P O S T E R I O R A X I A L D E V I C E R O M E O 2 PAD DICEMBRE/151… · confidential &...

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

R O M E O® 2 PAD

BIOMECANIC and CARACTERISTIC

P O S T E R I O R A X I A L D E V I C E

Gianluca Maestretti CO-CHIEF OF ORTHOEPEDICS DEPARTEMENT

CHIEF OF SPINAL UNIT

Hospital Cantonal Fribourg

CONFIDENTIAL & PROPRIETARY DO NOT DUPLICATE OR DISTRIBUTE

1.Titanium plate

2.Central PEEK cage

3.Titanium plate

4.Revision screw

The implant consists of:

C O N C E P T & D E S I G N

CENTRAL PEEK CAGE:

The PEEK cage in the central part of the implant is designed to help the fusion process, like the interbody PEEK cages for lumbar interbody fusion.

The graft window in the middle offers the possibility to insert allograft or autograft.


C O N C E P T & D E S I G N


Purpose of the study:

Evaluate the mechanical properties and performances of the ROMEO®2 PAD

interspinous device (Posterior Axial Device) by the mean of static and dynamic tests in a corpectomy model according to the principle of ASTM F1717-11

Additional Dynamic Compression-tension test performed to characterize the attachment of the device to the spinous process


List of predicate devices:

SPIRE PLATE (Medtronic) K032037

ASPEN (Lanx) K071877

AFIX (Nuvasive) K073278

AXLE PEEK (X-Spine) K112592


Static compressive tests on subassemblies (H08 & H18)

115 kg


Static compression & torsion tests / Dynamic compression test

3D view Front view Side view

40

Device assembly on testing blocks


Static compression bending test

Method: Based upon ASTM F1717-11 with modified test blocks that include mock spinous process Constant displacement speed set up at 5 mm/min Vertical force applied to the assembly 40mm behind the anchors of the ROMEO®2 PAD


Static compression bending test

Results: ROMEO®2 PAD yield load 60% greater than predicate(s) ROMEO®2 PAD compression stiffness 63% superior to predicate

60

40

20

0


Static torsion test

Method: Based upon ASTM F1717-11 with modified test blocks that include mock spinous process Speed of rotation equal to 60°/min


Static torsion test

Results: ROMEO®2 PAD yield torque at least equal to predicate


Dynamic compression bending test

Method: Based upon ASTM F1717-11 with modified test blocks that include mock spinous process Duration: 5 million cycles Frequency equal to 4Hz Test performed in a sodium chloride solution at 37°C ± 2°C


Dynamic compression bending test

Results: ROMEO®2 PAD run-out 67% superior to predicate


Dynamic compression-tension test

Device assembly on testing blocks


Method Dynamic compression-tension test

Method: ROMEO®2 PAD tested on specific blocks made of rigid polyurethane foam with grade 40 according to the standard ASTM F1839 (density = 640.7 kg/m3) simulating cortical bone Duration: 5 million cycles Frequency equal to 4Hz Device submitted to a sinusoidal load between a maximal and a minimal value


Dynamic tension-compression test

Results: ROMEO®2 PAD run-out 33% superior to predicate

200

150

100

50

0


THANK‘ YOU

P O S T E R I O R A X I A L D E V I C E

P O S T E R I O R A X I A L D E V I C E R O M E O 2 PAD DICEMBRE/151… · confidential &...

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