LDR is now Zimmer Biomet

Product Overview

ROI-C® is a novel system designed for zero-profile, stand-alone* anterior cervical interbody fusion. The ROI-C Cervical Cage is available in a variety of profiles, heights, and footprints designed to match the patient’s anatomy and provide initial and long-term stability. The cage accommodates integrated,
self-guided, self-locking VerteBRIDGE® plating designed to provide stability with no instrumentation protruding anterior of the vertebral bodies. The
self-guided, curved VerteBRIDGE plates are delivered in the plane of the disc through a direct anterior approach, so that the surgery can be achieved with less exposure than may be required to implant a traditional cervical plate, or even contemporary stand-alone systems with screws that must be inserted at oblique and challenging angles.

The system features thoughtfully designed instrumentation including an inserter that protects anatomical structures when placing the cage and VerteBRIDGE Plating.

* In cases of trauma, vertebral instability, or significant bone removal, the
ROI-C implant should be augmented with additional supplemental fixation.

Features

Available in two designs

The two sagittal profiles are designed to respect the patient’s anatomy and allow close contact between the bone and the implant, and to provide restoration of both height and lordosis.

  • Anatomic - Designed with a superior surface that complements healthy endplate contours
  • Lordotic - Tapered profile for patients with non-concave, flattened endplates

Stable and modular

  • Large peripheral weight bearing area, serrated profile, and the implants’ shapes enhance primary stability via immediate loading
  • Available in multiple footprints and heights to fit diverse spine anatomy

Optimized, large, central graft chamber for autograft bone

 

Radiolucent PEEK cage delivered in sterile packaging for quality and traceability

 

Simplified operative procedure

  • Designed by and for spine surgeons resulting in simple and functional instrumentation for an anterior mini-open technique

VerteBRIDGE® Plating Technology

  • Novel stand-alone technology*
  • Zero-profile design with no hardware protruding anterior of the vertebral bodies
  • Self-locking plates designed for initial and long-term stability
  • Anterior mini-open technique for insertion in the transverse plane
  • Adjustable anterior-posterior placement prior to insertion of the plate
  • Self-guided, curved plates ease insertion
  • Inserter provides protection of vascular structures during plate placement

* In cases of trauma, vertebral instability, or significant bone removal, the ROI-C implant should be augmented with additional supplemental fixation.

Request Information

 

Multimedia

MRI Safety Information

Non-clinical testing has demonstrated that the Interbody Cage Systems are MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T) only.
  • Maximum spatial gradient field of 3000 G/cm (30 T/m) or less.
  • Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of 3.2-3.5 W/kg for 1.5 T systems and 3.2-3.6 W/kg for 3 T systems.
  • When other methods of supplemental fixation are used, also follow the MR conditional labeling for the additional components.

Under the scan conditions defined above, the ROI-C Implant System is expected to produce a maximum temperature rise of 0.2°C for 1.5 T systems and 0.6°C for 3 T systems after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 0.8cm from the ROI-C Implant when imaged with a gradient echo pulse sequence in either a 1.5T or a 3T MRI system. 

Indications for Use

The ROI-C Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2–T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

NOTE: VerteBRIDGE® Plating is the supplemental fixation designed specifically for the ROI-C cage and can be used in applications where a stand-alone anterior construct is appropriate. Additional supplemental fixation options that can be used with the ROI-C cage (with or without VerteBRIDGE Plating) include posterior screw/rod systems and/or additional vertebral plating.