Cleared Traditional

K030086 - PALACOS R BONE CEMENT WITH GENTAMICIN

K030086 is an FDA 510(k) clearance for PALACOS R BONE CEMENT WITH GENTAMICIN, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K030086 · Biomet, Inc. · Orthopedic device
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Dec 2003
Decision
342d
Days
Class 2
Risk

K030086 is an FDA 510(k) clearance for the PALACOS R BONE CEMENT WITH GENTAMICIN. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 17, 2003 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K030086

510(k) Number K030086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2003
Decision Date December 17, 2003
Days to Decision 342 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 122d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K030086.
VERSABOND AB BONE CEMENT
K022688 · Smith & Nephew, Inc. · Apr 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · DePuy Orthopaedics, Inc. · Feb 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · DePuy Orthopaedics, Inc. · Feb 2004
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · Smith & Nephew, Inc. · Nov 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · DePuy Orthopaedics, Inc. · Sep 2003
CEMEX SYSTEM FAST
K031430 · Exactech, Inc. · May 2003