SkyBoneCement — radiopaque PMMA bone cement in high, medium and low viscosity, with and without antibiotic. Developed and manufactured by SKY Biotechnology.
Polymethyl methacrylate (PMMA) based bone cement is a widely used biomaterial due to its ease of use in clinical practice and its long survival rate, especially with prosthetics. Bone cements have been used successfully to anchor artificial joints for more than half a century: the cement fills the free space between the prosthesis and the bone and acts as an elastic zone. SkyBoneCement is a radiopaque PMMA bone cement supplied in three viscosity variants, as two lines — SkyPureBond without antibiotic and SkyCureBond with gentamicin sulphate.
One PMMA platform, two lines, three viscosities.
The PMMA platform behind both lines. Two components: liquid monomer and powdered polymer. The liquid consists of methyl methacrylate with dimethyl-para-toluidine as activator and hydroquinone as stabiliser; the powder consists of PMMA with dibenzoyl peroxide and a barium sulphate radiopacifier.
Standard bone cement, without antibiotic. Indicated for vertebroplasty, cranioplasty, kyphoplasty and orthopaedic use. Model codes SH, SM and SL by viscosity, in 20, 40 and 60 gr.
Antibiotic bone cement containing gentamicin sulphate, to support infection control. Model codes SAM20, SAM40 and SAM60.
| Indication | SkyPureBond | SkyCureBond | Preparation ends | Application ends | Final set | |
|---|---|---|---|---|---|---|
| High viscosity | Vertebroplasty · kyphoplasty | SH20 · SH40 · SH60 | — | 1.5 min | 6 min | 11 min |
| Medium viscosity | Arthroplasty | SM20 · SM40 · SM60 | — | 3.5 min | — | 13 min |
| Low viscosity | Cranioplasty | SL20 · SL40 · SL60 | — | — | — | 15 min |
| Antibiotic (all viscosities) | Infection control | — | SAM20 · SAM40 · SAM60 | — | — | — |
All variants supplied in 20, 40 and 60 gr. Setting times are the values marked in the product catalogue; unmarked intermediate boundaries are shown as “—”. Refer to the Instructions for Use for the full intended purpose, contraindications and warnings.
Per the Instructions for Use. Intended for use by qualified healthcare professionals.
SkyCureBond is the antibiotic line of the SkyBoneCement platform: a radiopaque, self-curing polymethyl methacrylate (PMMA) cement supplied as a two-component system, a liquid monomer and a powdered polymer, with gentamicin sulphate carried in the powder phase. It answers two problems at once in prosthetic surgery. First, mechanical: the cement fills the free space between prosthesis and bone and acts as an elastic zone, anchoring the implant and distributing load across the interface. Second, microbiological: the gentamicin sulphate dispersed through the cement supports infection control at the site during arthroplasty and cranioplasty. SkyCureBond is coded in its own antibiotic series, SAM20, SAM40 and SAM60, is CE marked, and is manufactured in-house by SKY Biotechnology under an ISO 13485 certified quality management system.
Component-level view of the SkyBoneCement platform. Refer to the Instructions for Use for the full intended purpose, contraindications and warnings.
| Component | Phase and role | Clinical advantage | Certification |
|---|---|---|---|
| Methyl methacrylate | Liquid monomer, the reactive base of the system | Polymerises with the powder phase to form the cement mantle that anchors the implant and acts as an elastic zone between prosthesis and bone | CE marked · ISO 13485 certified QMS |
| Dimethyl-para-toluidine | Liquid phase, activator | Drives polymerisation at room temperature, giving the surgeon a defined working window | CE marked · ISO 13485 certified QMS |
| Hydroquinone | Liquid phase, stabiliser | Prevents premature polymerisation of the monomer, protecting shelf stability and predictable setting behaviour | CE marked · ISO 13485 certified QMS |
| Polymethyl methacrylate (PMMA) | Powder phase, the polymer bulk | The biomaterial that has anchored artificial joints for more than half a century, chosen for ease of handling and long implant survival | CE marked · ISO 13485 certified QMS |
| Dibenzoyl peroxide | Powder phase, initiator | Initiates the polymerisation reaction on mixing, working with the activator to control the set | CE marked · ISO 13485 certified QMS |
| Barium sulphate | Powder phase, radiopacifier | Gives high radio-opacity, so the thickness and continuity of the cement mantle can be assessed on intraoperative and follow-up imaging | CE marked · ISO 13485 certified QMS |
| Gentamicin sulphate, in SkyCureBond only | Powder phase, antibiotic | Supports infection control during arthroplasty and cranioplasty; the basis of the SAM20, SAM40 and SAM60 series | CE marked · ISO 13485 certified QMS |
In total joint arthroplasty the cement is not a filler but a load-bearing interface, and its handling profile decides how well that interface is built. SkyCureBond sits on the same PMMA platform as the standard SkyPureBond line, in three viscosities with working times tuned to each: the medium-viscosity variant is the arthroplasty grade, with preparation ending at 3.5 minutes and final set at 13 minutes, while the high-viscosity grade sets at 11 minutes for vertebroplasty and kyphoplasty and the low-viscosity grade at 15 minutes for cranioplasty. A defined preparation-to-set window lets the surgeon pressurise the cement into cancellous bone at the right moment, widening the surface available for micro-interlock and helping distribute interface stresses more evenly, which is the mechanical argument against radiolucent lines and aseptic loosening. The barium sulphate radiopacifier means the mantle can be read directly on imaging rather than inferred. Where infection risk is elevated, in revision work or in compromised hosts, the gentamicin sulphate in SkyCureBond adds local antibiotic cover without changing the handling characteristics already familiar from SkyPureBond, since both lines share one chemistry, three viscosities and the same 20, 40 and 60 gram presentations. Grade selection, mixing technique and indication remain matters of clinical judgement under the Instructions for Use.
Common questions from distributors and surgeons about SkyBoneCement.
Both are built on the same SkyBoneCement PMMA platform, with the same three viscosities and the same 20, 40 and 60 gram presentations. SkyPureBond is the standard cement without antibiotic, indicated for vertebroplasty, cranioplasty, kyphoplasty and orthopaedic use, and coded SH, SM and SL by viscosity. SkyCureBond adds gentamicin sulphate to the powder phase to support infection control during arthroplasty and cranioplasty, and is coded SAM20, SAM40 and SAM60.
High viscosity is directed at vertebroplasty and kyphoplasty, with preparation ending at 1.5 minutes and final set at 11 minutes. Medium viscosity is the arthroplasty grade for prosthetic fixation, with preparation ending at 3.5 minutes and final set at 13 minutes. Low viscosity is directed at cranioplasty, with final set at 15 minutes. These are the values marked in the product catalogue; the Instructions for Use govern in every case.
The code carries three pieces of information: S for Sky, then the viscosity letter H, M or L for high, medium or low, then the grams of the presentation, 20, 40 or 60. So SM40 is a medium-viscosity forty-gram cement. The antibiotic line uses its own root, SAM, followed by the same gram figure.
Barium sulphate in the powder phase makes the cement visible under imaging. This lets the surgeon assess the thickness and continuity of the cement mantle during the procedure and at follow-up rather than inferring it, and it makes the interface auditable if the joint is later revised.
SkyBoneCement is developed and produced in-house by SKY Biotechnology at its own facility in Pendik, Istanbul, Turkiye, under an ISO 13485 certified quality management system, and is CE marked. The company exports to more than fifty countries.
Technical specifications, regulatory documentation and catalogs are available to qualified partners on request.
Product information is provided for healthcare professionals, distributors and business partners and does not constitute medical advice. Availability, specifications and regulatory status may vary by country.