Cleared Traditional

K031673 - REFOBACIN -PALACOS G

K031673 is an FDA 510(k) clearance for REFOBACIN -PALACOS G, manufactured by Heraeus Kulzer GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K031673 · Heraeus Kulzer GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
361d
Days
Class 2
Risk

K031673 is an FDA 510(k) clearance for the REFOBACIN -PALACOS G. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Heraeus Kulzer GmbH & Co. KG (Hanau, DE). The FDA issued a Cleared decision on May 25, 2004 after a review of 361 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 Heraeus Kulzer GmbH & Co. KG devices

FDA 510(k) Submission Details - K031673

510(k) Number K031673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2003
Decision Date May 25, 2004
Days to Decision 361 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
239d slower than avg
Panel avg: 122d · This submission: 361d
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 55
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K031673.
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
SIMPLEX X
K032945 · Stryker Corp. · May 2004
CEMEX GENTA BONE CEMENT
K033596 · Exactech, Inc. · May 2004
VERSABOND AB BONE CEMENT
K022688 · Smith & Nephew, Inc. · Apr 2004