 · Howmedica Osteonics Corp. · Jan 2006
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
K053445 · DePuy Orthopaedics, Inc. · Jan 2006
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