Cleared Traditional

K031673 - REFOBACIN -PALACOS G (FDA 510(k) Clearance)

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

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

Submission Details

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.

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 71
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K031673.
Refobacin Bone Cement R (110034355)
K254107 · Biomet France · Apr 2026
SPECTRUM GV Bone Cement
K250760 · Osteoremedies, LLC · Apr 2025
OSTEOPAL® V
K241674 · Heraeus Medical GmbH · Dec 2024
SPECTRUM® GV Bone Cement
K231556 · Osteoremedies, LLC · Dec 2023
Bone Cement Genta, Bone Cement HV, Bone Cement LV
K211163 · Tecres S.P.A. · Jan 2023
PALACOS MV pro
K213812 · Heraeus Medical GmbH · Feb 2022