Arcadius^XP L®

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Stand-Alone Interbody Device (SIBD)

Product Picture Enlargement CW — Arcadius XP L®

The Arcadius^XP L^® Interbody Fusion System is a stand-alone device intended to be used with four bone screws if no supplement fixation is used to stabilize the lumbar spine through an anterior approach.

Arcadius^XP L^® combines high primary and secondary stability ^{[1, 2]} and improved imaging properties ^[3]. PLASMAPORE^XP® osteoconductive coating was developed to promote implant stability and bony ingrowth ^{[1, 2]}.

Implant design and flexible instrumentation allow an accessibility from a wide range of angles for instrumentation and hence provide ease in screw insertion.

System Features

PLASMAPORE^XP® coating
Wide variety of implant options
Generous graft window
Surface texturing
Five X-Ray marker pins
Midline accessibility for screw insertion
Diverging screw design
Dual locking mechanism
Self-centering, self-drilling and self-tapping bone screws
Comprehensive array of instrumentation

Implant Design

Built on experience
Aesculap has many years of experience in applying PLASMAPORE^® coatings to titanium orthopaedic and spine implants ^[4-6] to develop the PLASMAPORE^XP® coating for PEEK spinal implants.
Innovative surface enhancing technology
PLASMAPORE^XP® is an osteoconductive pure titanium coating (Ti/ISO 5832-2) which enables bone ingrowth due to its balanced relation between pore depth, porosity and roughness ^[1].
Enhanced stability
The benefits of PLASMAPORE^XP® in combination with the diverging screw design contribute to the implant stability ^{[2, 7]}.
Implant fit
Wide variety of implant sizes are designed to fit with varying patient anatomies.
Accessibility from diverse angles
Implant design and flexible instrumentation allow an accessibility from a wide range of angels for instrumentation and hence provide ease in screw insertion.
Simple locking mechanism
Integrated dual locking mechanism with single-step activation.
Excellent imaging properties
The PLASMAPORE^XP® coating together with the X-ray marker pins allow the visualization of implant contour and localization ^[3].

Intended Use

The system contains:

Cages in different heights, angles and footprints
Bone screws in different lengths

Levels of anterior lumbar interbody fusion for the indications listed in the instructions for use are from L2-S1.

Note

For further information please see instructions for use TA-No. 015555.

[1] Cheng BC, Koduri S, Wing CA, Woolery N, Cook DJ, Spiro RC. Porous titanium-coated polyetheretherketone implants exhibit an improved bone-implant interface: an in vitro and in vivo biochemical, biomechanical, and histological study. MDER 2018; 11:391–402.

[2] Fink U. Plasmapore: A plasma-sprayed microporous titanium coating to improve the long-term stability. Acutalités en Biomatériaux. 1996;III:97-104.

[3] Gaißer, Marco. X-ray and CT visibility of a vacuum plasma spray pure titanium coating on PEEK substrate. Tuttlingen, 2011.

A radiological visibility test was performed using a PEEK implant sample coated with vacuum plasma spray (VPS) titanium. The sample was implanted in a adjacent vertebral body segment of a human spine specimen. Results show that the VPS coating on PEEK substrate increases the visibility of the implant in X-ray and CT images. Artefacts were also not observed in the X-ray and CT images.

[4] Swamy G, Pace A, Quah C, Howard P. The Bicontact cementless primary total hip arthroplasty: Long-term results. Int Orthop (SICOT) 2010.

[5] Kroppenstedt S, Gulde M, Schönmayr R. Radiological comparison of instrumented posterior lumbar interbody fusion with one or two closed-box PLASMAPORE® coated titanium cages. Follow-up study over more than seven years. Spine. 2008;33(19):2083-8.

[6] Arregui R, Aso J, Martinez-Quinones JV, Consolini F, Lamban N, Dominguez M. Cespace: Cervical interbody fusion system. Preliminary retrospective study in 104 cases (120 implants). Neurocirugia. 2011; 22:542-53.

[7] Shah, Vinay. Mechanical testing of the Aesculap Arcadius XP System. Breinigsville, 2011.

Testing was undertaken to determine the mechanical properties for the Aesculap Arcadius XP System. The following static testing were conducted: axial compression, shear compression and torsion (in a load to failure mode), subsidence, and expulsion (with and without screws). The tests were conducted according to the corresponding ASTM standards. Based on the results, the risk of implant failure as dislocation or deformity due to forces at a physiological load situation is unlikely to occur in the case of the AESCULAP® Arcadius XP L® implant.