CONSTRUX Mini Ti Spacer System

The CONSTRUX™ Mini Ti Spacer System with Nanovate™ Technology has been developed to enhance anterior cervical procedures with a 3D-printed titanium cervical interbody designed with a functional gradient porous structure. This implant has an optimized porosity and pore size which creates a 3D porous surface with the potential for bone ingrowth**. The CONSTRUX Mini Ti Spacer System offers four footprints to address the cervical interbody fusion solution. The implants are available in both parallel and lordotic angles with heights of 5mm-12mm in one-millimeter increments.

Unique Design Characteristics

  • 3D porous titanium with macro, micro, and nano-scale surface features
  • The nano-scale surface has been shown to increase proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells in vitro*
  • 3D-printed titanium endplates with 400 micron pores and 50% porosity are designed to help facilitate bone ingrowth**
  • The endplates consist of interconnected gyroid structures analogous in form to trabecular bone which provide an open porous environment
  • Functional gradient porous structure with 80% porosity at the midline of the implant allows for increased fluoroscopic visualization
  • Large center opening with concaved inner walls for packing bone grafting material
  • Hyperlordotic profile option
  • Multiple implant options enable various surgical solutions

Indications

The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini Ti Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

Contraindications

The CONSTRUX Mini Ti Spacer System, as with other orthopedic implants, is contraindicated for use in patients with:

  • Active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection.
  • Rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation.
  •  Conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system in such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
  • Prior fusion at the level to be treated.​​

Footnotes

*In vitro performance may not be representative of clinical performance
** As suggested in an in-vivo ovine lumbar spinal fusion model

Instructions For Use