Ronda Medical
SIGNUS Medical

ROTAIO® — Cervical disc prosthesis

Cervical disc prosthesis that preserves the physiological mobility of the segment — "implanted like a cage, moves like a disc".

NeurosurgeryOrthopedics
Request a quote
ROTAIO® — the 4 footprints and 2 heights of the cervical disc prosthesis (official SIGNUS render)
C3–C7Segment
4Footprints
5 / 6 mmHeights
CoCrMoArticulation
Clinical description

ROTAIO® is a cervical intervertebral disc prosthesis developed by SIGNUS for the specific demands of the cervical spine (C3–C7). The aim of the prosthesis is to reproduce the natural motion of a healthy intervertebral disc — not only preserving motion, but also its quality.

The prosthesis is of the unconstrained type, with a variable center of rotation. In addition to rotation, flexion/extension, and lateral bending, ROTAIO® also allows uncoupled translation, thereby providing segmental motion physiologically guided by the facets, without gaping of the joints. The articulating surfaces are made of cobalt-chromium-molybdenum alloy (CoCrMo), and the endplates of titanium alloy (Ti-6Al-4V) with a roughened surface for osseointegration.

The one-piece design allows safe handling: ROTAIO® is implanted "in one piece", using the established Smith–Robinson technique. The large footprints maximize contact with the vertebral body and help prevent unwanted fusion of the segment, while the endplate teeth (adopted from the RABEA® cages) provide primary stabilization without preparation of a keel and with minimal bone resection. The prosthesis was developed in collaboration with Univ.-Prof. Dr. Claudius Thomé (Innsbruck).

Indications
  • Cervical disc arthroplasty (disc replacement) for symptomatic degenerative disc disease, at a single level.
  • Cervical segment C3–C7.
  • Preservation of the physiological mobility of the segment, with restoration of disc height.
Key features

Physiological mobility

Variable center of rotation, with uncoupled translation and facet-guided motion (unconstrained).

One-piece design

Implantation "like a cage", using the Smith–Robinson technique, for safe handling.

Tooth fixation

The endplate teeth (RABEA®) provide primary stability without a keel, with minimal bone resection.

Large footprints

Maximum contact with the vertebral body, for safe positioning and reduced risk of subsidence.

Product gallery
ROTAIO® — the 4 footprints and 2 heights of the cervical disc prosthesis (official SIGNUS render)
ROTAIO® — the 4 footprints and 2 heights of the cervical disc prosthesis (official SIGNUS render)
ROTAIO® — flexion/extension images: physiological, facet-guided motion
ROTAIO® — flexion/extension images: physiological, facet-guided motion
Technical specifications
Type
Unconstrained, one-piece cervical disc prosthesis with a variable center of rotation
Level
Cervical spine C3–C7
Footprints (width × depth)
15×13 · 17×13 · 17×15 · 19×15 mm
Heights
5 mm and 6 mm (excluding tooth height; others on request)
Articulating surfaces
Cobalt-chromium-molybdenum alloy (CoCrMo)
Endplates
Titanium alloy (Ti-6Al-4V), roughened surface for osseointegration
Motions
Rotation, flexion/extension, lateral bending, uncoupled translation
Technique
Smith–Robinson; no keel preparation; sterile, single-use supply
Clinical evidence

A selection of publications and studies that mention use of the system. Summaries are indicative; for details, consult the original source.

Prospective multicenter trial of cervical arthroplasty with the ROTAIO® disc prosthesis

Fleck S., Thomé C. și colab. · Global Spine Journal, 2022 (AO Spine)

Observational, prospective, multicenter clinical study that evaluated the clinical outcome and complications at 2 years after cervical arthroplasty (ACDA) with the ROTAIO® prosthesis — an unconstrained implant with a variable center of rotation, targeting physiological motion. In 120 patients (median age 43 years), significant clinical improvements were observed.

≥15% decrease in NDI in ≥90% of patients at 24 months; reduction in analgesic use (95.2%) and in physician visits (93.8%).
View source
Certifications & compliance
CE marking FDA-cleared (USA)
Resources
Product information (SIGNUS) Study: Fleck et al., Global Spine Journal 2022

Would you like information about ROTAIO® — Cervical disc prosthesis?

The Ronda Medical team provides details about availability, configurations, and technical support.

Contact the team