Cleared Special

K142157 - PALACOS R+G PRO (FDA 510(k) Clearance)

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

K142157 · Heraeus Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
30d
Days
Class 2
Risk

K142157 is an FDA 510(k) clearance for the PALACOS R+G PRO. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on September 5, 2014 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Heraeus Medical GmbH devices

Submission Details

510(k) Number K142157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2014
Decision Date September 05, 2014
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K142157.
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
Bone Cement-Normal Viscosity
K212729 · Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda · May 2022