ROI - LDR Holding

ROI^®

The specifications of the ROI implant satisfy the requirements of lumbar arthrodesis.
The radio-lucent open fusion system, including the MC+® and ROI products provides a wide array of intraoperative options and exclusive technical characteristics.

Geometry
The open geometry of the ROI implant defines its unique characteristics which enhance the quality of bone graft.

Reliability
Independent testing completed by
several laboratories, including
Orthopaedic Research Laboratories,
confirms the reliability of the
ROI & MC+ implants as intervertebral
body replacement devices.

Stable and anatomic
Both the MC+® and the ROI designs
aim to facilitate the restoration of normal
anatomy and attainment of excellent primary stability.

Graft and fusion
The quality and contact surface of the graft are essential for the success of arthrodeses.

Radiolucency and safety
The use of PEEKOptima ®, an advanced polymeric biomaterial with an extensive track record in fusion applications is ideal for follow-up and control.

Sterility and traceability
Optimized management: sterile packaging of implants allows immediate usage upon delivery, without any additional processing. Daily management of implants is therefore simplified.

Geometry
The open geometry of the ROI implant defines its unique characteristics which enhance the quality of bone graft.

A vast, single grafting area and single fusion mass
The role of the large implant-graft volume is to enable vascularization from one vertebra to the other over the largest possible grafting area.

The ROI concept with its opening and peripheral load bearing surfaces favors grafting by allowing the creation of a large single fusion mass.

Restoration of lordosis
Restoration of desired lordosis is possible when placing an implant with a lordosing design. The ROI implant satisfies this requirement through a difference in its antero-posterior height.

The ROI PVBR with its open design and lordosis options facilitates the intraoperative re-creation of normal anatomy.

Reliability
Independent testing completed by several laboratories, including Orthopaedic Research Laboratories, confirms the reliability of the ROI & MC+ implants as intervertebral body replacement devices.

Mechanical testing
Testing of the ROI and MC+® implants was completed by independent laboratories in accordance with ASTM F 2077 (Test Methods for Intervertebral Body Fusion Devices). This testing confirms that the ROI and MC+ provide the necessary mechanical properties to provide primary stability and distribution of loads along the spine segment. These mechanical properties and design of the implants provide conditions necessary for fusion.

ROI Static Axial Compression Test
Average Maximum Load	17014 N
Standard Deviation	944 N
Range	15685 – 18481 N
ROI Dynamic Compression Test
Frequency	5 Hz
Load Cycle	510 – 5100 N
Number of Cycles	5,000,000 (without cracking or deformation)
ROI Dynamic Torsion Test
Frequency	5 Hz
Moment Load Cycle	+/- 2400 N-mm
Number of Cycles	5,000,000 (without cracking or deformation)

Independent testing of ROI and MC+ implants was completed by Orthopaedic Research
Laboratories, CRITT-MDTS and LNE.

Stable and Anatomic
Both the MC+® and the ROI designs aim to facilitate the restoration of normal anatomy and attainment of excellent primary stability.

A peripheral support area outside the grafting area and restoration of lordosis
• The ROI implant makes it possible to recreate a normal anatomic intravertebral space while simultaneously respecting the grafting area and resting as close as possible to the peripheral border of the vertebral end-plate.

Maximum contact surface for optimal stability
• ROI implants are shaped with an opening allowing them to be thicker without reducing the grafting surface. Weight bearing of the ROI implant is therefore applied on a wide, strong and intact bone surface (close to the peripheral border of the vertebral end-plate).

A concept aimed at stability
• As soon as MC+® and ROI PVBR are placed, the serrated profile of the implants ensures their self-retaining properties, until fusion is achieved.

The ROI anterior and posterior heights determine the desired lordosis. They are available in three angulations (0°, 5°, 8°).

Graft and Fusion
The quality and contact surface of the graft are essential for the success of arthrodeses.

A vast grafting area and a single fusion chamber
• The ROI concept favors grafting by creating a single fusion chamber.
• ROI Implants are shaped with an opening allowing them to be thicker without reducing the grafting surface.
• Free contact between the grafts within the open implants allows a “one-and-only” fusion block.

The ROI PVBR enables vascularization from one vertebra to the other over the largest possible area.

Radiolucency and Safety The use of PEEKOptima ®, an advanced polymeric biomaterial with an extensive track record in fusion applications is ideal for follow-up and control.
Radiolucency and consistency • The biocompatibility and mechanical qualities of PEEK-Optima® are largely recognized in fusion applications. • PEEK-Optima® has an elasticity close to that of bone so that there is no graft weight-bearing problem. There is consequently, a biomechanical consistency between two spine segments, the fusion of which can be assessed radiographically. Safety • The MC+® and ROI PVBR are implanted according to a reproducible operating technique. • The serrated profile of the implant ensures their self-retaining properties, until fusion takes place.
	Tantalum markers facilitate intraoperative positioning and follow-up of the PBVR. ROI and MC+® instrumentation was designed by and for spine surgeons.
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Sterility and Traceability in a Compact System Optimized management: sterile packaging of implants allows immediate usage upon delivery, without any additional processing. Daily management of implants is therefore simplified.
Sterilization • All MC+® and ROI implants are delivered in double blister pack sterile packaging, with sterilization control stickers. Absolute traceability • Each implant is absolutely traceable from the initial manufacturing step to the final implantation. Product quality assurance • Sterile packaging ensures the implant is delivered to the surgical field in its original condition. Easypack® • A new implant distribution system for the operating room. This exclusive LDR Spine “sterile implant distribution” system ensures the simple and reliable management of implants in the operating room. A single tray container • ROI and MC+® instrumentation was designed by and for spine surgeons. The result: simple and functional instrumentation.
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