CONSTRUX Mini
PTC Spacer System

The CONSTRUX™ Mini PTC Spacer System with Nanovate™ Technology has been designed to optimize anterior cervical procedures with a unique technology that combines PEEK and titanium into a porous interbody solution for the cervical spine. This PEEK / titanium hybrid is designed with its titanium endplates having an optimized porosity and pore size to create a 3D porous material with the potential for bone ingrowth**. The implant also features a PEEK core which allows for post and intraoperative imaging without image distortion. The CONSTRUX Mini PTC Spacer System offers three footprints to address the cervical interbody fusion solution. The implants are available in both parallel and lordotic angles with heights of 6mm-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
  • PEEK core to obtain imaging properties while assessing fusion
  • Large center opening for packing bone grafting material
  • Multiple implant options enable various surgical solutions

Indications

The CONSTRUX Mini PTC 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 PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

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

Contraindications

The CONSTRUX Mini PTC 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