Frequently Asked Questions

History and Portfolio

Heraeus Medical known as a global leader in joint fixation and infection management in orthopedics and trauma surgery. This enables the company to make an important contribution to supporting surgeons and the surgical team and to improve surgery outcomes. In the area of biomaterials, Heraeus Medical focuses on products for use in bone and joint surgery. The core product PALACOS® is considered the gold standard among bone cements1 and has repeatedly proven itself over six decades of clinical use.

Our product portfolio comprises an extensive range of high-quality bone cements, mixing and delivery systems, and preformed spacers. PALACOS® cements are available in various viscosities for flexible handling during different orthopedic procedures, with 60 years of quality to support outstanding survivorship after arthroplasty.2

All Heraeus mixing systems have been developed for use with PALACOS® cements, and all our traditional cements (R/+G, MV/+G, LV/+G) are recommended for vacuum mixing. (PALACOS® fast R+G is not recommended for vacuum mixing due to its lack of a waiting phase.)

CEMENTS:

    • PALACOS® R /+G* is a high-viscosity bone cement with 60 years of proven clinical history.
    • PALACOS® MV /+G* is a medium-viscosity bone cement, providing increased phase flexibility.
    • PALACOS® LV /+G* is a low-viscosity bone cement, ideal for precise application even through thin nozzles.
    • PALACOS® fast R+G* is a fast-setting, high viscosity bone cement with Gentamicin for experienced surgeons

* Antibiotic-loaded bone cement is indicated for use in the second stage of a two-stage revision after the initial infection has been cleared.

MIXING AND DELIVERY:

  • PALACOS® R /+G pro All-in-One Fixation System™ integrates the renowned quality of PALACOS® bone cements into a ready-to-mix closed vacuum system.
  • The PALAMIX® cartridge vacuum mixing system has been developed to deliver perfectly homogeneous PALACOS® cement and is paired with our award-winning PALAMIX® CEMENT GUN for simple and effective bone cement delivery.
  • The PALABOWL® vacuum mixing bowl provides a value option to simplify cement preparation and improve cement consistency.

PRE-FORMED SPACERS:

  • COPAL® exchange G is the only preformed spaces that integrates minimized wear and outstanding stability into an easy-to-use preformed design.

Usage and Clinical Superiority

PALACOS® bone cement has more JBJS Criteria 1 studies performed on it than any other bone cement on the market. In fact, PALACOS® cements have been used in 3.4 times the number of clinical research studies than all other US bone cements, combined.4

Admixing (or, adding antibiotic by hand during the mixing process) can compromise the integrity and mechanical properties of the cement in several ways.

Due to variations in their manufacturing procedures, the admixing of antibiotics can significantly reduce cement fatigue strength5, directly affecting aseptic loosening. Additionally, manually admixed cement has been found to not elute above the minimum inhibitory concentration (MIC) for Staph. aureus6, and to also show a poorer zone of inhibition in comparison to commercially premixed bone cements.7

Closed mixing systems, such as the PALACOS® R /+G pro All-In-One-Fixation-SystemTM, provide protection not just for the cement during mixing and setting, but also the staff and patients in the operating room. The enclosed system prevents bacteria or particulate contaminants from getting into the cement during mixing. This also prevents the cement from aerosolizing, hitting contaminated surfaces, and falling into the wound. Closed mixing systems also greatly reduce staff and patient exposure to MMA fumes, and the PALACOS® pro All-In-One-Fixation-System has been shown to reduce MMA fumes by up to 800% compared to other preloaded, contained systems.8

The concentration of methyl methacrylate (MMA) in the air during the mixing and application of bone cement is well below the permissible workplace limits (~50ppm/m3). A literature review reveals that when mixing the cement in an open bowl the MMA concentration is about 8ppm/m3, and by using a vacuum mixing device this is reduced to 4ppm/m3.7

Pregnant animal studies showed that MMA vapors were not toxic or teratogenic.8 However, there are no statistically relevant human studies on MMA that involve pregnant or lactating women working in the operating room environment. In order to minimize the absolute risk, we therefore recommend not exposing pregnant or lactating women to any MMA vapors.

Manufacturing and Supply Chain

While international supply chains are affected by the current situation, Heraeus Medical has significant inventory of PALACOS® bone cement in the United States, at our production site in Germany, and in our warehouses.

In addition to ensuring timeliness of our supplies, we remain committed to avoiding quality risks in our supplies.

Unlike “trunk stock delivery,” our delivery process ensures the cement is not exposed to temperatures and conditions which will degrade its performance in surgery or in vivo. We do not support a “rep carry in” process, as it lacks quality control and may increase pathogens in the OR.

All our cements are manufactured in a clean room environment and undergo over 130 computer automated checkpoints throughout production. For more information click here .

Yes, you are still receiving the same version of PALACOS® as what has been made for 60 years and used in over 30 million cases. The PALACOS® within is still manufactured in a single site in Wehrheim, Germany by Heraeus Medical under exacting specifications. The only thing that has changed is the new green design on the box.

Our previous packaging in the United States had a blue pattern based on the brand standards of our prior distribution partner. With Heraeus Medical directly entering the US market in 2018, we are updating our packaging to reflect our brand standards and standardize our packaging with what is distributed in the rest of the world.

You do not need to update anything about how you are ordering PALACOS® products from Heraeus Medical. As the product has remained unchanged, you can use the exact same stock keeping unit for ordering.

Nothing has changed about PALACOS® R or PALACOS® R+G bone cements as they have always been high viscosity bone cements. The viscosity of a bone cement refers to how long various phases of the polymerization reaction lasts. High viscosity bone cements have a short wetting phase and lose their stickiness quickly after mixing. At this point, the bone cement is ready for application and high viscosity bone cements, like PALACOS® R, provide an especially long working phase.11 The polymerization reaction for PALACOS® R and PALACOS® R+G remains unchanged and it continues to provide one of the longest and most consistent working times.12

The sterility and integrity of cement can be compromised by any number of factors, including temperature and humidity while in its packaging.

Unlike trunk stock delivery, our delivery process ensures the cement is not exposed to temperatures and conditions which will degrade its performance in surgery or in vivo. We do not support a “rep carry in” process as it lacks quality control and may increase pathogens in the OR.

All of our cement is manufactured in a clean room environment and undergoes over 130 computer automated checkpoints throughout production. Heraeus Medical also pioneered the sterilization of bone cement with ethylene oxide (EO).

1 Olerud et al: Comparison of Refobacin Bone Cement and Palacos with Gentamicin in total hip arthroplasty: an RSA study with two years follow-up. Hip int., 2013 p 1
2 NJR Supplier Feedback Report, Q4 2019
3 Siegel G, et al. Cost Analysis and Surgical Site Infection Rates in Total Knee Arthroplasty Comparing Traditional vs. Single-Use Instrumentation. The Journal of Arthroplasty. 2015; v30 12 2271-2274
4 Pilz V, Hanstein T. A Literature Review of the Clinical Evidence Situation of Bone Cements. Journal of Medical and Health Sciences. 2018;1:31-36
5 Lilikakis A, Sutcliffe M. The Effect of Vancomycin Addition to the Compression Strength of Antibiotic-Loaded Bone Cement. International Orthopaedics 2009; 33; 815–819
6 Neut, D. et al. The effect of mixing on gentamicin release from polymethylmethacrylate bone cements. Acta Orthop Scand, 2003; 74(6): 670-676
7 Ferraris S, Miola M, Bistolfi A, et al. In vitro comparison between commercially and manually mixed antibiotic-loaded bone cements. J Appl Biomater Biomech 2010; 8(3): 166-174
8 Jelecevic J, et al. Methyl Methacrylate Levels in Orthopedic Surgery: Comparison of Two Conventional Vacuum Mixing Systems. Ann Occup Hyg 2014; 58(4): 493-500
9 Schlegel UJ, et al. Efficacy of vacuum bone cement mixing systems in reducing methylmethacrylate fume exposure: comparison of 7 different mixing devices and hand mixing. Acta Orthop Scan; 75; 559 – 566
10 Singh A.R., Lawrence W.H., Autian J; Embryonic fetal toxicity and teratogenic effects of a group of methylmethacrylate esters in rats. J. Dent Res. 51; 1632 – 1638
11 Kuehn KD. Properties of Cement Dough in PMMA Cements. Springer: Berlin, 2014. pgs 94-97
12 Dall GF, et al. Inter- and intra-batch variability in the handling characteristic and viscosity of commonly used antibiotic-loaded bone cements. Acta Orthop 2007; 78(3): 412-429