PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PALACOS MV+G EUDAMED
- Device Name
- PALACOS MV+G EUDAMED
- Model / Reference
- 1x40 EUDAMED66031993_Legacy EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260102130920 EUDAMED
- Basic UDI-DI
- B-04260102130920 EUDAMED
- 510(k) Number
- K210607 FDA 510(k)
- FDA Product Code
- LOD FDA 510(k)
- EMDN Code
- P099001 ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3027 FDA 510(k)
- Regulation Number
- 888.3027 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
Yes
The PALACOS R pro, PALACOS R+G pro, and PALACOS MV+G pro are bone cements designed for orthopedic applications, specifically for use in arthroplasty procedures. These products are formulated to provide a reliable fixation medium for joint replacements, with variations in viscosity and optional antibiotic (gentamicin) inclusion to address infection risks.
These bone cements are supplied as sterile, single-use devices intended for intraoperative use in controlled surgical environments. The PALACOS R pro and PALACOS R+G pro feature high-viscosity formulations, while the PALACOS MV+G pro offers medium viscosity. The products are authorized under FDA 510(k) and comply with the Medical Devices Directive (MDD), with regulatory classification as Class II devices. Storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What are the key differences between the PALACOS R pro, PALACOS R+G pro, and PALACOS MV+G pro bone cements in terms of viscosity and formulation?
The PALACOS R pro and PALACOS R+G pro are both high-viscosity bone cements, with the latter including gentamicin to help address infection risks. The PALACOS MV+G pro, however, offers a medium viscosity formulation while also containing gentamicin. These variations allow surgeons to choose based on procedural needs, such as ease of application or infection control.
Are these bone cements intended for reuse, or are they single-use devices?
These PALACOS bone cements are explicitly designed as sterile, single-use devices. They are intended for intraoperative use only and should not be reused after opening or exposure to the surgical environment.
How should these bone cements be stored, and what are the implications for handling?
As sterile medical devices, these PALACOS bone cements must be stored and handled according to standard sterile medical device protocols. This includes maintaining sealed packaging until use, protecting from contamination, and adhering to manufacturer guidelines for temperature and environmental conditions to preserve sterility and performance.
What regulatory pathways have these bone cements followed, and what does that mean for clinicians?
The PALACOS R pro, PALACOS R+G pro, and PALACOS MV+G pro are authorized under the FDA’s 510(k) pathway and comply with the Medical Devices Directive (MDD), classified as Class II devices. This means they have undergone rigorous review by the FDA’s Orthopedic (OR) advisory committee to demonstrate substantial equivalence to previously cleared devices, ensuring they meet safety and effectiveness standards for orthopedic arthroplasty applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PALACOS – Bone Cements for Arthroplasty - Heraeus Medical, PALACOS MV+G pro - Heraeus Medical, PALACOS R+G pro - All-in-One Fixation System™ - Heraeus Medical, PALACOS R+G - High-Viscosity Bone Cement with Gentamicin
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210607 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heraeus Medical GmbH
Sources (2)
- FDA 510(k) K210607 24 fields · synced Oct 6, 2026
- EUDAMED 87767641-c066-4118-b751-de3d00a11432 61 fields · synced Aug 1, 2026